Sleep-related Quality Of Life Research Articles

CPAP Treatment Improves Quality of Life and Self-perception of Voice Impairment in Patients with OSA

The purpose of this study is to examine vocal fatigue and impairment, gastroesophageal symptoms, dysphagia risk, and sleep-related quality of life in individuals with obstructive sleep apnea (OSA) who have been treated with continuous positive airway pressure (CPAP) compared to those who have not received treatment. Fifty-four participants diagnosed with OSA completed an online research form. Of these, 29 were receiving CPAP treatment, while 25 were not undergoing treatment. The following instruments were used: Vocal Fatigue Index, Voice Handicap Index, Gastroesophageal symptoms, Eating Assessment Tool, and Quebec Sleep Questionnaire. The group that received CPAP treatment had significantly lower scores in the functional domain and total Voice Handicap Index. They also experienced fewer symptoms of regurgitation, reduced daytime sleepiness, fewer nocturnal symptoms, and better emotional and social interactions in their quality of life compared to the untreated group. There were no significant differences in voice fatigue and dysphagia risk between the groups. Individuals treated with CPAP experience reduced vocal impairment, fewer regurgitation symptoms, and improvement in the emotional and social interactions domains of their quality of life compared to individuals without treatment.

Acceptance and Commitment Therapy, Combined with Bedtime Restriction, versus Cognitive Behavioral Therapy for Insomnia: A Randomized Controlled Pilot Trial

Introduction: Cognitive behavioral therapy for insomnia (CBT-I) is the current first-line treatment for insomnia. However, rates of nonresponse and nonremission are high and effects on quality of life are only small to moderate, indicating a need for novel treatment developments. We propose that Acceptance and Commitment Therapy (ACT) addresses core pathophysiological pathways of insomnia. ACT therefore has the potential to improve treatment efficacy when combined with bedtime restriction, the most effective component of CBT-I. The aim of this study was to compare the efficacy of ACT for insomnia combined with bedtime restriction (ACT-I) and CBT-I in improving insomnia severity and sleep-related quality of life. Methods: Sixty-three patients with insomnia disorder (mean age 52 years, 65% female, 35% male) were randomly assigned to receive either ACT-I or CBT-I in a group format. The primary outcomes were insomnia severity (Insomnia Severity Index) and sleep-related quality of life (Glasgow Sleep Impact Index). Outcomes were assessed before randomization (T0), directly after treatment (T1), and at 6-month follow-up (T2). Results: The results indicated significant, large pre-to-post improvements in both groups, for both primary and secondary outcomes. Improvements were maintained at the 6-month follow-up. However, there was no significant group by time interactions in linear mixed models, indicating an absence of differential efficacy. On a subjective treatment satisfaction scale, patients in the ACT-I group indicated significantly greater satisfaction with their improvement of several aspects of health including their energy level and work productivity. Conclusions: The results suggest that ACT-I is feasible and effective, but not more effective than CBT-I for the improvement of insomnia severity and sleep-related quality of life. Future studies are needed to assess whether ACT-I is noninferior to CBT-I and to shed light on mechanisms of change in both treatments.

Protocol for a pragmatic trial testing a self-directed lifestyle program targeting weight loss among patients with obstructive sleep apnea (POWER Trial)

BackgroundObesity comprises the single greatest reversible risk factor for obstructive sleep apnea (OSA). Despite the potential of lifestyle-based weight loss services to improve OSA severity and symptoms, these programs have limited reach. POWER is a pragmatic trial of a remote self-directed weight loss care among patients with OSA. MethodsPOWER randomizes 696 patients with obesity (BMI 30–45 kg/m2) and recent diagnosis or re-confirmation of OSA 1:1 to either a self-directed weight loss intervention or usual care. POWER tests whether such an intervention improves co-primary outcomes of weight and sleep-related quality of life at 12 months. Secondary outcomes include sleep symptoms, global ratings of change, and cardiovascular risk scores. Finally, consistent with a hybrid type 1 approach, the trial embeds an implementation process evaluation. We will use quantitative and qualitative methods including budget impact analyses and qualitative interviews to assess barriers to implementation. ConclusionsThe results of POWER will inform population health approaches to the delivery of weight loss care. A remote self-directed program has the potential to be disseminated widely with limited health system resources and likely low-cost.

The Sleepio After Cancer (SAC) study. Digital cognitive behavioural therapy for insomnia (dCBT-I) in women cancer patients – Trial protocol of a randomised controlled trial

AimsThis study will assess the efficacy of digital CBT for insomnia (dCBT-I) compared to sleep hygiene education (SHE) for the management of insomnia in women with cancer. Background30% of patients with cancer meet insomnia diagnostic criteria and this can be detrimental to health outcomes. Insomnia disorder comprises a dissatisfaction with sleep quantity or quality characterized by difficulty initiating sleep, frequent awakenings, or early morning wakening without the ability to return to sleep, at least 3 nights per week, for at least 3 months, causing significant impairment or distress in areas of functioning. MethodsWe will recruit 308 women with a current or prior cancer diagnosis who are currently experiencing insomnia; defined as a score of 16 or less on the Sleep Condition Indicator (SCI). Participants will be randomised to dCBT-I or SHE. dCBT-I will be delivered online via 6 sessions. SHE will be provided in an online format. Assessments of sleep and other related parameters, through validated questionnaires, will be taken at 12 and 24 weeks following intervention. Once 24 week assessments are completed, participants will crossover to the alternate arm (either SHE or dCBT-I) and undergo a final assessment at week 36. OutcomesThe primary outcome will be the mean continuous change in SCI score in the intervention arm compared to the control arm at 24 weeks. Additionally, the proportion of women with an SCI > 16 at 24 weeks will be assessed. Secondary outcomes include fatigue, sleep related quality of life, depression, anxiety, and hot flush interference. RegistrationThis study is registered on ClinicalTrials.gov with number NCT05816460

Characterization of sleep in emerging adults with cystic fibrosis on elexacaftor/tezacaftor/ivacaftor

