Functional Outcomes Of Sleep Questionnaire Research Articles

Gender differences in oral appliance treatment of obstructive sleep apnea.

Although overall success rates for treating obstructive sleep apnea (OSA) with an oral appliance (OA) are high, they are significantly higher among females. To verify published data, the study's purpose was to evaluate a participant sample after one year of OA use. The primary outcome was treatment response, with responders defined as having an apnea-hypopnea index (AHI) < 10 at follow-up and/or reduced by ≥50% of baseline. Secondary measures were from standardized questionnaires. A sample of 314 participants, predominately with moderate-to-severe OSA, were enrolled and instructed to use an OA every night. At baseline and one-year follow-up, polygraphic recordings and questionnaires, including sleepiness (measured using the Epworth sleepiness scale) and quality-of-life (measured using the Functional Outcomes of Sleep Questionnaire), were collected. Among the 314 participants, 192 completed the one-year evaluation: 51 females (27%) and 141 males (73%). Overall, OA treatment resulted in 78% and 77% responders among females and males, respectively. Neither the difference in improvement nor the absolute change in AHI differed significantly based on gender, at any OSA severity level. There were no significant gender differences in sleepiness or quality of life. Treatment-related adverse reactions were more common among females. Both females and males with OSA respond well to OA therapy, with nonsignificant gender differences in outcomes. Thus, the hypothesis that females respond better to OA treatment is rejected.

The short Thai version of functional outcomes of sleep questionnaire (FOSQ-10T): reliability and validity in patients with sleep-disordered breathing.

The study is to evaluate reliability and validity of the short Thai version of Functional Outcome of Sleep Questionnaire (FOSQ-10T), in patients with sleep disordered breathing (SDB). Inclusion criteria were Thai patients with SDB age ≥ 18years old who had polysomnography results available. Exclusion criteria were patients unable to complete questionnaire for any reason, patients with a history of continuous antidepressant or alcohol use, and underlying disorders including unstable cardiovascular, pulmonary, or neurological conditions. All participants were asked to complete the FOSQ-10T and Epworth sleepiness scales (ESS). Of these, 38 patients were required to retake FOSQ-10T at 2-4weeks later to assess test-retest reliability, and 19 OSA patients treated with CPAP were asked to do so at 4weeks following therapy to assess questionnaire's responsiveness to treatment. There were 42 participants (24 men, 18 women), with a mean age of 48.3years. The internal consistency of the FOSQ-10T was good, as indicated by Cronbach's alpha coefficient of 0.85. The test-retest reliability was good, as indicated by intraclass correlation coefficient of 0.77. The correlation between the FOSQ-10T and ESS scores (concurrent validity) was moderate (r = - 0.41). The scores of FOSQ-10T significantly increased after receiving adequate CPAP therapy, showing an excellent responsiveness to treatment. However, there was no significant association between FOSQ-10T scores and OSA severity measured by apnea-hypopnea index. The FOSQ-10T has good reliability and validity to use as a tool to assess QOL in Thai patients with SDB. It is convenient and potentially useful in both clinical and research settings.

Impacts of conservative treatment on the clinical manifestations of obstructive sleep apnea-systematic review and meta-analysis.

Obstructive sleep apnea (OSA) is a chronic disease with a high populational prevalence that is characterized as airway closure during sleep. Treatment is multidisciplinary and varies according to each case. Continuous positive airway pressure (CPAP), oral appliances, and surgery are the primary therapeutic options. Non-invasive conservative treatments such as sleep hygiene, positional therapy, physical exercises, and weight loss aim to reduce the worsening of the disease while being complementary to the invasive primary treatment. To analyze the impact of non-invasive conservative therapies on the clinical manifestations of OSA syndrome (OSA), compared with other interventions. This was a systematic review with meta-analysis. The searches were performed without filters for the time period, type of publication, or language. Randomized clinical trials on subjects over 18years of age diagnosed with untreated OSA were included. Responses to non-invasive conservative treatment were compared with responses to the primary intervention. Primary outcomes were assessed using the Epworth Sleepiness Scale and/or Functional Outcomes of Sleep Questionnaire (FOSQ). A total of eight studies were included in the review. The heterogeneity of the effect was estimated at 89.77%. Six studies compared conservative treatment with CPAP, one with oral appliances, and one with oropharyngeal exercises. Using the Epworth Sleepiness Scale measurements, the standardized difference in the estimated means, based on the random-effects model, was 0.457 (95% CI (1.082 to 0.169)) and the mean result did not differ significantly from zero (z = 1.43; p = 0.153). The conservative therapies assessed in this study improved the subjective quality of sleep, although the post-treatment ESE scores did not show significant results. The reduction in AHI and better outcomes in the evaluated domains, as well as in cognition and mood, were superior in the groups that received CPAP and IOD. The most commonly used treatments of choice for OSA are invasive, including the use of CPAP, oral appliances, and surgeries, being the most utilized options. This study demonstrated that non-invasive conservative treatments, such as sleep hygiene, yield results as effective as invasive treatments. Further studies are needed to confirm this result and to predict whether invasive treatment can be used as the primary treatment or only as a supplement.

