Functional Outcomes Of Sleep Questionnaire Research Articles

Association of Insomnia with Functional Outcomes Relevant to Daily Behaviors and Sleep-Related Quality of Life among First Nations People in Two Communities in Saskatchewan, Canada.

Insomnia is a common sleep complaint in Canada and is associated with increased use of health care services and economic burden. This paper examines the association of insomnia with functional outcomes relevant to daily behaviors and sleep-related quality of life among First Nations participants using the Functional Outcomes of Sleep Questionnaire (FOSQ-10). The First Nations Sleep Health Project follow-up survey was conducted in partnership with two Cree First Nations in the summer of 2022, where 355 individuals participated. Statistical analysis was conducted using logistic regression models. The mean age of the participants was 40.76 ± 14.60 (SD) years, and 59.4% were females. The prevalence of chronic insomnia (Insomnia Severity Index score of ≥15) was 21.0%, with more females (26.1%) than males (13.8%) experiencing it among the 348 participants. Overall, the mean FOSQ-10 score was 17.27 ± 2.98 among the 350 participants, with those who had clinical insomnia reporting significantly lower scores than those without clinical insomnia (mean ± SD: 14.6 ± 3.9 vs. 18.0 ± 2.1; p < 0.001). The FOSQ-10 scores indicated sleep-related functional impairment (FOSQ-10 total score < 17.90) in 46.6% of participants. After adjusting for age, excessive daytime sleepiness, sex, and regular use of prescription medication, we found that clinical insomnia was significantly associated with functional impairments. In fact, a person with clinical insomnia was 3.5 times more likely to have functional impairments than those without clinical insomnia. This study highlights the significant association between insomnia and functional impairments related to daily behaviors and quality of life in two First Nation communities. Identifying this association can help healthcare providers to diagnose and treat patients with insomnia in these communities.

The effects of Aerobic and oropharyngeal exercises on sleep quality of patients with obstructive sleep Apnoea syndrome: a randomized controlled study.

Our objective was to examine the effect of co-treatment of aerobic and oropharyngeal exercises on daytime sleepiness, sleep quality, fatigue severity, and life quality in patients with obstructive sleep apnea (OSA) syndrome. This study was conducted as a randomized controlled trial with individuals aged 18 to 65 diagnosed with OSA at the Sleep Polyclinic and Research Hospital in Turkey between September 2023 and December 2023. The exercise group (n = 12) followed an eight-week oropharyngeal exercise program and the combined exercise group (n = 13) followed an aerobic exercise in addition to oropharyngeal exercises. The control group (n = 15) did not receive any exercise. Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), Modified Medical Research Council (mMRC) Dyspnoea Scale, Functional Outcomes of Sleep Questionnaire (FOSQ) were used as outcome measures. The protocol is registered with http://clinicaltrials.gov/ (01/September /2023, Clinical Trial, NCT06006520). Both exercise programs were effective in improving daytime sleepiness, sleep quality, fatigue severity, and life quality. The mMRC dyspnoea scale, FOSQ, and PSQI scores did not differ between groups pre-and post-intervention. Participants receiving oropharyngeal exercise therapy showed a significant reduction in ESS and FSS scores compared to the combination treatment group. A comprehensive program of oropharyngeal exercises produced better changes in fatigue severity and daytime sleepiness in moderate to severe OSA patients compared to the combination of aerobic and oropharyngeal exercises.

Phrenic nerve stimulation for central sleep apnea: a single institution experience

PurposePhrenic nerve stimulation (PNS) was approved by the Food and Drug Administration (FDA) to treat moderate to severe central sleep apnea. We report here, results of a retrospective study regarding our institutional outcomes at one year. In this study we evaluated the change in the apnea hypopnea index, epworth sleepiness score, and functional outcomes of sleep score at one year post implant.MethodsThis is a retrospective analysis of patients ≥ 18 years of age who had PNS implanted for moderate to severe CSA at the Ohio State University Wexner Medical Center apnea between Feb 1, 2018 to July 1, 2021. Sleep disordered breathing parameters and objective sleepiness as measured by the Epworth Sleepiness Scale (ESS) scores, and Functional Outcomes of Sleep Questionnaire (FOSQ) scores were assessed at baseline and one-year post-implant.ResultsTwenty-two patients were implanted with PNS at OSU between February 1, 2018 and May, 31, 2022. The AHI showed a statistically significant decrease from a median of 40 events/hour at baseline to 18 at follow-up (p-value = 0.003). The CAI decreased from 16 events/hour to 2 events/hour (p-value of 0.001). The obstructive apnea index, mixed apnea index, and hypopnea index did not significantly change. The ESS scores had a statistically significant improvement from a median score of 12 to 9 (p-value = 0.028). While the FOSQ showed a trend to improvement from 15.0 to 17.8, it was not statistically significant (p-value of 0.086).ConclusionOur study found that PNS therapy for moderate to severe CSA improves overall AHI and CAI. Objective sleepiness as measured by the ESS also improved at one-year post implant.

Novel physiologic predictors of positive airway pressure effectiveness (NICEPAP) study: rationale, design and methods.

Continuous positive airway pressure (CPAP) is the primary therapy for obstructive sleep apnea (OSA); however the effectiveness of CPAP remains suboptimal. We describe the Novel PhysIologiC prEdictors of Positive Airway Pressure Effectiveness (NICEPAP) study. Its purpose is to determine whether physiological traits of OSA contribute to CPAP effectiveness. NICEPAP (NCT05067088) is a prospective, observational cohort study conducted at an academic sleep center. Adults newly diagnosed with OSA (n = 267) are assessed for OSA traits of loop gain, arousal threshold, pharyngeal collapsibility, and muscle compensation from baseline polysomnography. We perform a comprehensive assessment of covariates relevant to CPAP adherence, efficacy, and patient-centered outcomes. Participants are followed for 12 months. Primary outcomes include (1) CPAP adherence (hours/night), (2) CPAP efficacy (apneas-hypopneas/hour), and (3) quality of life at six months measured by objective CPAP data and Functional Outcomes of Sleep Questionnaire. Secondary outcomes include sleep quality, sleepiness, insomnia, and neurocognitive function. Data on covariates, including demographics, sleep symptoms, medical history, medications, sleep quality, OSA and treatment self-efficacy, decisional balance, and socio-economic and social and partner support, are collected using validated instruments. The analysis for primary outcomes includes a generalized linear mixed model for an outcome (e.g., CPAP adherence) with OSA traits as exposures followed by the addition of relevant covariates. The findings of the NICEPAP study will inform research aimed to enhance CPAP effectiveness. Understanding the role of physiological OSA traits in CPAP effectiveness is a crucial step toward a precision medicine approach to OSA.

Prevalence of Somatic Symptom Disorder in Students of Tertiary Educational Institutes in Pakistan and Its Correlation With Academic Performance and Sleep Quality

Objective: Somatic symptom disorder (SSD) is a disorder characterized by several somatic symptoms without medical explanation. SSD has been a burden on healthcare for ages and its awareness is not widespread among the healthcare professionals or population. This study aims to find out the prevalence of SSD among university students in Pakistan and whether it is affecting their academic performance or sleep quality. Methods: It is an observational study conducted in Pakistan in June 2023. A sample size of 381 participants was used. Patient Health Questionnaire-15 was used as SSD diagnosis, Academic Performance Scale for measuring academic performance, and Functional Outcome of Sleep Questionnaire for rating sleep quality. SPSS software 27.0 was used as a statistical tool for analysis using descriptive statistic and tests like frequency, chi-square, and crosstabs. Results: The study found a 48.8% prevalence of SSD among Pakistani students, with higher rates in females (65.6%), and no age-related correlation (p=0.341). Furthermore, the relation between academic performance of students with SSD was significant (p&lt;0.001), whereas sleep quality was unaffected by SSD (p=0.281). Conclusion: The frequency of SSD is approximately 48.8% among the students in Pakistan. This high prevalence has been recorded to negatively affect the academic performance of the students and is more prevalent in females than males. However, it is not related to age and it does not cause any sleep disturbance. Future studies should focus on the risk factors of SSD and better treatment plans for effective control and awareness of this disorder.

Silent struggles: Mapping the terrain of sleep, anxiety, and depression in the Era of pandemic for individuals with multiple sclerosis- a cross-sectional study

BackgroundThe pandemic's preventive measures adversely impacted physical and psychological well-being, leading to increased sleep issues and mental health problems. This study examines sleep health and mental well-being among individuals with multiple sclerosis (MS) during this period. It explores potential correlations between sleep problems and mental health in this population. MethodsA cross-sectional design utilized an anonymous SurveyMonkey survey distributed to three MS centers, collecting responses from 24 individuals with MS (21 females, 3 males). Sleep data were assessed using the Functional Outcome of Sleep Questionnaire (FSOQ)-10, and mental health status was assessed using the Depression Anxiety Stress Scale (DASS)-21. FOSQ scores ≥17.9 indicated normal sleep, while the DASS-21 comprised stress, anxiety, and depression subscales, each with 7 questions rated on a 0–3 scale, with higher scores indicating greater mental health issues. ResultsOf 24 participants, 18 MS individuals reported functional sleep issues during the pandemic. Analysis revealed significantly lower productivity, vigilance, and social outcomes in the sleep problems group (p < .01). Additionally, this group had elevated stress (p = .004) and depression scores (p = .002). Negative correlations were observed between sleep scores and both stress (ρ = -0.485, p = .016) and depression (ρ = -0.562, p = .004). Conclusions75 % of MS individuals experienced functional sleep disturbances during the pandemic, with 25 % affected by stress, 16.6 % by anxiety, and 37 % by depression. Sleep issues are correlated with increased stress and depression levels. Recognizing the impact on rehabilitative outcomes, specialists must consider sleep behavior and mental health when designing therapies for individuals with MS.

An empirical comparison of sleep-specific versus generic quality of life instruments among Australians with sleep disorders

PurposeIn Australian adults diagnosed with a sleep disorder(s), this cross-sectional study compares the empirical relationships between two generic QoL instruments, the EuroQoL 5-dimension 5-level (EQ-5D-5L) and ICEpop CAPability measure for Adults (ICECAP-A), and three sleep-specific metrics, the Epworth Sleepiness Scale (ESS), 10-item Functional Outcomes of Sleep Questionnaire (FOSQ-10), and Pittsburgh Sleep Quality Index (PSQI).MethodsConvergent and divergent validity between item/dimension scores was examined using Kendall’s Tau-B correlation, with correlations below 0.30 considered weak, between 0.30 and 0.50 moderate and those above 0.50 strong (indicating that instruments were measuring similar constructs). Exploratory factor analysis (EFA) was conducted to identify shared underlying constructs.ResultsA total of 1509 participants (aged 18–86 years) were included in the analysis. Convergent validity between dimensions/items of different instruments was weak to moderate. A 5-factor EFA solution, representing ‘daytime dysfunction’, ‘fatigue’, ‘wellbeing’, ‘physical health’, and ‘perceived sleep quality’, was simplest with close fit and fewest cross-loadings. Each instrument’s dimensions/items primarily loaded onto their own factor, except for the EQ-5D-5L and PSQI. Nearly two-thirds of salient loadings were of excellent magnitude (0.72 to 0.91).ConclusionModerate overlap between the constructs assessed by generic and sleep-specific instruments indicates that neither can fully capture the complexity of QoL alone in general disordered sleep populations. Therefore, both are required within economic evaluations. A combination of the EQ-5D-5L and, depending on context, ESS or PSQI offers the broadest measurement of QoL in evaluating sleep health interventions.

Effect of melatonin on insomnia and daytime sleepiness, in patients with obstructive sleep apnea and insomnia (COMISA): A randomized double-blinded placebo-controlled trial

BackgroundCOMISA is a common disorder that results in nighttime awakenings ,daytime sleepiness and PAP intolerance. Cognitive behavioral therapy for insomnia is used to improve PAP adherence and no medication has been evaluated in such population yet. Melatonin with its chronobiotic and antioxidant effects may have potential benefits on COMISA consequences at the appropriate dose and time. This study aimed to evaluate the effect of melatonin on sleep quality, daytime sleepiness and PAP Compliance in patients with COMISA.MethodsThis double-blind placebo trial randomly assigned eligible OSA patients who suffered from insomnia despite using PAP for over a month to receive either melatonin 10 mg or placebo. The primary outcomes were measured by changes in the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire (FOSQ-10) over one month. Adherence to PAP was measured by the results of the PAP device reports on the average length of time and number of nights that the device was used.ResultsThirty patients were enrolled in the study after randomization. The melatonin arm showed significant improvement in all four primary outcomes compared to the placebo arm. The PSQI score was 3.836±1.839 in the melatonin arm versus 10.522±3.626 in the placebo arm (Pvalue<0.001). The ISI score was 8.476±3.568 in the melatonin arm versus 14.47±4.50 in the placebo arm (Pvalue<0.001). The ESS score was 6.854±4.334 in the melatonin arm versus 13.298±5.119 in the placebo arm (Pvalue<0.001). The FOSQ-10 score was 24.93±5.02 in the melatonin arm versus 19.87±4.24 in the placebo arm (Pvalue= 0.006). Additionally, nighttime consequences such as sleep latency and awakenings showed significant improvement in the melatonin arm. PAP devices results revealed improvement in duration of PAP use overnight. ConclusionsAdministering melatonin has been shown to improve self-reported sleep quality and PAP adherence in patients with COMISA.Trial registrationRegistration number IRCT20220105053635N1 was issued by the Iranian Registry of Clinical Trials (IRCT).

Gender differences in oral appliance treatment of obstructive sleep apnea

PurposeAlthough 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.MethodsA 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.ResultsAmong 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.ConclusionBoth 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

PurposeThe 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).MethodsInclusion criteria were Thai patients with SDB age ≥ 18 years 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-10 T and Epworth sleepiness scales (ESS). Of these, 38 patients were required to retake FOSQ-10 T at 2–4 weeks later to assess test–retest reliability, and 19 OSA patients treated with CPAP were asked to do so at 4 weeks following therapy to assess questionnaire’s responsiveness to treatment.ResultsThere were 42 participants (24 men, 18 women), with a mean age of 48.3 years. 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.ConclusionsThe 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.

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