•Emerging adults (18–25 years of age) have high rates of sleep dysfunction.•CFTR dysfunction has been implicated as a direct cause of sleep disorders.•Elexacaftor/tezacaftor/ivacaftor may improve sleep in emerging adults with CF.•Clinical practice guidelines are needed for sleep disturbances in people with CF. Sleep disturbances are common among youth and adults with cystic fibrosis (CF). Prior to the availability of the most highly effective modulator therapy, elexacaftor/tezacaftor/ivacaftor, 90% of patients with CF identified a need for support to improve sleep quality [[1]Sadicario J.S. Islam L. Bostetter A. Chaudary N. Identifying patient priorities for psychosocial support in an adult cystic fibrosis clinic.Pediatr Pulmonol. 2019; 54: 421PubMed Google Scholar]. In the post elexacaftor/tezacaftor/ivacaftor era, 77% of CF program directors in the United States agreed that sleep disorders are a problem in CF; however, only 10% of programs reported regularly conducting routine, formal sleep screening [[2]Thomas C.S. Brown R.F. Sleep screening for cystic fibrosis patients: a survey of cystic fibrosis programs.Pediatr Pulmonol. 2020; 55: 3358-3363Crossref Scopus (3) Google Scholar]. For adults with CF, studies have reported increased sleep disordered breathing [[3]Shakkottai A. Nasr S.Z. Hassan F. Irani S. O'Brien L.M. Chervin R.D. Sleep-disordered breathing in cystic fibrosis.Sleep Med. 2020; 74: 57-65Crossref Scopus (6) Google Scholar,[4]Reiter J. Gileles-Hillel A. Cohen-Cymberknoh M. et al.Sleep disorders in cystic fibrosis: a systematic review and meta-analysis.Sleep Med Rev. 2020; 51101279Crossref Scopus (21) Google Scholar], a delayed circadian rhythm [[5]Jensen J.L. Jones C.R. Kartsonaki C. Packer K.A. Adler F.R. Liou T.G. Sleep phase delay in cystic fibrosis: a potential new manifestation of cystic fibrosis transmembrane regulator dysfunction.Chest. 2017; 152: 386-393Abstract Full Text Full Text PDF PubMed Scopus (18) Google Scholar], increased symptoms of restless legs syndrome [[6]Jurisch P. Gall H. Richter M.J. et al.Increased frequency of the restless legs syndrome in adults with cystic fibrosis.Respir Med. 2019; 151: 8-10Abstract Full Text Full Text PDF Scopus (4) Google Scholar,[7]Mulette P. Ravoninjatovo B. Guguen C. et al.Insomnia in adults with cystic fibrosis: strong association with anxiety/depression and impaired quality of life.BMC Pulm Med. 2021; 21: 108Crossref Scopus (2) Google Scholar], and insomnia [[7]Mulette P. Ravoninjatovo B. Guguen C. et al.Insomnia in adults with cystic fibrosis: strong association with anxiety/depression and impaired quality of life.BMC Pulm Med. 2021; 21: 108Crossref Scopus (2) Google Scholar]. Sleep has been associated with health-related quality of life (HRQOL) outcomes, including physical, mental, and social health in children [[8]Vandeleur M. Walter L.M. Armstrong D.S. Robinson P. Nixon G.M. Horne R.S.C. Quality of life and mood in children with cystic fibrosis: associations with sleep quality.J Cyst Fibros. 2018; 17: 811-820Abstract Full Text Full Text PDF PubMed Scopus (30) Google Scholar,[9]McMurray J. Widger K. Stephenson A.L. Stremler R. Actigraphic and patient and family reported sleep outcomes in children and youth with cystic fibrosis: a systematic review.J Cyst Fibros. 2022; 21: e49-e82Abstract Full Text Full Text PDF Scopus (0) Google Scholar] and adults [[7]Mulette P. Ravoninjatovo B. Guguen C. et al.Insomnia in adults with cystic fibrosis: strong association with anxiety/depression and impaired quality of life.BMC Pulm Med. 2021; 21: 108Crossref Scopus (2) Google Scholar,[10]Forte G.C. Barni G.C. Perin C. Casarotto F.C. Fagondes S.C. Dalcin Pde T. Relationship between clinical variables and health-related quality of life in young adult subjects with cystic fibrosis.Respir Care. 2015; 60: 1459-1468Crossref PubMed Scopus (12) Google Scholar,[11]Íscar-Urrutia M. Madrid-Carbajal C.J. Rubinos-Cuadrado G. et al.Objective and subjective sleep efficiency in adult patients with cystic fibrosis and impact on quality of life.Lung. 2018; 196: 761-767Crossref Scopus (7) Google Scholar]. Factors associated with sleep disturbances include mucus, reflux, cough, anxiety, depression, and pain [[4]Reiter J. Gileles-Hillel A. Cohen-Cymberknoh M. et al.Sleep disorders in cystic fibrosis: a systematic review and meta-analysis.Sleep Med Rev. 2020; 51101279Crossref Scopus (21) Google Scholar], with self-reported medical marijuana used by >50% of patients with CF for insomnia [[12]Stephen M.J. Chowdhury J. Tejada L.A. Zanni R. Hadjiliadis D. Use of medical marijuana in cystic fibrosis patients.Complement Med Ther. 2020; 20: 323Crossref PubMed Scopus (6) Google Scholar]. CF transmembrane conductance regulator (CFTR) protein is found in the retina and anterior hypothalamus and CFTR dysfunction has been implicated as a cause of sleep dysfunction, with evidence to suggest the CFTR gene may impact regulation of circadian rhythms [[13]Louis M. Staiano P. Micalo L. Chaudary N. Cystic fibrosis and sleep circadian rhythms.Pulm Ther. 2022; 8: 139-147Crossref Scopus (0) Google Scholar]. Use of elexacaftor/tezacaftor/ivacaftor may have a direct impact on sleep beyond the well described benefits of decreased respiratory symptoms including improvements in forced expiratory volume (FEV1) and reductions in pulmonary exacerbations [[14]Graeber S.Y. Vitzthum C. Pallenberg S.T. et al.Effects of elexacaftor/tezacaftor/ivacaftor therapy on CFTR function in patients with cystic fibrosis and one or two F508del alleles.Am J Respir Crit Care Med. 2022; 205: 540-549Crossref PubMed Google Scholar]. One study reported improvements in sleep quality in children and adults taking ivacaftor [[15]McCormick J. Cho D.Y. Lampkin B. et al.Ivacaftor improves rhinologic, psychologic, and sleep-related quality of life in G551D cystic fibrosis patients.Int Forum Allergy Rhinol. 2019; 9: 292-297Crossref PubMed Scopus (34) Google Scholar]. Emerging adulthood (18 to 25 years of age) is a distinct and critical developmental period characterized by identity development, a stage in which young people explore questions of who they are and who they would like to be [[16]Potterton R. Austin A. Robinson L. Webb H. Allen K.L. Schmidt U. Identity development and social-emotional disorders during adolescence and emerging adulthood: a systematic review and meta-analysis.J Youth Adolesc. 2022; 51: 16-29Crossref Scopus (3) Google Scholar]. In addition to identity formation, emerging adults are also exploring and committing to complex choices about education, work, and relationships [[17]Arnett J.J. Emerging adulthood. a theory of development from the late teens through the twenties.Am Psychol. 