Psychometric evaluation of the Brazilian-Portuguese version of the Functional Outcome of Sleep Questionnaire 10 (FOSQ10) in patients with obstructive apnea

Psychometric evaluation of the Brazilian-Portuguese version of the Functional Outcome of Sleep Questionnaire 10 (FOSQ10) in patients with obstructive apnea

Telemedicine management of obstructive sleep apnea disorder in China: a randomized, controlled, non-inferiority trial.

Previous studies assessed different components of telemedicine management pathway for OSA instead of the whole pathway. This randomized, controlled, and non-inferiority trial aimed to assess whether telemedicine management is clinically inferior to in-person care in China. Adults suspected of OSA were randomized to telemedicine (web-based questionnaires, self-administered home sleep apnea test [HSAT], automatically adjusting positive airway pressure [APAP], and video-conference visits) or in-person management (paper questionnaires, in-person HSAT set-up, APAP, and face-to-face visits). Participants with an apnea-hypopnea index (AHI) ≥ 15 events/hour received APAP for 3months. The non-inferiority analysis was based on the change in Functional Outcomes of Sleep Questionnaire (FOSQ) score and APAP adherence. Cost-effectiveness analysis was performed. In the modified intent-to-treat analysis set (n = 111 telemedicine, 111 in-person), FOSQ scores improved 1.73 (95% confidence interval [CI], 1.31-2.14) points with telemedicine and 2.05 (1.64-2.46) points with in-person care. The lower bound of the one-sided 95% non-inferiority CI for the difference in change between groups of - 0.812 was larger than the non-inferiority threshold of - 1. APAP adherence at 3months was 243.3 (223.1-263.5) minutes/night for telemedicine and 241.6 (221.3-261.8) minutes/night for in-person care. The lower bound of the one-sided 95% non-inferiority CI of - 22.2min/night was higher than the non-inferiority delta of - 45min/night. Telemedicine had lower total costs than in-person management (CNY 1482.7 ± 377.2 vs. 1912.6 ± 681.3; p < 0.0001), driven by patient costs, but no significant difference in QALYs. Functional outcomes and adherence were not clinically inferior in patients managed by a comprehensive telemedicine approach compared to those receiving in-person care in China. https://www.chictr.org.cn , Registration number ChiCTR2000030546. Retrospectively registered on March 06, 2020.

Follow-up assessment of sleep-related symptoms in patients aftertreatment forcancer: responses to continuous positive airway pressure treatment for co-morbid obstructive sleep apnoea.

To assess changes in sleep-related symptoms in patients withbreastcancer, endometrial cancer and melanoma previously examined for sleep-related symptoms and the presence of PSG (polysomnography)-determined OSA, ≥ 3years post-treatment; and to evaluate how CPAP treatment affects sleep-related symptoms in patients previously diagnosed with OSA. Patients initially recruited from breast cancer, endometrial cancer, and melanoma follow-up clinics at Westmead Hospital (Sydney, Australia) participated in this questionnaire-based study. Demographic and change in cancer status data were collected at follow-up. Patients completed the Pittsburgh Sleep Quality Index [poor sleep quality, PSQITOTAL ≥ 5au], Insomnia Severity Index, Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire; with ΔPSQITOTAL ≥ 3au indicating a clinically meaningful change in sleep quality over follow-up. PSG-determined OSA was confirmed using the apnoea-hypopnoea index. CPAP compliance was determinedvia self-report (CPAP compliant, CPAP; not compliant, non-CPAP). Logistic regression models determined if changes in cancer status, AHI, cancer subgroup or CPAP treatment was predictive of ΔPSQITOTAL ≥ 3 auand p < 0.05 indicated statistical significance. The 60 patients recruited had breast cancer (n = 22), endometrial cancer (n = 15), and melanoma (n = 23).Cancer subgroups were similarly aged, and all had median follow-up PSQITOTAL scores ≥ 5au; breast cancer patients scoring the highest (p < 0.05). TheCPAPgroup had significantly reduced PSQITOTAL scores (p = 0.02)at follow-up, unlike thenon-CPAP group. Cancer subgroups had similar median ISITOTAL, ESSTOTAL and FOSQ-10TOTAL scoresat follow-up, regardless of CPAP treatment. There were no significant predictors of ΔPSQITOTAL ≥ 3 au at follow-up. Sleep-related symptoms persist in patients withcancer ≥ 3years aftertreatment, although these symptoms improve with CPAP. Future studies should evaluate how CPAP affects survival outcomes in cancer patients with comorbid OSA.

Long-term efficacy of mandibular advancement devices in the treatment of adult obstructive sleep apnea: A systematic review and meta-analysis.

This study aims to review the long-term subjective and objective efficacy of mandibular advancement devices (MAD) in the treatment of adult obstructive sleep apnea (OSA). Electronic databases such as PubMed, Embase, and Cochrane Library were searched. Randomized controlled trials (RCTs) and non-randomized self-controlled trials with a treatment duration of at least 1 year with MAD were included. The quality assessment and data extraction of the included studies were conducted in the meta-analysis. A total of 22 studies were included in this study, of which 20 (546 patients) were included in the meta-analysis. All the studies had some shortcomings, such as small sample sizes, unbalanced sex, and high dropout rates. The results suggested that long-term treatment of MAD can significantly reduce the Epworth sleepiness scale (ESS) by -3.99 (95%CI -5.93 to -2.04, p<0.0001, I2 = 84%), and the apnea-hypopnea index (AHI) -16.77 (95%CI -20.80 to -12.74) events/h (p<0.00001, I2 = 97%). The efficacy remained statistically different in the severity (AHI<30 or >30 events/h) and treatment duration (duration <5y or >5y) subgroups. Long-term use of MAD could also significantly decrease blood pressure and improve the score of functional outcomes of sleep questionnaire (FOSQ). Moderate evidence suggested that the subjective and objective effect of MAD on adult OSA has long-term stability. Limited evidence suggests long-term use of MAD might improve comorbidities and healthcare. In clinical practice, regular follow-up is recommended.

Abstract 13984: Obstructive Sleep Apnea and Quality of Life in Patients With Heart Failure or Coronary Heart Disease

Background: Obstructive sleep apnea (OSA), prevalent in patients with heart failure (HF) and those with coronary heart disease (CHD), is associated with poor quality of life (QoL) but underlying mechanisms are not well understood. Depressive symptoms and low perceived control, also common in these patients, may explain associations between OSA and QoL. Objective: To determine whether depressive symptoms and perceived control mediate the association of OSA with QoL among patients with HF or CHD. Method: We performed a serial mediation analysis using baseline data from an ongoing randomized comparative effectiveness trial from 222 adults with HF or CHD (male: 55%, age: 59±13 years, married: 65%). Obstructive sleep apnea was measured using the STOP-BANG that included information on s noring, t iredness, o bserved apnea, high blood p ressure, b ody mass index, a ge, n eck circumference, and g ender. Depressive symptoms were measured using the Patient Health Questionnaire-9. Perceived control was measured using the Control Attitude Scale-Revised (CASR). Quality of life was measured using the Functional Outcomes of Sleep Questionnaire. The analysis was conducted using PROCESS (Model 6) for SPSS. Results: Ninety-nine (45%) of participants had OSA. Obstructive sleep apnea was indirectly associated with QoL through the following paths: 1) depressive symptoms; 2) perceived control; 3) serially through both depressive symptoms and perceived control (Figure), indicating a mediating role for depressive symptoms and perceived control in the association of OSA with QoL. Conclusion: Because the relationship between OSA and poor QoL is mediated by depressive symptoms and perceived control, it is critical to screen patients for these conditions. As important, interventions need to be developed to reduce depressive symptoms and improve perceived control in order to improve patients’ QoL.

Impairment in Functioning and Quality of Life in Patients with Idiopathic Hypersomnia: The Real World Idiopathic Hypersomnia Outcomes Study (ARISE).

Idiopathic hypersomnia is a debilitating neurologic sleep disorder characterized by excessive daytime sleepiness, sleep inertia, and prolonged sleep. Its impact on patients' quality of life and daily functioning has not been fully elucidated. The Real World Idiopathic Hypersomnia Outcomes Study (ARISE) evaluated the daily functioning, relationships, cognition, emotional well-being, and productivity/employment of participants with idiopathic hypersomnia. ARISE was a US-based virtual cross-sectional survey comprising multiple patient-reported outcome measures (Functional Outcomes of Sleep Questionnaire, short version [FOSQ-10], Quality of Life in Neurological Disorders [Neuro-QoL] Social Roles and Stigma domains, British Columbia Cognitive Complaints Inventory [BC-CCI], Patient Health Questionnaire [PHQ-9], and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem [WPAI:SHP]). Participants were adults 21-65 years of age with idiopathic hypersomnia. Data were analyzed for all participants and for subgroups with/without long sleep time (LST; self-reported sleep ≥11 hours in 24 hours). Of 75 participants enrolled, most were female (81.3%) and the mean (SD) age was 34.1 (10.7) years. Participants' scores on the FOSQ-10 (mean [SD] score: 10.7 [2.8]) and the Neuro-QoL Social Roles (43.4 [4.2]) and Stigma (57.3 [5.9]) domains reflected impairments in daily functioning and quality of life. More than half of participants reported moderate to severe cognitive complaints (BC-CCI; 62.7%) and moderate to severe depressive symptoms (PHQ-9; 66.7%). Scores on the WPAI:SHP showed substantial impairments in absenteeism, presenteeism, overall work productivity, and overall regular daily activity (mean percent [SD]: 12.3 [23.6], 47.6 [22.7], 51.4 [24.7], and 64.0 [21.9], respectively). These considerable impairments were found in participants with and without LST. ARISE participants with idiopathic hypersomnia demonstrated poor quality of life and impaired functioning across multiple symptom domains.

Effectiveness and tolerability in people with narcolepsy transitioning from sodium oxybate to low-sodium oxybate: Data from the real-world TENOR study

ObjectivesThe Transition Experience of persons with Narcolepsy taking Oxybate in the Real-world (TENOR) study was conducted to provide real-world insight into the experience of people with narcolepsy switching from sodium oxybate (SXB) to low-sodium oxybate (LXB; 92% less sodium than SXB). MethodsTENOR is a patient-centric, prospective, observational, virtual-format study. Participants were adults with narcolepsy (type 1 or 2) who were transitioning from SXB to LXB treatment (±7 days from LXB initiation). Effectiveness and tolerability data were collected online from baseline (taking SXB) through 21 weeks (taking LXB) via daily and weekly diaries and questionnaires, including the Epworth Sleepiness Scale (ESS), the Functional Outcomes of Sleep Questionnaire, short version (FOSQ-10), and the British Columbia Cognitive Complaints Inventory (BC-CCI). ResultsTENOR participants (N = 85) were 73% female with a mean (SD) age of 40.3 (13.0) years. Mean (SD) ESS scores decreased numerically throughout the transition from SXB to LXB (baseline: 9.9 [5.2]; week 21: 7.5 [4.7]), with 59.5% and 75.0% of participants having scores in the normal range (≤10) at baseline and week 21, respectively. Mean (SD) FOSQ-10 scores (baseline: 14.4 [3.4]; week 21: 15.2 [3.2]) and BC-CCI scores (baseline: 6.1 [4.4]; week 21: 5.0 [4.3]) also remained stable. The most common symptoms related to tolerability reported by participants at baseline were sleep inertia, hyperhidrosis, and dizziness (45.2%, 40.5%, and 27.4%, respectively), which decreased in prevalence by week 21 (33.8%, 13.2%, and 8.8%, respectively). ConclusionsFindings from TENOR confirm maintenance of effectiveness and tolerability when transitioning from SXB to LXB treatment.

Subjective Efficiency Evaluation after Maxillomandibular Advancement Surgery in Obstructive Sleep Apnea Patients.

To investigate subjective efficiency outcomes after maxillomandibular advancement (MMA) surgery in obstructive sleep apnea (OSA) patients. A prospective cohort study was carried out between December 2016 and May 2021, including 30 severe or treatment-refractory OSA patients treated by MMA surgery. All patients answered four validated questionnaires: the Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Mandibular Function Impairment Questionnaire (MFIQ), and EQ-5D-3L (i.e., EQ-5D and EQ-VAS). They also answered one custom-made questionnaire (AMCSQ). Questionnaires were requested to be filled out 1 week before surgery and at least 6 months after surgery. The total preoperative and postoperative scores on the questionnaires were compared. The mean total ESS (p < 0.01), FOSQ (p < 0.01), EQ-5D (p < 0.05), and EQ-VAS (p < 0.01) scores showed significant improvement, which was in accordance with an improvement in the mean postoperative apnea/hypopnea index score (p < 0.01). In contrast, the mean total MFIQ score (p < 0.01) indicated a decline in mandibular function. This study confirms the hypothesis that MMA surgery in OSA patients improves outcomes, both objectively and subjectively, with the exception of postoperative mandibular function.

0453 3-Year Outcomes of Proximal Hypoglossal Nerve Stimulation in the THN3 Controlled Trial

Abstract Introduction The THN3 randomized, controlled trial of moderate to severe obstructive sleep apnea (OSA) showed that proximal (“targeted”) hypoglossal nerve stimulation (HGNS) safely improved sleep-disordered breathing (SDB) and quality of life (QOL) through 11 months of treatment. Outcomes of subjects receiving active proximal HGNS also surpassed those with inactive therapy 4 months post-implant. Herein 3-year outcomes of THN3 are reported and compared to distal HGNS (STAR trial). Methods THN3 OSA subjects (Apnea-Hypopnea Index, AHI, 20-65/hr; BMI ≤ 35 kg/m2, no drug-induced sleep endoscopy screening) were followed long-term. Complete data through 3-year follow-up were analyzed. Efficacy measures comprised AHI, Oxygen Desaturation Index (ODI), %sleep time O2 saturation &amp;lt; 90% (T90), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ) EQ-5D Visual Analog Scale (VAS) and Snore Outcomes Survey (SOS). 36-Month medians were compared against those after 11 months of therapy (Month 12/15) and with STAR. Adverse events (AEs) during Months 12-36 for THN3 and STAR were also compared. Results 75% of THN3 participants (104/138) attended 3-year follow-up, with complete efficacy records in N≥93 except for SOS (N=67, not administered at all sites). Proximal HGNS produced clinically and statistically significant improvements in SDB and QOL at Month 12/15 that were closely maintained at 36 Months (median paired changes at Month 36 from Baseline/Month 12/15: □AHI:-18.2/-0.1, □ODI:-16.2/0.8, □T90:-1.8/0.2, □FOSQ:3.0/0.0, □ESS:-5.0/0.0, □VAS:5.0/0.0, □SOS:37.5/3.1) and were comparable to STAR at 36 Months (□AHI:-19.4, □ODI:-17.2, □T90:-1.5, □FOSQ: 2.6, □ESS:-4.0). Procedure- and device-related AEs respectively totaled (3 and 27)/(4 and 122) in THN3/STAR over Months 12-36. During this time, 3 severe related-AEs occurred in THN3; the most frequent related AEs involved tongue discomfort (N=8, device-related). Conclusion Improvements in sleep apnea and QOL on proximal HGNS at Month 12/15 persisted through at least Month 36. Proximal HGNS long-term efficacy was comparable to distal HGNS. AEs occurred uncommonly during long-term follow-up and were typically mild. Proximal HGNS is a safe, effective, stable, long-term therapy, yielding comparable improvements to distal HGNS in treating moderate to severe OSA. Results of the ongoing, confirmatory OSPREY randomized controlled trial will provide additional insights into therapeutic benefits of proximal HGNS. Support (if any) LivaNova

0593 Functional Outcomes of Sleep Questionnaire in a phase 2 study of mazindol ER in narcolepsy

Abstract Introduction Efficacy secondary outcome measure Functional Outcomes of Sleep Questionnaire, Short Version (FOSQ-10] was collected in the Phase 2 (POLARIS, NLS-1021), multicenter (n=21) study of mazindol ER in adult participants with narcolepsy type 1 (NT1) or type 2 (NT2) (ClinicalTrials.gov Identifier: NCT04923594). Methods Adults diagnosed with NT1 or NT2 who were washed out of narcolepsy medications at baseline were included into the study. Patients were treated with mazindol ER (NLS-2) at once-daily 2 mg for one week and once-daily 3 mg thereafter or matching placebo (PBO) on a 1:1 ratio. Throughout the study, FOSQ-10 was assessed and compared vs. PBO scores at baseline. Treatment emergent adverse events (TEAEs) were assessed. Results Sixty-seven participants were randomized (NT1 33.3% in NLS-2 group versus 35.3% in PBO). At baseline, the mean [SD] FOSQ-10 score was 23.1 (5.5) for the NLS-2 arm and 23.7 (7.1) for the PBO arm. After four weeks of treatment, there was an increase of 4.1 (9.0) on NLS-2 vs an increase of 0.4 (6.9) on PBO (p = 0.04). Similar magnitude of effect was seen in NT1 patients (D = +4.7, p = 0.08, n = 20) as well as NT2 patients (D = +3.0, p = 0.20, n = 44) No serious adverse events were reported. The most frequently reported TEAEs (&amp;gt;5%) were dry mouth, nausea, decreased appetite and tachycardia. Conclusion Mazindol ER resulted in significant improvements of functional outcome measure FOSQ-10 These secondary outcome results support the efficacy of mazindol ER on cataplexy attacks, in NT1 patients, and on sleepiness, in NT1 as well as in NT2 patients. Support (if any) NLS Pharmaceutics

0448 Telemedicine Management of Obstructive Sleep Apnea Disorder: A Randomized Controlled Trial

Abstract Introduction Previous studies assessed different components of telemedicine instead of the whole telemedicine management pathway for OSA. The current study aimed to demonstrate that telemedicine management was not clinically inferior to in-person care in China based on the change in Functional Outcomes of Sleep Questionnaire (FOSQ) score following three months of an auto-adjusted positive airway pressure (APAP) treatment. Methods Adults suspected of OSA were randomized to telemedicine (n=178) or in-person (n=178) management. Participants with AHI ≥ 15 events/hour diagnosed by a home sleep apnea test (HSAT) were treated with an APAP with a wireless modem. The participants were followed up by call at week 1 and visit at month 1 and month 3. Results We measured the change in FOSQ score as the primary outcome, with an a priori noninferiority delta of -1, and the mean daily hours of objectively measured APAP adherence, with an a priori noninferiority delta of -45min/day. Of the 356 subjects enrolled, 313 (87.9%) were diagnosed with OSA, and 261 (73.3%) underwent PAP setup. The mean functional outcome score following 3 months improved 1.73 points (95%CI: 1.31, 2.14) in the telemedicine group and 2.05 points (95% CI: 1.64, 2.46) in the in-person group. The lower bound of the one-sided 95% noninferiority confidence interval was -0.812. Mean daily APAP adherence at 3 months was 243.3 minutes/night (95% CI: 223.1, 263.5) in the telemedicine arm and 241.6 minutes/night (95% CI: 221.3, 261.8) in the in-person arm. The lower bound of the one-sided 95% noninferiority confidence interval was -22.2 minutes/night. Compared to in-person management, the telemedicine pathway had lower patients cost and similar health care cost. Conclusion Functional outcome and treatment adherence in patients managed by a comprehensive telemedicine approach is not clinically inferior to that in patients receiving in-person care. Support (if any) ResMed Australia funded the APAP machines. The study was supported by the National Key R&amp;D Program of China (Z161100002616012). Liyue Xu is supported by a grant from the National Natural Science Foundation of China (NSFC 82100104).