2000; 55: 469-480Crossref PubMed Scopus (9003) Google Scholar]. Emerging adults with CF must navigate these significant life changes while simultaneously transitioning to independently managing their complex chronic illness [[18]Skedgell K.K. Cao V.T. Gallagher K.A. Anderson B.J. Hilliard M.E. Defining features of diabetes resilience in emerging adults with type 1 diabetes.Pediatr Diabetes. 2021; 22: 345-353Crossref Scopus (6) Google Scholar]. Sleep is also unique among emerging adults, with higher rates of insufficient sleep duration, poor quality sleep, and delayed circadian rhythms [[19]Nicholson L. Bohnert A.M. Crowley S.J. A developmental perspective on sleep consistency: preschool age through emerging adulthood.Behav Sleep Med. 2023; 21: 97-116Crossref Scopus (3) Google Scholar]. We report characterization of patient perspectives on sleep and daytime functioning in emerging adults with CF on elexacaftor/tezacaftor/ivacaftor. This cross-sectional characterization study used an online survey. People with CF (pwCF) ages 18 to 25 years inclusive, English speaking, and currently stable on elexacaftor/tezacaftor/ivacaftor for FDA-approved indications and receiving FDA-approved dosing were recruited from National Jewish Health. Exclusion criteria included pulmonary exacerbation (≥10% decline in percent predicted FEV1 and/or use of systemic antibiotics and/or use of systemic steroids) and/or hospitalization in past month, transplant recipient, diagnosed significant mental health disorder (e.g., schizophrenia, bipolar, PTSD) known to interfere with sleep, and requirement of guardian to support activities of daily living. Participants aged 18 to 25 years inclusive and English speaking without CF (controls) were recruited through peer nomination. Exclusion criteria included a diagnosed chronic illness with daily therapies/medications known to interfere with sleep (e.g., diabetes, hypertension, asthma, GERD), or a diagnosed significant mental health disorder known to interfere with sleep. Sleep. Ten items from validated measures were used to screen for the presence and frequency of symptoms of sleep disordered breathing (snoring, apnea, tired/sleepy during day) [[20]Manzar M.D. Hameed U.A. Alqahtani M. et al.Obstructive sleep apnea screening in young people: psychometric validation of a shortened version of the STOP-BANG questionnaire using categorical data methods.Ann Thorac Med. 2020; 15: 215-222Crossref Scopus (2) Google Scholar], restless legs syndrome [[21]Ferri R. Lanuzza B. Cosentino F.I. et al.A single question for the rapid screening of restless legs syndrome in the neurological clinical practice.Eur J Neurol. 2007; 14: 1016-1021Crossref PubMed Scopus (96) Google Scholar,[22]Fulda S. Allen R.P. Earley C.J. et al.We need to do better: a systematic review and meta-analysis of diagnostic test accuracy of restless legs syndrome screening instruments.Sleep Med Rev. 2021; 58101461Crossref Scopus (10) Google Scholar], and parasomnias (sleep walking/sleep terrors) [[23]Meltzer L.J. Brimeyer C. Russell K. et al.The children's report of sleep patterns: validity and reliability of the sleep hygiene index and sleep disturbance scale in adolescents.Sleep Med. 2014; 15: 1500-1507Crossref PubMed Scopus (31) Google Scholar]. Participants were asked about use of over-the-counter (OTC) sleep aids, melatonin, or marijuana/CBD to facilitate sleep. If endorsed, participants were asked the frequency of use (every night, several nights per week, several nights per month, once a month, less than once a month). PwCF were asked 7 questions about their sleep now, compared to before starting elexacaftor/tezacaftor/ivacaftor. Health-Related Quality of Life (HRQOL). Patient Reported Outcome Measurement Information System (PROMIS®) short forms (4 items each) were used to evaluate HRQOL: Sleep Disturbance, Sleep Related Impairment, Depression, Anxiety, Emotional Support, Informational Support, and Pain Interference [24Buysse D.J. Yu L. Moul D.E. et al.Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments.Sleep. 2010; 33: 781-792Crossref PubMed Scopus (468) Google Scholar, 25Cella D. Riley W. Stone A. et al.The patient-reported outcomes measurement information system (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008.J Clin Epidemiol. 2010; 63: 1179-1194Abstract Full Text Full Text PDF PubMed Scopus (2800) Google Scholar, 26Pilkonis P.A. Choi S.W. Reise S.P. Stover A.M. Riley W.T. Cella D. Item banks for measuring emotional distress from the patient-reported outcomes measurement information system (PROMIS(R)): depression, anxiety, and anger.Assessment. 2011; 18: 263-283Crossref PubMed Scopus (1165) Google Scholar]. Raw scores were converted to T-scores (mean=50, SD=10) using www.assessmentcenter.net. Demographic Information. Participants self-reported demographic variables. Clinical Data Capture. The electronic medical record was reviewed to collect health information on pwCF, including CF mutations, CF complications, comorbidities, and medications. Descriptive statistics were used to describe participant characteristics and changes in sleep since starting elexacaftor/tezacaftor/ivacaftor. Chi-square analyses were used to compare the percent of pwCF and Control participants on categorical variables. One-way ANOVA was used to compare group differences on continuous HRQOL variables, with Cohen's d effect sizes to examine the magnitude of difference [small=0.2, medium=0.5, large=0.8] [[27]Cohen J. Statistical power analysis for the behavioral sciences.2nd ed. Lawrence Erlbaum Associates, Mahwah, NJ1988Google Scholar]. Pearson correlation was used to examine the association between sleep and HRQOL measures. Continuous variables were normally distributed and free from outliers. Study participants included 34 pwCF and 42 controls. Demographic characteristics are shown in Table 1. Overall, study participants ranged in age from 18 to 25 years (M±SD 23.2 ± 1.9 years), 52.6% were female (n = 40), 85.1% White (n = 63), and 14.5% Hispanic (n = 11). PwCF had a mean BMI of 22.6 ± 3.4 (range 16.0 to 34.1) and a mean FEV1% predicted of 92.3 ± 21.9 (range 36.6 to 128.0). CF characteristics were similar to the general population of pwCF [[28]Cystic Fibrosis Foundation Patient Registry 2021 Annual Data Report Bethesda, Maryland ©2022 Cystic Fibrosis Foundation.Google Scholar] (Table 1).Table 1Characterization of study participants by group [percent (n) unless otherwise stated].CF Group (n = 34)Control Group (n = 42)Test statisticPDemographic CharacteristicsMean Age ± SD22.8 ± 1.923.5 ± 1.9t(74) = −1.640.11GenderX2(2) = 1.290.53 Male44.1 (15)47.6 (20) Female52.9 (18)52.4 (22) Other2.9 (1)–RaceX2(3) = 7.030.07 White97.0 (32)75.3 (31) Black–9.8 (4) Asian–4.9 (2) Multi-racial/Other3.0 (1)9.8 (4)EthnicityX2(1) = 0.370.55 Hispanic88.2 (30)83.3 (35) Non-Hispanic11.8 (4)16.7 (7)Currently WorkingX2(2) = 1.480.48 Full-time52.9 (18)66.7 (28) Part-time20.6 (7)14.3 (6) Not working26.5 (9)19.0 (8)Attending SchoolX2(2) = 5.590.06 Full-time26.5 (9)31.0 (13) Part-time2.9 (1)19.0 (8) Not attending school70.6 (24)50.0 (21)Partner StatusX2(2) = 3.450.18 Single44.1 (15)59.5 (25) Married20.6 (7)7.1 (3) Partnered35.3 (12)33.3 (14)ChildrenX2(1) = 1.560.21 No91.2 (31)97.6 (41) Yes8.8 (3)2.4 (1)Living SituationX2(1) = 0.640.42 Home with parent(s)/guardian(s)29.4 (10)21.4 (9) Independently (including college)70.6 (24)78.6 (33)CF Mutations–– F508del94.1 (32)– G551D8.8 (3)– 1898 + 1G→T5.9 (2)–CF Complications–– Pancreatic insufficiency100.0 (34)– Diabetes44.1 (15)– Impaired glucose tolerance44.1 (15)– Osteopenia38.2 (13)– Non-cirrhosis liver disease29.4 (10)– Arthritis20.6 (7)–Comorbidities–– Chronic sinusitis94.1 (32)– Asthma82.4 (28)– GERD58.8 (20)– Depression44.1 (15)– Anxiety32.4 (11)– Hypertension14.7 (5)–Medications–– Nasal steroids38.2 (13)– Monteleukast32.4 (11)– OTC antihistamine32.4 (11)– SSRI17.6 (6)– Sleep prescription*8.8 (3)–Non-Prescription Sleep AidsOTC Sleep AidX2 = 0.740.39 No73.5 (25)64.3 (27) Yes26.5 (9)35.7 (15)Frequency OTC Sleep AidX2 = 4.560.10 Several nights per week22.2 (2)6.7 (1) At least once a month66.7 (6)40.0 (6) Less than once a month11.1 (1)53.3 (8)Melatonin UseX2 = 0.630.43 No70.6 (24)61.9 (26) Yes29.4 (10)38.1 (16)Frequency Melatonin UseX2 = 2.090.35 Several nights per week10.0 (1)18.8 (3) At least once a month30.0 (3)50.0 (8) Less than once a month60.0 (6)31.3 (5)Marijuana/CBD Use for SleepX2 = 1.810.18 No64.7 (22)78.6 (33) Yes35.3 (12)21.4 (9)Frequency Marijuana/CBD UseX2 = 3.860.15 Several nights per week75.0 (9)44.4 (4) At least once a month16.7 (2)55.6 (5) Less than once a month8.3 (1)0.0 (0)*Trazodone, clonazepam, amitriptyline. Open table in a new tab *Trazodone, clonazepam, amitriptyline. Snoring was more common among controls (pwCF=5.9%, controls=23.8%), X2(1)=4.54, p = 0.03, with no group difference in observed apnea frequency (pwCF=5.9%, controls=2.4%), X2(1)=0.61, p = 0.44. More pwCF reported daytime fatigue/sleepiness (pwCF=50.0%, controls=19.0%), X2(1)=8.16, p = 0.004. Although not significant, more pwCF reported symptoms of restless leg syndrome (pwCF=38.2%, controls=26.2%), X2(1)=1.26, p = 0.26, and parasomnias (sleep walking/sleep terrors) (pwCF=47.1%, controls=33.3%), X2(1)=1.48, p = 0.22. Although not significant, more control participants used OTC sleep aids (pwCF=26.5%, controls=35.7%) and melatonin (pwCF=29.4%, controls=38.1%) to facilitate sleep (Table 1). More pwCF used marijuana/CBD (pwCF=35.5%, controls=21.4%) to facilitate sleep, with 75% of pwCF using marijuana/CBD for sleep several nights per week (vs. 44.4% of controls). Notably, although fewer pwCF used OTC sleep aids, their use was more frequent than controls. Similarly, although fewer pwCF used melatonin, they used significantly higher doses (pwCF=8.3 ± 5.8 mg, controls=3.8 ± 2.9 mg), t(24)=2.69, p = 0.01. Eighty-eight to 97% of pwCF reported either no change or improvements in sleep since starting elexacaftor/tezacaftor/ivacaftor (Fig. 1). The most notable change was a decrease in the frequency of medications to facilitate sleep, with almost a third of pwCF reporting improvements. Open ended responses also noted “feeling less mucus in my lungs,” “needing less sleep,” and “wake up from coughing better.” Since starting elexacaftor/tezacaftor/ivacaftor, 29% (n = 10) of pwCF reported no change in sleep, 35% (n = 12) reported ≥1 area of improvement, and no worsening symptoms, 18% (n = 6) reported ≥1 area of improvement and 1 worsening symptom, and 18% (n = 6) reported ≥1 area of sleep getting worse, and no improvements. As seen in Table 2, compared to controls, pwCF reported significantly greater sleep disturbances (d = 0.46) and more pain (d = 0.66). Although not statistically significant, small to medium effect sizes highlighted more sleep-related daytime impairment (d = 0.35) and less social support in terms of the availability of helpful information or advice (d = -0.37) in pwCF compared to controls.Table 2PROMIS health-related quality of life (HRQOL) mean (SD) T-scores by group.CF Group (n = 34)Control Group (n = 42)FPCohen's dSleep Disturbance51.2 (6.0)48.2 (7.0)3.910.050.46Sleep-Related Impairment55.2 (7.4)52.5 (8.1)2.240.140.35Anxiety56.5 (9.5)54.9 (8.7)0.600.440.18Depressive Symptoms51.8 (9.7)51.1 (9.1)0.100.760.07Emotional Support55.6 (9.1)55.7 (8.2)0.010.94−0.01Informational Support56.0 (10.5)59.3 (7.1)2.760.10−0.37Pain49.8 (8.7)44.9 (5.9)8.730.0040.66 Open table in a new tab For pwCF, greater sleep disturbances were associated with increased anxiety (r = 0.58, p<0.001) and depressive symptoms (r = 0.50, p = 0.002), lower emotional support (r = -0.35, p = 0.04) and information support (r = -0.39, p = 0.02), and more pain (r = 0.32, p = 0.06). Greater sleep-related impairment was associated with increased anxiety (r = 0.59, p<0.001) and depressive symptoms (r = 0.49, p = 0.003), and lower information support (r = -0.36, p = 0.04). For control participants, greater sleep disturbances were associated with increased anxiety (r = 0.46, p = 0.02) and depressive symptoms (r = 0.44, p = 0.003). Greater sleep-related impairment was associated with increased anxiety (r = 0.46, p = 0.02) and depressive symptoms (r = 0.64, p<0.001). This study highlights that elexacaftor/tezacaftor/ivacaftor may improve sleep in some emerging adults with CF. Despite this improvement, sleep remains a significant concern, with pwCF more frequently using sleep aids, reporting poorer quality sleep, and more impacts on quality of life than age-matched controls. Due to the small sample size, many of the group comparisons were not significantly different, however, the results were clinically meaningful and may be statistically significant if repeated in a larger sample. Study limitations also include the correlational study design, self-selection bias, recall bias potentially influenced by time on elexacaftor/tezacaftor/ivacaftor (i.e., questions only asked after participants were already on treatment), and overall transformative health improvements frequently experienced by people taking this therapy, as well as the lack of data on control participant BMI that may be related to sleep disordered breathing. As a preliminary characterization of this sample, further research is needed that will objectively characterize sleep with actigraphy and polysomnography, and further explore the relationship between sleep disturbances and HRQOL among pwCF. Future studies should also include information about symptoms of daytime sleepiness, alcohol use, exercise, caffeine consumption, and screen time. Further investigation of the impact of elexacaftor/tezacaftor/ivacaftor on sleep is warranted, including a comparison with pwCF who are not eligible for CFTR modulator therapy. Together this knowledge can facilitate development of clinical practice guidelines for the screening and treatment of sleep disturbances in pwCF.

Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial

BackgroundCognitive Behavioral Therapy for Insomnia (CBTi) is recommended as first-line treatment for insomnia, yet patient access to CBTi is limited. Self-help CBTi could increase patient access. Self-help CBTI with provider sup]port is more effective and is preferred by patients. Self-help CBTi has not been evaluated in veterans; a population with greater medical and mental health morbidity and more severe sleep difficulties than non-veterans. Moreover, those with mental health conditions have been largely excluded from prior CBTi self-help trials. Stablishing the efficacy of provider-supported Self-help CBTi is an important first step for expanding veteran access to CBTi. MethodsIn a 2-armed randomized controlled trial, a provider-supported self-help CBTi (Tele-Self CBTi) is compared to Health Education for improving insomnia severity (primary outcome) among treatment-seeking veterans with insomnia disorder. Tele-Self CBTi is comprised of two treatment components: self-help CBTi via a professionally designed manual developed using an iterative process of expert review and patient input; and 6 telephone-based support sessions lasting >20 min. Outcomes are assessed at baseline, 8 weeks, and 6 months after baseline. The primary outcome, insomnia severity, is measured using the Insomnia Severity Index. Secondary outcomes include self-reported and actigraphy-assessed sleep, fatigue, depression symptoms, and sleep-related quality of life. ConclusionInnovative approaches are essential to improving overall health among veterans; a population with highly prevalent insomnia disorder. If effective, Tele-Self CBTi may bridge the gap between unavailable resources and high demand for CBTi and serve as the entry level intervention in a stepped model of care. Clinical trials.gov identifierNCT03727438

Sleep patterns in patients treated for non-secreting intra- and parasellar tumors: A self-report case-control study.

In this study we evaluate sleep patterns of patients treated for non-secreting intra- and parasellar tumors and age- and sex-matched healthy controls. We conducted a self-report cross-sectional case-control study with 104 patients treated for non-secreting intra- and parasellar tumors and 1800 healthy controls in an 1:8 matching. All subjects answered the Munich ChronoType Questionnaire, whereas patients were provided the Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Short-Form 36 Health survey, the Beck Depression Inventory and the State-Trait Anxiety Inventory additionally. Patients treated for non-secreting intra- and parasellar tumors go to bed earlier, fall asleep earlier, need less time to prepare to sleep but also to get up. Additionally, they lie and sleep longer. The subgroup analysis showed that patients with secondary adrenal insufficiency compared to controls experienced shorter daily light exposure and longer sleep latency. Higher hydrocortisone dose (>20mg) was associated with worse score in global, physical and mental health, shorter time to prepare to sleep, earlier sleep onset and longer sleep duration. Our study shows that patients treated for non-secreting intra- and parasellar tumors, even if successfully treated, experience altered sleep patterns compared to controls. We suggest that managing clinicians should enlighten these possible sleep alterations to their patients and use specific questionnaires to document sleep disturbances. Additionally, when treating patients surgically, especially by transcranial approach, damaging the suprachiasmatic nucleus should be avoided. Furthermore, circadian hydrocortisone replacement therapy ideally with dual-release hydrocortisone - if possible, in a dose not more than 20mg daily - that resembles physiological cortisol levels more closely may be beneficial and could improve sleep patterns and sleep-related quality of life.

A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the efficacy of Rest-ZZZ formula in healthy participants with occasional sleeplessness

The purpose of this study was to investigate the safety and efficacy of Rest-ZZZ, a natural sleep supplement, in healthy adults without a diagnosed sleep disorder. This randomized, double-blind, placebo-controlled, cross-over study consisted of three 7-day supplementation periods with either Rest-ZZZ, Diphenhydramine (DPH), or Placebo, with a 7-day washout. Twenty-seven participants were randomized to one of three intervention sequences and the Healthy People Sleep Quality Index (HPSQI), Quality of Life (QoL), and Profile of Mood States (POMS) questionnaires were assessed at the beginning and end of each supplementation period. Rest-ZZZ and Placebo showed improvements in sleep-related QoL (p ≤ 0.044) and total mood disturbance (TMD) (p =  ≤ 0.028). Fatigue–Inertia was reduced by all study products (p ≤ 0.031). DPH did not result in any significant improvements on sleep quality parameters. A subgroup analysis of participants ≤ 45 years found enhanced efficacy of Rest-ZZZ and improvement in sleep-related QoL vs. Placebo (p = 0.007), as well as improvements in sleep duration (p = 0.007), sleep debt (p = 0.011), and sleep-related QoL (p = 0.033). DPH supplementation resulted in significant improvement in only sleep debt (p = 0.038). Rest-ZZZ had a safe hematology and chemistry profile. Rest-ZZZ resulted in restful sleep that generated corresponding improvements in sleep-related QoL and overall mood. Rest-ZZZ is an efficacious sleep supplement with a favorable safety profile, particularly in those aged 25–45 years.

787-P: Quality of Life and Psychological Well-Being among Children with Diabetes Using Open-Source Automated Insulin Delivery Systems: Findings from a Global Survey

Background: Open-source automated insulin delivery (AID) systems have shown to be safe and effective in clinical and real-world studies and to increase quality of life (QoL) in adult users. However, there is a lack of evidence on the effect on health-related QoL and general wellbeing in children and their caregivers. Therefore, the aim of this study was to assess the QoL of children and adolescents with diabetes using open-source AID systems using validated measures. Method: In this cross-sectional, population-based global online survey we examined the caregiver-reported QoL and psychological well-being of users and non-users of open-source AID. Validated questionnaires assessed general emotional wellbeing (WHO-5 Well-being Index) , diabetes-specific QoL (Problem Areas in Diabetes Survey - Parent Revised version (PAID-PR) , Pediatric Quality of Life Inventory (PedsQL, diabetes module) and subjective sleep quality (Pittsburgh Sleep Quality Index (PSQI)) . Results: In total 188 caregivers from 27 countries completed at least one questionnaire on behalf of their children, including 132 children with type 1 diabetes using open-source AID (mean age 11.5 (SD 3.5) , 48% female) and 56 children with type 1 diabetes who were non-users at the time of the survey (mean age 10.4 (SD 3.3) , 41% female) . All questionnaire scores showed significant between-group differences with the AID users reporting higher general (WHO-5: p&amp;lt;0.001) , diabetes-related (PAID: p=0.029; PedsQL: p=0.016) and sleep-related QoL (PSQI: p&amp;lt;0.001) . Discussion: The results show the beneficial impact that open-source AID systems have on the QoL and psychological well-being of children and adolescents, and can therefore help to inform academia, regulatory decision- and policymakers about the potential that open-source AID systems hold. Further research is needed to examine the reasons for the differences between the groups. Disclosure C.Knoll: None. K.Raile: Other Relationship; Dexcom, Inc. K.Braune: None. H.Ballhausen: None. J.Schipp: None. T.C.Skinner: None. M.Wäldchen: None. S.O'donnell: None. K.A.Gajewska: None. B.Cleal: None. Funding European Commission's Horizon 2020 Research and Innovation Program under the Marie Skłodowska-Curie Action Research and Innovation Staff Exchange (RISE) (grant agreement number 823902)

Insomnia affects patient-reported outcome in sleep apnea treated with hypoglossal nerve stimulation.

ObjectiveComorbid insomnia may impact outcomes of patients with obstructive sleep apnea (OSA) receiving hypoglossal nerve stimulation with respiratory sensing (HNS) therapy. To examine whether the presence of insomnia measured using the Insomnia Severity Index (ISI) is associated with patient‐reported outcomes and objective OSA measures in patients receiving HNS therapy.MethodsIn this retrospective chart review, patients with an HNS implant and ISI score at follow‐up assessment were categorized as having moderate/severe insomnia or no/subthreshold insomnia. OSA‐related data (Apnea Hypopnea Index, AHI; Oxygen Desaturation Index, ODI), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and overall patient satisfaction was compared between these patient categories. Correlations between ISI scores and each of these variables were examined.ResultsOf the 132 patients, 26% had moderate/severe insomnia at follow‐up assessment. ESS and FOSQ scores were worse in the insomnia group at baseline, follow‐up, and in the change from baseline, but AHI and ODI scores did not differ between patients with and without insomnia. Frequency of overall satisfaction at follow‐up was lower in the insomnia group (58.8% vs. 92.8% with no insomnia, P < .001). Patients with insomnia were more likely to have depression (56% vs. 27% without insomnia, P < .002).ConclusionsInsomnia is associated with worse patient‐reported outcomes of daytime sleepiness and sleep‐related quality of life in patients with OSA receiving HNS therapy. Depression is more prevalent in patients with comorbid insomnia. The ISI may help physicians to address comorbid insomnia and achieve high patient satisfaction and adherence to HNS therapy.Level of Evidence4

Effects of TORS-OSA Surgery on Lower Urinary Tract Symptoms, Overactive Bladder Symptoms, and Nocturia in Male Patients with Obstructive Sleep Apnea/Hypopnea Syndrome

ObjectiveTo determine the presence of lower urinary tract symptoms (LUTS), and overactive bladder (OAB) symptoms in men with obstructive sleep apnea/hypopnea syndrome (OSA) and the effects of transoral robotic surgery (TORS) for the treatment of OSA on these conditions.Materials and MethodsOne hundred twenty-three patients with a diagnosis of OSA were prospectively enrolled. The evaluations of LUTS and OAB symptoms were based on self-administered questionnaires containing international prostate symptom score (IPSS) and OAB symptom score (OABSS), respectively. Men with an OABSS urgency score of ≥2 and sum score of ≥3 were considered to have OAB. The therapeutic outcomes were assessed at baseline, and 12 weeks after TORS-OSA Surgery.ResultsThere were significant differences in IPSS, and OABSS according to OSA severity. After TORS-OSA surgery, significant improvements on OSA severity, daytime quality of life (QoL) and nighttime sleep quality were observed. TORS-OSA surgery was also associated with a statistically significant improvement of LUTS, LUTS QoL score, and OAB symptoms (IPSS 22.1% decrease; IPSS QoL score 21.1% decrease; OABSS17.4% decrease) at post-operative 3 months’ follow-up. The presence of OAB, and severe nocturia was significantly reduced from 22.8% to 11.4% (p=0.001), 5.7% to 0.8% (p=0.031) after TORS-OSA surgery. There were no patients who had acute airway compromise or massive bleeding peri- or post-operatively.ConclusionTORS upper airway surgery could improve LUTS and OAB symptoms on male patients with OSA in addition to improvement of major parameters of sleep study and sleep-related QoL.

The Effect of Adenotonsillectomy on Children's Behavior and Cognitive Performance with Obstructive Sleep Apnea Syndrome: State of the Art.