0459 Cardiovascular Endpoints for Obstructive Sleep Apnea with Twelfth Nerve Stimulation: Measures of Sleep-Related Function

Abstract Introduction Obstructive sleep apnea (OSA) is an increasingly prevalent sleep-related breathing disorder linked to cognitive dysfunction and daytime sleepiness. Positive airway pressure (PAP) therapy, the first-line treatment for OSA, may improve cognitive function and sleepiness, but responses vary. Hypoglossal nerve stimulation (HGNS) is a novel and effective PAP alternative, but its effect on mitigating cognitive decline secondary to OSA is unknown. In the first sham-controlled HGNS trial, we evaluated the effect of HGNS therapy on cognitive measures and patient-reported outcomes (PROs) in patients with moderate-severe OSA. Methods In a double-blind, sham-controlled, randomized crossover therapy trial, patients already stabilized on HGNS therapy underwent four weeks of active and four weeks of sham HGNS, each with a 1-week washout period. Sham therapy was defined as the lowest voltage at which HGNS was sensed by the patient or visualized by the clinician. Cognitive measures (Psychomotor Vigilance Test [PVT], Digit Symbol Substitution Task [DSST]) and sleep-related PROs (Epworth Sleepiness Scale [ESS], Snoring Visual Analog Scale [VAS], Insomnia Severity Index [ISI], Functional Outcomes of Sleep Questionnaire [FOSQ]) were assessed after each 4-week period and compared between active and sham therapy. Results Sixty randomized patients were included. On average, participants were elderly (67.3±9.9 years), overweight (BMI 28.7±4.6 kg/m2) and had severe OSA prior to HGNS therapy (AHI 33.1±14.9 events/hour). Patients’ AHI decreased to 23.0±15.6 events/hour with sham therapy (p=0.0001) and 18.1±14.8 events/hour with active therapy (p&amp;lt; 0.0001), with a 4.9 event/hour decrease between active and sham therapy (p=0.014). There were no significant differences in performance measures on PVT or DSST between active and sham HGNS. All sleep-related PROs were statistically significant with moderately large (effect sizes ~0.41-0.56) improvements following active HGNS. Conclusion The HGNS system permits a unique investigation of the therapy “on/off” effect on measures of cognitive function. In the first sham-controlled, randomized crossover trial of patients using HGNS, all sleep-related PROs, but not objective measures of cognition, were significantly different between sham and active (therapeutic) levels. These findings warrant additional investigation examining the relationship between subjective and objective measures of function in OSA. Support (if any) American Heart Association (17SDG33670349) American Sleep Medicine Foundation (176-JF-17) National Institutes of Health (P01-HL094307)

0871 Outcomes in Overlap Syndrome of COPD and OSA: A Secondary Data Analysis of STAGES

Abstract Introduction Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) are highly prevalent, and termed Overlap Syndrome (OVS) when coexistent. Patient-reported outcomes (PROs) are impaired in both COPD and OSA alone, but their combined impact is unclear. We examined differences in the impact of COPD on PROs in adults with and without OSA. Methods Analyses included adults aged≥8 years with polysomnographic (PSG) data from the Stanford Technology Analytics and Genomics in Sleep (STAGES) study. We created sets of individuals with and without COPD, matched up to 1:5 on age±5 years, BMI±2.5 kg/m2, AHI±5 events/hour, and sex. Among all matched sets, we estimated the impact of COPD on fatigue (Fatigue Severity Scale), sleepiness (Epworth Sleepiness Scale), anxiety (Generalized Anxiety Disorder Questionnaire), depression (Personal Health Questionnaire-9), insomnia (Insomnia Severity Index), and function (Functional Outcomes of Sleep Questionnaire) using linear mixed effects models. We also examined whether the effect of COPD differed between those with (AHI≥10 events/hour) and without (AHI&amp;lt; 10 events/hour) OSA. Results Overall, 56 patients with COPD were matched to a total of 199 non-COPD controls (51.0% males). The sample was middle aged (55.8±11.8 years), overweight/obese (BMI 29.8±6.9 kg/m2), and had mild/moderate OSA (AHI 11.0±11.5 events/hour) on average; 26 (46.4%) of COPD cases had an AHI≥10. Among all patients, COPD was associated with worse PROs on average (p&amp;lt; 0.05 for all but ESS [p=0.070]). Among those with AHI&amp;lt; 10, there were no differences for any PRO between groups with and without COPD. However, COPD was associated with worse values of all PROs among those with OSA, including fatigue (mean [95% CI] difference = 9.8 [2.9, 16.7], p=0.006), sleepiness (2.8 [0.01, 5.7], p=0.050), anxiety (3.6 [1.1, 6.0], p=0.005), depression (4.4 [1.8, 7.0], p=0.001), insomnia (4.8 [2.0, 7.6], p=0.001) and function (-3.3 [-5.2, -1.5], p=0.001). Conclusion The effect of COPD on PROs is modified by OSA, with worse outcomes among those with OVS compared to OSA alone, but no impact of COPD among those without OSA. Identification of adults with OVS through early screening is crucial to prompt treatment of disease and reduce symptom burden. Support (if any) T32HL07713 P01 HL094307

Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea

Evidence is lacking from randomized clinical trials of hypoglossal nerve stimulation in obstructive sleep apnea (OSA). To evaluate the safety and effectiveness of targeted hypoglossal nerve stimulation (THN) of the proximal hypoglossal nerve in patients with OSA. This randomized clinical trial (THN3) was conducted at 20 centers and included 138 patients with moderate to severe OSA with an apnea-hypopnea index (AHI) of 20 to 65 events per hour and body mass index (calculated as weight in kilograms divided by height in meters squared) of 35 or less. The trial was conducted from May 2015 through June 2018. Data were analyzed from January 2022 through January 2023. Implant with THN system; randomized 2:1 to activation at month 1 (treatment) or month 4 (control). All received 11 months of THN with follow-up at months 12 and 15, respectively. Primary effectiveness end points comprised AHI and oxygen desaturation index (ODI) responder rates (RRs). Treatment responses at months 4 and 12/15 were defined as a 50% or greater reduction in AHI to 20 or less per hour and an ODI decrease of 25% or greater. Coprimary end points comprised (1) month 4 AHI and ODI RR in the treatment greater than the control group and (2) month 12/15 AHI and ODI RR in the entire cohort exceeding 50%. Secondary end points included sleep apnea severity (AHI and ODI) and patient-reported outcomes (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale). Among 138 participants, the mean (SD) age was 56 (9) years, and 19 (13.8%) were women. Month 4 THN RRs were substantially greater in those in the treatment vs control group (AHI, 52.3% vs 19.6%; ODI, 62.5% vs 41.3%, respectively) with treatment-control standardized mean differences of 0.725 (95% CI, 0.360-1.163) and 0.434 (95% CI, 0.070-0.843) for AHI and ODI RRs, respectively. Months 12/15 RRs were 42.5% and 60.4% for AHI and ODI, respectively. Improvements in AHI, ODI, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale scores were all clinically meaningful (medium to large effect size). Two serious adverse events and 100 nonserious related adverse events were observed from the implant procedure or study protocol. This randomized clinical trial found that THN demonstrated improvements in sleep apnea, sleepiness, and quality of life in patients with OSAs over an extended AHI and body mass index range without prior knowledge of pharyngeal collapse pattern. Clinically meaningful improvements in AHI and patient-reported responses compared favorably with those of distal hypoglossal nerve stimulation trials, although clinically meaningful differences were not definitive for ODI. ClinicalTrials.gov Identifier: NCT02263859.

Sleep and Military Leaders: Examining the Values, Beliefs, and Quality of Sleep and the Impact on Occupational Performance.

Sleep deprivation is rampant within the military population, and insufficient sleep can lead to physical and mental health problems impacting soldier's readiness and deployability. Past research has shown the importance of leadership's role in subordinates' sleep health. Understanding the values, beliefs, and quality of military leader sleep is essential to the development of effective interventions to optimize occupational performance and overall sleep health. Therefore, the purpose of this study was to examine the military leaders' values, beliefs, and sleep quality and the impact on occupational performance. The authors aimed to (1) identify military leaders' sleep quality and beliefs; (2) explore the relationship between military leaders' sleep quality, beliefs and attitudes about sleep, and impact on occupational performance; and (3) examine the value leaders place on sleep for themselves and subordinates in relation to occupational performance. This observational, mixed-methods study design recruited a convenience sample of 109 Army active duty medical service members currently serving in a leadership role. Participants completed an electronic survey to include general demographic information and three self-report measures: the Pittsburgh Quality of Sleep Index, the Dysfunctional Beliefs about Sleep, and the Functional Outcomes of Sleep Questionnaire. Eleven participants completed the semi-structured qualitative interview focusing on sleep values and the impacts on performance. Univariate and multivariate regressions were performed for statistical analysis of the quantitative survey data, whereas thematic analysis was used to analyze the qualitative interview data. This study was approved by the U.S. Army Medical Center of Excellence Institutional Review Board. Multivariate regression analysis demonstrated small-to-medium effect sizes (R2 = 0.355-0.559) for relationships between sleep quality, sleep beliefs, functional performance, and demographic variables. More specifically, military grade, position, use of alcohol, time in service, and gender were all found to contribute significantly to scores on the Pittsburgh Sleep Quality Index, the Dysfunctional Beliefs About Sleep Scale-16, and the Functional Outcomes of Sleep Questionnaire-10 (P < .05). Qualitative data resulted in three primary themes: (1) Poor sleep degrades performance, (2) sleep is a top priority, and (3) leaders have a responsibility for subordinates' sleep health. This sample of military leaders was found to perceive themselves as poor-quality sleepers despite demonstrating more functional attitudes and beliefs about sleep and reporting normal-to-mild impairments in daily functioning as a result of daytime sleepiness. Furthermore, findings suggest that leaders' sleep quality and beliefs stand to be further improved, whereas their sleep values need to be consistently demonstrated to subordinates. With a clearer understanding of military leaders' values, beliefs, and sleep quality, future research could focus on implementing and developing holistically based and individualized sleep interventions intended to optimize performance and sleep health.

Power spectral analysis of the sleep electroencephalogram in positional obstructive sleep apnea

Objective/BackgroundPrevious studies have shown that obstructive sleep apnoea (OSA) is associated with reduced delta EEG and increased beta EEG power and increased EEG slowing ratio. There are however no studies that explore differences in sleep EEG between positional obstructive sleep apnoea (pOSA) and non-positional obstructive sleep apnoea (non-pOSA) patients. Patients/methods556 of 1036 consecutive patients (246 of 556 were female) undertaking polysomnography (PSG) for the suspicion of OSA met the inclusion criteria for this study. We calculated power spectra of each sleep epoch using Welch's method with ten, 4-s overlapping windows. Outcome measures such as Epworth Sleepiness Scale, SF-36 Quality of Life, Functional Outcomes of Sleep Questionnaire and Pyschomotor Vigilance Task were compared between the groups. ResultsPatients with pOSA had greater delta EEG power in NREM and greater N3 proportions compared to their non-pOSA counterparts. There were no differences in theta (4–8Hz), alpha (8–12Hz), sigma (12–15Hz) or beta (15–25Hz) EEG power or EEG slowing ratio between the two groups. There were also no differences in the outcome measures between these two groups. The division of pOSA into spOSA and siOSA groups showed better sleep parameters in siOSA but with no difference in sleep power spectra. ConclusionsThis study partially supports our hypothesis in showing that pOSA, compared to non-pOSA, is associated with increased delta EEG power but did not show any variation to beta EEG power or EEG slowing ratio. This limited improvement in sleep quality did not translate to measurable changes to outcomes, suggesting beta EEG power or EEG slowing ratio may be key factors.

Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation (READ-ASV): protocol and cohort profile.

Although adaptive servo-ventilation (ASV) effectively supresses central sleep apnoea (CSA), little is known about real-world indications of ASV therapy and its effects on quality of life (QoL). This report details the design, baseline characteristics, indications for ASV and symptom burden in patients enrolled in the Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation (READ-ASV). This multicentre, European, non-interventional trial enrolled participants prescribed ASV in clinical practice between September 2017 and March 2021. An expert review board assigned participants to ASV indications using a guideline-based semi-automated algorithm. The primary end-point was change in disease-specific QoL based on the Functional Outcomes of Sleep Questionnaire (FOSQ) from baseline to 12-month follow-up. The registry population includes 801 participants (age 67±12 years, 14% female). Indications for ASV were treatment-emergent or persistent CSA (56%), CSA in cardiovascular disease (31%), unclassified CSA (2%), coexisting obstructive sleep apnoea and CSA (4%), obstructive sleep apnoea (3%), CSA in stroke (2%) and opioid-induced CSA (1%). Baseline mean apnoea--hypopnoea index was 48±23 events·h-1 (≥30 events·h-1 in 78%), FOSQ score was 16.7±3.0 (<17.9 in 54%) and Epworth Sleepiness Scale (ESS) score was 8.8±4.9 (>10 in 34%); 62% of patients were symptomatic (FOSQ score <17.9 or ESS score >10). The most common indications for ASV were treatment-emergent or persistent CSA or CSA in cardiovascular disease (excluding systolic heart failure). Patients using ASV in clinical practice had severe sleep-disordered breathing and were often symptomatic. One-year follow-up will provide data on the effects of ASV on QoL, respiratory parameters and clinical outcomes in these patients.