(1) Background: This systematic review was designed to analyze adenotonsillectomy’s role in treating behavioural disorders and sleep-related quality of life in pediatric OSAS. (2) Methods: Papers that report pre-operative and post-operative outcomes by using the Epworth sleepiness scale, OSA-18, NEPSY, Conners’ rating scale, BRIEF, PSQ-SRBD, PedsQL and CBCL. We performed a comprehensive review of English papers published during the last 20 years regarding behavioural disorders in OSAS patients and adenotonsillectomy. (3) Results: We included 11 studies reporting behavioral outcomes and sleep related quality of life after surgery. We investigated changes in behavior and cognitive outcomes after AT, and we found significant improvements of the scores post-AT in almost all studies. After comparing the AT group and control group, only one study had no difference that reached significance at one year post-AT. In another study, it did not show any significant improvement in terms of all behavioural and cognitive outcomes. The questionnaires on sleep-related quality of life after AT (PSQ-SRBD or ESS or OSA-18 or KOSA) may improve with positive changes in sleep parameters (AHI, ODI and SpO2). Furthermore, there is a significantly higher decrease in OSAS symptoms than the pre-AT baseline score. (4) Conclusion: Future studies should pay more attention to characterizing patient populations as well as rapid surgical treatments through existing criteria.

Effectiveness of Information and Communication Technology (ICT) Interventions in Elderly's Sleep Disturbances: A Systematic Review and Meta-Analysis.

Sleep is a crucial factor for human health and is closely related to quality of life. Sleep disturbances constitute a health problem that should be solved, especially when it affects the elderly. This study aims to examine the effectiveness of information and communication technologies (ICT) interventions in managing sleep disturbances in the elderly. The study used a systematic review of three databases: Ovid-Medline, Ovid-EMBASE, and the Cochrane library database for papers published till 15 April 2021. Two authors independently selected and screened relevant studies based on predefined inclusion criteria. The meta-analysis of randomized controlled trials (RCTs) was carried out using Review Manager 5.4. Two authors independently screened the titles and abstracts of 4297 studies considering both inclusion and exclusion criteria. The complete texts of 47 articles were then evaluated, 31 articles were excluded, and finally, 16 articles were selected. Our meta-analysis showed that the cognitive-behavioral therapy for insomnia (CBT-I) group had a significantly reduced Insomnia Severity Index (ISI) compared to the control group (−4.81 [−5.56, −4.06], p < 0.00001, I2 = 83%) in RCTs, with a significant reduction in ISI (3.47 [1.58, 5.35], p = 0.0003) found in quasi-experimental studies. A significant improvement was found in total sleep time in the CBT-I group compared to the control group (29.24 [15.41, 43.07], p <0.0001) in RCTs, while the CBT-I group showed significantly reduced wake time after sleep onset compared to the control group (−20.50 [−26.60, −14.41], p < 0.00001). In addition, a significant reduction in depression was found in the CBT-I group compared to the control group (−2.11 [−2.85, −1.37], p < 0.00001, I2 = 0%) in RCTs. The quality of life–mental component score (5.75 [1.64, 9.87], p = 0.006, I2 = 0%) and the quality of life–physical component score (5.19 [0.76, 9.62], p = 0.02, I2 = 0%) showed significant improvement in the CBT-I group compared to the control group. ICT interventions showed positive effects on sleep disturbances of the elderly, specifically confirming the positive effect on depression and quality of life as well as the indicators directly related to sleep such as ISI and quality of sleep. Thus, the application of ICT in the healthcare sector will be greater in the future, with changes in the nursing education and practice guidelines so that nurses can play a pivotal role in promoting health behaviors such as sleep-related quality of life and daily activities of the elderly.

Role of yoga therapy in improving digestive health and quality of sleep in an elderly population: A randomized controlled trial

IntroductionConstipation and sleep disturbances commonly affect elderly population results in compromised physical and mental health. Mind-body interventions like yoga not only address the mental and physical health but also promote healthy ageing. This study evaluates the effect of 3 months yoga intervention on the sleep and constipation related quality of life (QoL) among the elderly. Materials and methodsNinety six participants aged between 60 and 75 who did not had any history of yoga practice for past 1 year and having a zubrod score of 0–2 were randomized in to yoga (n = 48) or waitlisted control (n = 48). The yoga group received yoga interventions at a frequency of 3 sessions per week for 3 months. Pittsburg Sleep Quality Index (PSQI) and Patient Assessment of Constipation QoL (PAC-QOL) were used to assess the improvement. Intention to treat analysis method was used to include the drop-out participants. ResultsEighty one participants (Yoga = 48, waitlisted control = 33) completed the study. Wilcoxon's sign rank test has shown that the yoga group had statistically significant changes in most of the parameters in PSQI and PAC-QOL (P ≤ 0.05). Mann Whitney test revealed that yoga group has better improvement in the sleep quality and constipation related QOL (P ≤ 0.05) compared to the controls. DiscussionThe results signify yoga can ease old age related issues like constipation and insomnia. This is encouraging for inclusion of yoga as a daily practice regimen to improve the constipation and sleep related quality of life in elderly population.

Use of polysomnography and home sleep apnea tests for the longitudinal management of obstructive sleep apnea in adults: an American Academy of Sleep Medicine clinical guidance statement.

Obstructive sleep apnea is an important and common disorder with associated health risks. Assuring successful longitudinal management is vital to patient health and sleep-related quality of life. This paper provides guidance from the American Academy of Sleep Medicine (AASM) regarding the use of polysomnography (PSG) and home sleep apnea tests (HSATs) after a diagnosis of obstructive sleep apnea has been established and, in most cases, treatment implemented. The AASM commissioned a task force of five sleep medicine experts. A literature search was conducted to identify studies that included adult patients with OSA who underwent follow-up PSG or an HSAT. The task force developed clinical guidance statements based on a review of these studies and expert opinion. The AASM Board of Directors approved the final clinical guidance statements. The AASM supports the following clinical guidance statements on indications for follow-up PSG and HSAT in adult patients with OSA. 1. Follow-up PSG or HSAT is not recommended for routine reassessment of asymptomatic patients with obstructive sleep apnea on PAP therapy, however, follow-up PSG or HSAT can be used to reassess patients with recurrent or persistent symptoms, despite good PAP adherence. 2. Follow-up PSG or HSAT is recommended to assess response to treatment with non-PAP interventions. 3. Follow-up PSG or HSAT may be used if clinically significant weight gain or loss has occurred since diagnosis of OSA or initiation of its treatment. 4. Follow-up PSG may be used for reassessment of sleep-related hypoxemia and/or sleep-related hypoventilation following initiation of treatment for OSA. 5. Follow-up PSG or HSAT may be used in patients being treated for OSA who develop or have a change in cardiovascular disease. 6. Follow-up PSG may be used in patients with unexplained PAP device-generated data. The ultimate judgment regarding propriety of any specific care must be made by the clinician, in light of the individual circumstances presented by the patient, available diagnostic tools, accessible treatment options and resources.

0665 Bilateral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea

Abstract Introduction Hypoglossal Nerve Stimulation (HGNS) decreases obstructive sleep apnea (OSA) severity by contracting the tongue and decreasing upper airway collapsibility. This study assessed the safety and effectiveness of a new implantable device that delivers bilateral HGNS: the Genio™ system. Methods The BLAST OSA study (BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea), was a prospective, open-label, non-randomized, single arm treatment study conducted at eight centres in three countries (Australia, France, UK). Primary outcomes were the incidence of device-related Serious Adverse Events (SAEs) and change in the Apnea-Hypopnea Index (AHI). The secondary outcome was change in the 4% Oxygen Desaturation Index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring, and device use. Participants were eligible if: 21-75 years old; BMI ≤ 32 kg/m2; obstructive AHI 20-60 events/hr and combined central and mixed AHI &amp;lt; 10 events/hr; no positional OSA; no Complete Concentric Collapse of the soft palate during Drug Induced Sleep Endoscopy; and failed to tolerate or accept Positive Airway Pressure treatments. Results 27 participants were implanted (63% male, aged 55.9±12.0 years, BMI 27.4±3.0 kg/m2). 22 completed the protocol. At 6 months, AHI decreased from 23.7±12.2 to 12.9±10.1 events/hr [p&amp;lt;0.001]; and ODI decreased from 19.1±11.2 to 9.8±6.9 events/hr [p&amp;lt;0.001]. Daytime sleepiness (ESS, p=0.011) and sleep-related quality of life (FOSQ-10, p=0.016) both significantly improved. 91% of participants reported using their device &amp;gt;5 days per week, and 77% used it &amp;gt;5 hours per night. The number of bed partners reporting disruptive snoring decreased from 96% to 35%. No device-related SAE occurred. Conclusion In a targeted population of individuals with moderate-to-severe OSA, the Genio system reduced OSA severity and sleepiness, improved quality of life, and was associated with high adherence and an acceptable safety profile. Support This study trial was funded by Nyxoah S.A. This trial was registered with ClinicalTrials.gov, number NCT03048604.

Isolating the role of time in bed restriction in the treatment of insomnia: a randomized, controlled, dismantling trial comparing sleep restriction therapy with time in bed regularization.

Sleep restriction therapy (SRT) is one of the most effective treatments for insomnia. Restriction of time in bed (TIB) is assumed to be the central mechanism through which SRT improves sleep consolidation and reduces insomnia symptoms. This hypothesis has never been directly tested. We designed a randomized, controlled, dismantling trial in order to isolate the role of TIB restriction in driving both clinical and polysomnographic sleep outcomes. Participants aged 25-55 who met diagnostic criteria for insomnia disorder were block-randomized (1:1) to 4 weeks of SRT or time in bed regularization (TBR), a treatment that involves the prescription of a regular but not reduced TIB. The primary outcome was assessed with the insomnia severity index (ISI) at baseline, 4-, and 12-weeks post-randomization. Secondary outcomes included sleep continuity (assessed via polysomnography, actigraphy, and diary) and quality of life. We performed intention-to-treat analyses using linear mixed models. Fifty-six participants (39 females, mean age = 40.78 ± 9.08) were assigned to SRT (n = 27) or TBR (n = 29). Daily monitoring of sleep via diaries and actigraphy confirmed large group differences in TIB (d range = 1.63-1.98). At 4-weeks post-randomization, the adjusted mean difference for the ISI was -4.49 (d = -1.40) and -4.35 at 12 weeks (d = -1.36), indicating that the SRT group reported reduced insomnia severity relative to TBR. Robust treatment effects in favor of SRT were also found for objective and self-reported sleep continuity variables (d range = 0.40-0.92) and sleep-related quality of life (d = 1.29). For the first time, we demonstrate that TIB restriction is superior to the regularization of TIB on its own. Our results underscore the centrality of the restriction component in reducing insomnia symptoms and consolidating sleep.

Effectiveness of respiratory muscle training for patients with obstructive sleep apnea: A protocol of systematic review and meta-analysis.

Background:This study will evaluate the effectiveness and safety of respiratory muscle training (RMT) for patients with obstructive sleep apnea (OSA).Methods:Randomized controlled trials will be retrieved through electronic database searches from MEDLINE, EMBASE, Cochrane Library, CINAHL, Scopus, CBM, and CNKI from the beginning to the present. All electronic databases will be searched without any language limitation. Two researchers will independently select studies, collect data, and assess study quality, respectively. RevMan 5.3 software will be used for statistical analysis.Results:The primary outcome is severity of OSA, as measured by polysomnography or any relevant tools. The secondary outcomes are hypopnea index, apnea index, respiratory event index, respiratory disturbance index, sleep-related quality of life, and any expected or unexpected adverse events.Conclusion:The results of this study will summarize current evidence of RMT for the treatment of patients with OSA.Systematic review registration:INPLASY202040051.

Brief digital sleep questionnaire powered by machine learning prediction models identifies common sleep disorders

IntroductionWe developed and validated an abbreviated Digital Sleep Questionnaire (DSQ) to identify common societal sleep disturbances including insomnia, delayed sleep phase syndrome (DSPS), insufficient sleep syndrome (ISS), and risk for obstructive sleep apnea (OSA). MethodsThe DSQ was administered to 3799 community volunteers, of which 2113 were eligible and consented to the study. Of those, 247 were interviewed by expert sleep physicians, who diagnosed ≤2 sleep disorders. Machine Learning (ML) trained and validated separate models for each diagnosis. Regularized linear models generated 15–200 features to optimize diagnostic prediction. Models were trained with five-fold cross-validation (repeated five times), followed by robust validation testing. ElasticNet models were used to classify true positives and negatives; bootstrapping optimized probability thresholds to generate sensitivities, specificities, accuracies, and area under the receiver operating curve (AUC). ResultsCompared to reference subgroups, physician-diagnosed sleep disorders were marked by DSQ evidence of sleeplessness (insomnia, DSPS, OSA), sleep debt (DSPS, ISS), airway obstruction during sleep (OSA), blunted circadian variability in alertness (DSPS), sleepiness (DSPS and ISS), increased alertness (insomnia) and global impairment in sleep-related quality of life (all sleep disorders). ElasticNet models validated each diagnosis with high sensitivity (80–83%), acceptable specificity (63–69%), high AUC (0.80–0.85) and good accuracy (agreement with physician diagnoses, 68–73%). DiscussionA brief DSQ readily engaged and efficiently screened a large population for common sleep disorders. Powered by ML, the DSQ can accurately classify sleep disturbances, demonstrating the potential for improving the sleep, health, productivity and safety of populations.

Primary care treatment of insomnia: study protocol for a pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy to sleep hygiene (the HABIT trial)

IntroductionInsomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction...