Daytime sleepiness, a common symptom of obstructive sleep apnea (OSA), can be measured via multiple patient-reported outcome questionnaires. It is hypothesized that tirzepatide may reduce daytime sleepiness, as it showed significant improvements in the apnea hypopnea index in the SURMOUNT-OSA trials. Two phase 3 studies evaluated the efficacy of the maximum tolerated dose of tirzepatide (TZP, 10 or 15 mg) versus placebo in participants with moderate-to-severe OSA and obesity. Study 1 participants were not on positive airway pressure (PAP) therapy at baseline while Study 2 participants were on PAP therapy. Post-hoc analyses grouped participants based on baseline PGIS Sleepiness responses: “not at all/slightly sleepy” (Non-sleepy) or “moderately/very sleepy” (Sleepy). Changes from baseline to Week 52 of sleep-related measures (Epworth Sleepiness Scale [ESS], PROMIS Short Form Sleep-related Impairment [PROMIS-SRI], Functional Outcomes of Sleep Questionnaire [FOSQ]) were compared between TZP and placebo by subgroups, based on mixed model repeated measure methods using on-treatment data. Lower ESS and PROMIS-SRI scores and higher FOSQ scores indicate improvement. Patient Global Impression of Change [PGIC] Sleepiness responses were also calculated. Significant P-values are reported using “*” to denote values < 0.05. In Study 1 (N=194), there were placebo-adjusted changes from baseline to Week 52 with TZP treatment on the ESS (Non-sleepy: -1.33, Sleepy: -2.18), PROMIS-SRI (Non-sleepy: -1.6, Sleepy: -7.1*), and FOSQ Vigilance domain (Non-sleepy: 0.09, Sleepy: 0.28). Over half of participants treated with TZP reported that they were less sleepy (Non-sleepy: 55.0%; Sleepy: 60.9%). Study 2 participants (N=193) experienced placebo-adjusted improvements from baseline to Week 52 on the ESS (Non-sleepy: -1.02, Sleepy: -0.57), PROMIS-SRI (Non-sleepy: -4.3*, Sleepy: -5.6*), and FOSQ Vigilance domain (Non-sleepy: 0.15, Sleepy: 0.03). On the PGIC Sleepiness item, 46.6% of Non-Sleepy participants and 62.5% of Sleepy participants reported that they were less sleepy at Week 52, in participants treated with TZP. This post-hoc analysis found that TZP-treated participants who were “moderately/very sleepy” at baseline generally showed greater improvement on ESS, PROMIS-SRI, and FOSQ Vigilance domain than those “not at all/slightly sleepy”, especially participants not on PAP therapy. Over half of all TZP-treated participants reported improvements in overall sleepiness, despite sleepiness at baseline.
Fatigue, a symptom of obstructive sleep apnea (OSA), is measurable through patient-reported outcome questionnaires. Tirzepatide improved the apnea hypopnea index in SURMOUNT-OSA trials and is hypothesized to improve fatigue and functioning in individuals with moderate-to-severe OSA and obesity. Two Phase 3 studies evaluated the maximum tolerated dose of tirzepatide (TZP, 10 or 15 mg) vs placebo in participants with obesity and moderate-to-severe OSA. Study 1 participants were not on PAP therapy, while Study 2 participants were on PAP therapy. Post-hoc analyses categorized participants based on baseline PGIS responses: “no/mild fatigue” (Non-Fatigued) or “moderate/severe fatigue” (Fatigued). Improvements in fatigue and/or functioning were assessed by PGIC Fatigue, FOSQ-10, FOSQ (Activity domain) and SF-36v2 (General Health and Vitality domains). Higher scores indicate improvement. Treatment associations were measured as the differences in change from baseline between TZP and placebo at Week 52, computed with mixed model repeated measure methods using on-treatment data. Significant P-values are reported using “*” to denote values < 0.05. In Study 1 (N=194), treatment associations at Week 52 were observed in FOSQ-10 (Non-Fatigued: 0.3, Fatigued: 0.9), FOSQ Activity (Non-Fatigued: 0.05, Fatigued: 0.33*), SF-36v2 General Health (Non-Fatigued: 1.4, Fatigued: 6.2*) and SF-36v2 Vitality (Non-Fatigued: 1.0, Fatigued: 8.5*). Of participants treated with TZP, 71.7% (N=43) Non-Fatigued and 69.7% (N=23) Fatigued participants rated their fatigue as “A little better” or “much better.” Participants treated with placebo were less likely to report the same improvements (Non-Fatigued: 22.6%, N=12; Fatigued: 20.9%, N=10). In Study 2 (N=193), treatment associations were experienced on the FOSQ-10 (Non-Fatigued: 0.7, Fatigued: 0.3), FOSQ Activity (Non-Fatigued: 0.13, Fatigued: 0.15), SF-36v2 General Health (Non-Fatigued: 6.5*, Fatigued: 9.7*) and SF-36v2 Vitality (Non-Fatigued 5.7*, Fatigued: 6.0*). More participants treated with TZP reported improvements in fatigue (Non-Fatigued: 51.0%, N=26, Fatigued: 59.6%, N=28) compared to those receiving placebo (Non-Fatigued: 25.9%, N=14; Fatigued: 21.9%, N=9). In this post hoc analysis, TZP-treated participants, not on PAP therapy, and with “moderate/severe” fatigue at baseline generally showed greater improvements in fatigue/functioning. Those on PAP therapy with “moderate/severe” fatigue at baseline improved only on the SF-36v2 General Health and FOSQ Activity domains. All participants treated with TZP improved compared to placebo.
Aim In the phase 3 SURMOUNT-OSA trials, tirzepatide treatment significantly reduced the apnea-hypopnea index (AHI) among people with moderate-to-severe obstructive sleep apnea (OSA) and obesity. We evaluated effects of tirzepatide treatment on sleep disturbance, sleep-related impairment, functioning, health-related quality of life (HRQoL), and OSA symptoms in SURMOUNT-OSA participants. Methods SURMOUNT-OSA consisted of two randomized, placebo-controlled trials of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks in participants with moderate-to-severe OSA and obesity. For participants using PAP (Study 2), PAP was withdrawn prior to assessments of polysomnography and patient-reported outcome measures (PROMs). Prespecified PROM endpoints were from baseline to Week 52. Changes in sleep-related impairment, sleep disturbance, excessive daytime sleepiness, functioning, and HRQoL were assessed using analysis of covariance. Categorical shifts in OSA symptom severity were described. Results At Week 52, compared with placebo, tirzepatide-treated participants reported significantly improved Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form Sleep-related Impairment 8a scores, PROMIS Short-Form v1.0 Sleep Disturbance 8b scores, Functional Outcomes of Sleep Questionnaire Activity-Level scores, EQ-5D-5L scores, and most domains of the Short-Form 36 Health Survey, Version 2. Tirzepatide treatment was also associated with greater improvements in Patient Global Impression of Status and Patient Global Impression of Change symptom scales compared with placebo. Additionally, Study 1 participants reported significant changes in Epworth Sleepiness Scale scores. Conclusion Results indicate that in addition to objective outcomes of improved AHI, hypoxic burden associated with OSA, and cardiovascular risk factors, people with OSA reported benefits in symptoms, functioning, and HRQoL following tirzepatide treatment. Clinicaltrials.gov number NCT05412004.
Obstructive sleep apnea (OSA) can impair sleep quality. Tirzepatide has shown improvements in the apnea hypoxia index and is hypothesized to improve sleep quality in participants with moderate-to-severe OSA and obesity. Two phase 3 studies evaluated the maximum tolerated dose of tirzepatide (TZP, 10 or 15 mg) versus placebo in participants with moderate-to-severe OSA and obesity. Study 1 included participants not on positive airway pressure (PAP) therapy, while participants in Study 2 were on PAP therapy. Post-hoc analyses grouped participants based on baseline PGIS Sleep Quality responses: “very poor/poor” (Poor SQ, N=138) or “fair/good/very good” (Good SQ, N=263). Changes in PROMIS SD scores from baseline to Week 52 were compared between TZP and placebo by subgroups based on mixed model repeated measure methods using on-treatment data. Patient Global Impression of Change (PGIC) Sleep Quality responses were also compared. Significant P-values are reported using “*” to denote values < 0.05. In Study 1 (N=194), placebo-adjusted changes from baseline with TZP treatment on the PROMIS-SD were -5.8* (Poor SQ) and -1.2 (Good SQ). Of participants treated with TZP with Poor SQ, 60.0% (N=12) reported their sleep quality as “A little better” or “much better,” compared to 20.0% (N=6) for those receiving placebo. For participants with Good SQ at baseline who were treated with TZP, 75.7% (N=56) reported improved sleep quality, compared to 29.8% (N=22) for those receiving placebo. In Study 2 (N=193), PROMIS-SD placebo-adjusted changes from baseline with TZP treatment were -3.9 (Poor SQ) and -4.7* (Good SQ). Among participants with Poor SQ who were treated with TZP, 55.8% (N=24) reported improved sleep quality, compared to 20% (N=9) for those receiving placebo. Similarly, 56.4% (N=35) of participants with Good SQ at baseline treated with TZP reported better sleep quality, compared to 28.3% (N=15) for those receiving placebo. Participants treated with TZP, not on PAP therapy, and with Poor SQ at baseline experienced greater improvements in PROMIS-SD compared to those with Good SQ. For those on PAP therapy, changes in PROMIS SD were similar across subgroups. Most participants reported improved sleep quality in both studies, regardless of baseline sleep quality.
Snoring is a common symptom of obstructive sleep apnea (OSA). Tirzepatide has previously shown improvements in the apnea hypoxia index, and it is hypothesized tirzepatide treatment may be associated with improvements in snoring in participants with obesity and moderate-to-severe OSA. Two phase 3 studies enrolled adults with moderate-to-severe OSA and obesity to evaluate the efficacy of tirzepatide at the maximum tolerated dose (10 or 15 mg) versus placebo. Study 1 (N=194) included adults who were not on positive airway pressure (PAP) therapy, while Study 2 (N=193) enrolled adults on PAP therapy. Participants completed Patient Global Impression of Status (PGIS) and Change (PGIC) assessments at baseline and Week 52, which measured overall sleep changes, including snoring, since starting the study drug. Post-hoc analyses categorized participants into subgroups based on PGIS baseline assessment of their snoring. The Baseline Non-snoring group was “not at all/slightly affected” by snoring, while the Baseline Snoring group was “moderately/very affected” by snoring. In participants not on PAP therapy (N: Snoring=91; Non-Snoring=103), a total of 68% (N=34) of participants treated with TZP in the Baseline Non-snoring group rated their sleep as “a little less affected” or “much less affected” by snoring, compared to 26.4% (N=14) of participants receiving placebo. For participants in the Baseline Snoring group, 62.8% (N=27) of participants treated with TZP noted the same improvement, compared to 20.9% (N=10) for placebo. In participants on PAP therapy (N: Snoring=106; Non-Snoring=87), PGIC results were similar, with 51.1% (N=24) of Baseline Non-Snoring participants treated with TZP rating their sleep as “a little less affected” or “much less affected” by snoring compared to 25.0% (N=10) of participants receiving placebo. For those in the Baseline Snoring group, 60.7% (N=31) of participants treated with TZP and 23.6% (N=13) of participants receiving placebo rated their sleep as “a little less affected” or “much less affected” by snoring. In these post hoc analyses, the majority of participants treated with TZP demonstrated improvements in snoring regardless of baseline severity or PAP treatment. Notably, over 60% of participants that reported being moderately or very affected by snoring at baseline showed improvements with TZP.
BACKGROUND Obstructive sleep apnea is characterized by disordered breathing during sleep and is associated with major cardiovascular complications; excess adiposity is an etiologic risk factor. Tirzepatide may be a potential treatment. METHODS We conducted two phase 3, double-blind, randomized, controlled trials involving adults with moderate-to-severe obstructive sleep apnea and obesity. Participants who were not receiving treatment with positive airway pressure (PAP) at baseline were enrolled in trial 1, and those who were receiving PAP therapy at baseline were enrolled in trial 2. The participants were assigned in a 1:1 ratio to receive either the maximum tolerated dose of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks. The primary end point was the change in the apnea-hypopnea index (AHI, the number of apneas and hypopneas during an hour of sleep) from baseline. Key multiplicity-controlled secondary end points included the percent change in AHI and body weight and changes in hypoxic burden, patient-reported sleep impairment and disturbance, highsensitivity C-reactive protein (hsCRP) concentration, and systolic blood pressure. RESULTS At baseline, the mean AHI was 51.5 events per hour in trial 1 and 49.5 events per hour in trial 2, and the mean body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) was 39.1 and 38.7, respectively. In trial 1, the mean change in AHI at week 52 was -25.3 events per hour (95% confidence interval [CI], -29.3 to -21.2) with tirzepatide and -5.3 events per hour (95% CI, -9.4 to -1.1) with placebo, for an estimated treatment difference of -20.0 events per hour (95% CI, -25.8 to -14.2) (P<0.001). In trial 2, the mean change in AHI at week 52 was -29.3 events per hour (95% CI, -33.2 to -25.4) with tirzepatide and -5.5 events per hour (95% CI, -9.9 to -1.2) with placebo, for an estimated treatment difference of -23.8 events per hour (95% CI, -29.6 to -17.9) (P<0.001). Significant improvements in the measurements for all prespecified key secondary end points were observed with tirzepatide as compared with placebo. The most frequently reported adverse events with tirzepatide were gastrointestinal in nature and mostly mild to moderate in severity. CONCLUSIONS Among persons with moderate-to-severe obstructive sleep apnea and obesity, tirzepatide reduced the AHI, body weight, hypoxic burden, hsCRP concentration, and systolic blood pressure and improved sleep-related patient-reported outcomes.
Background: Determining the self-efficacy perceptions of obstructive sleep apnea (OSA) patients has a key role in health care practices. With further evaluation, the Self-Efficacy Measure for Sleep Apnea (SEMSA) could serve as a useful scale to develop specific interventions to increase self-efficacy in patients with OSA during the acceptance and maintenance of continuous positive airway pressure (CPAP) therapy. Objective: The aim of this study is to translate the SEMSA into Turkish and to evaluate the psychometric properties of the translation. Methods: This cross-sectional study was carried out with a sample of patients recently diagnosed with CPAP-na & iuml;ve OSA. Linguistic and content validity of the scale were evaluated, while exploratory factor analysis and 2-level confirmatory factor analysis were used for validity. Internal consistency and test-retest methods were used in reliability analyses. Results: The mean (SD) age of the patients with OSA was 51.36 (11.29), and 68% were male. The item factor loads obtained as a result of the confirmatory factor analysis ranged from 0.44 to 0.94, confirming the three-factor structure of the instrument. The Cronbach's alpha coefficient of the scale was found to be 0.90. Measurements made within the scope of test-retest analysis were found to be related and consistent results were obtained in the intervening time (P < .01). Conclusions: In this study, the Turkish version of SEMSA was found to be a valid and reliable tool and it could be used to evaluate the adherence-related cognition in Turkish patients with OSA on CPAP therapy.
Objective: Perform the validation and psychometric evaluation of the Brazilian-Portuguese translation of the Functional Outcome of Sleep Questionnaire 10 (FOSQ10). Materials and methods: 182 patients (65 females 48.3 +/- 14.4 years and 117 males 46.9 +/- 12.4 years), were evaluated by sleep physicians suspected of having Obstructive Sleep Apnea, underwent polysomnography and completed the FOSQ-10 and the Epworth Sleepiness Scale. APA & NCME, 2014 was used to validate the data as the American Educational Research Association recommended. Results: Quality indicators such as Bartlett's test of sphericity (chi(2) = 1108.2; gL = 45; p = 0.000010) and KMO (0.83), and adherence measures, attest to the quality of the model. The indicators TLI (0.97), CFI (0.98), and RMSEA (0.04) fall within the expected values. Using the Eigenvalue > 1 technique, two factors explain 53% and 13.3% of the variances. In the Parallel Analysis technique, a single factor explained 59.4653% of the random variance, and the Unidimensionality indicators UniCo = 0.921, ECV = 0.822, and MIREAL = 0.253, were supported. Construct Validity: reliability coefficients Cronbach's alpha = 0.87, McDonald's ordinal Omega index 0.9, and the Composite Reliability 0.891 were satisfactory. Convergent validity: There was a significant Spearman correlation between FOSQ-10 and the Epworth Sleepiness Scale (r = 0.364 [-0.487; -0.226]). Criterion validity: Was not possible to differentiate the groups based on the severity of AHI using FOSQ-10P. Conclusions: The Brazilian translation of FOSQ-10 is valid and reliable for identifying significant effects of excessive daytime sleepiness in patients with Obstructive Sleep Apnea.
Acute stress, post-traumatic stress and burnout are all stress-related mental health problems common to patients, families, physicians, nurses, and allied health professionals across disciplines. They are particularly common in those who care for critically ill and injured children. Despite growing awareness of the pervasiveness of burnout and stress among healthcare workers and families in the pediatric intensive care unit, there remain important gaps in the knowledge of factors affecting the development of stress-related mental illnesses, how individual and institutional factors protect or exacerbate these problems, and effective measures to limit or mitigate them. Challenges exist in developing and maintaining institutional engagement with essentially non-revenue generating activities that require additional staff. For academic institutions, significant opportunities exist for cross-departmental collaboration. We describe our five-year experience developing a multidisciplinary group investigating these problems and providing interventions to professionals and families in the pediatric intensive care unit.
Objectives: Food and Alcohol Disturbance (FAD) is the phenomenon in which individuals exhibit co-occurring hazardous alcohol and eating behaviors to either negate caloric intake associated with alcohol and/or maximize intoxication. While the Compensatory Eating and Behaviors in Response to Alcohol Scale (CEBRACS) is the most widely used measure to assess FAD to date, its factor-structure has yet to be confirmed. Methods: The current study utilized confirmatory factor analysis (CFA) to examine the CEBRACS' four factor subscales as well as recently proposed alternative scoring structures. Participants: Participants (N = 582) were American college students from seven universities (18-24 years; 67% cisgender women; 70% non-Hispanic White). Results: The CFA failed to provide optimal fit for all models tested. Results of invariance testing found no measurement variance by sex, suggesting the failure of the four-factor solution was not due to noninvariance. Conclusions: Overall, findings do not support continued use of the original 21-item CEBRACS.
Background: Weight reduction is a standard recommendation for obstructive sleep apnea (OSA) treatment in people with obesity or overweight; however, weight loss can be challenging to achieve and maintain without bariatric surgery. Currently, no approved anti-obesity medication has demonstrated effectiveness in OSA management. This study is evaluating the efficacy and safety of tirzepatide for treatment of moderate to severe OSA in people with obesity. Methods: SURMOUNT-OSA, a randomized, placebo -controlled, 52-week phase 3 trial, is investigating the efficacy and safety of tirzepatide for treatment of moderate to severe OSA (apnea hypopnea- index >= 15 events/h) in participants with obesity (body mass index >= 30 kg/m2) and an established OSA diagnosis. SURMOUNT-OSA is made of 2 intervention-specific appendices (ISAs): ISA-1 includes participants with no current OSA treatment, and ISA-2 includes participants using positive airway pressure therapy. Overall, 469 participants have been randomized 1:1 to receive tirzepatide or placebo across the master protocol (ISA-1, n = 234; ISA-2, n = 235). All participants are also receiving lifestyle intervention for weight reduction. Results: The primary endpoint for the individual ISAs is the difference in apnea hypopnea- index response, as measured by polysomnography, between tirzepatide and placebo arms at week 52. Secondary endpoints include sleep apnea-specific hypoxic burden, functional outcomes, and cardiometabolic biomarkers. The trial employs digital wearables, including home sleep testing to capture time to improvement and accelerometry for daily physical activity assessment, to evaluate exploratory outcomes. Conclusion: SURMOUNT-OSA brings a novel design to investigate if tirzepatide provides clinically meaningful improvement in obesity-related OSA by targeting the underlying etiology. Trial registration: ClinicalTrials.gov, NCT05412004
Background and Objectives: This study aims to examine the factors affecting the daily functioning of patients with obstructive sleep apnea (OSA). Materials and Methods: In addition to the polysomnography records of 361 patients, participants completed the Turkish FOSQ-10 (Functional Outcomes of Sleep-10), Medical Outcome Survey Short Form-12, Epworth Sleepiness Scale (ESS), Beck Depression Inventory (BDI), and Beck Anxiety Inventory (BAI). First, the psychometrics properties of the Turkish FOSQ-10 were evaluated. Then, factors affecting daily functioning were examined through univariate and multivariate analyses. Results: Of all participants, 68.7% (n = 248) were male, and the average age was 47.94 ± 11.08. According to the OSA category, 23% (n = 83) were mild, 22.7% (n = 82) were moderate, 45.2% (n = 163) were severe, and 9.1% (n = 33) were OSA negative. The Turkish FOSQ-10 was found to be a valid and reliable scale through validity and reliability analyses. The moderate and severe OSA patients had different FOSQ-10 Total scores compared to the negative OSA group. Daily functioning was positively associated with overall quality of life while inversely associated with depression, being anxious, and daytime sleepiness in OSA patients. In a multiple regression model, BDI, mental component summary-12, physical component summary-12, and ESS scores were significantly related to the FOSQ-10 Total score in OSA patients (p < 0.05). Conclusions: The daily functioning of moderate and severe OSA patients was worse than that of the negative OSA group. Depression, quality of life, and daytime sleepiness were simultaneously important variables associated with daily functioning in OSA patients.
OBJECTIVE:Contemporary theories conceptualize the anniversary of a traumatic event as a trauma reminder capable of activating posttraumatic stress disorder (PTSD) symptoms. The current study uses the cognitive stress and growth model to examine this model's usefulness in characterizing anniversary reactions.METHOD:Participants (N = 197) were MTurk workers who endorsed an "emotionally charged reaction on or near the anniversary of a tragic event." They completed assessments of PTSD, posttraumatic growth (PTG), sense of control, rumination, and trauma centrality.RESULTS:Multiple regression analyses found both anniversary-related stress and PTSD symptoms were associated with similar factors with similar magnitude across both outcomes. Trauma centrality was uniquely associated with anniversary-related PTG.CONCLUSIONS:Anniversaries marked by stress are characterized by factors similar to PTSD generally, but growth-related reactions have different correlates compared to PTG outside the reaction. These findings suggest the anniversary period may be a time of self-reflection about the event and its impact.
Childhood maltreatment is associated with significant psychological distress and coping-related maladaptive behaviors that can extend into adulthood. Non-suicidal self-injury is one form of maladaptive coping characterized by engaging in the commission of self-harm. This study explored if coping with childhood maltreatment may manifest in different forms, including behavioral omission in which an individual harms themselves through a lack of self-care. We proposed the novel construct of self-deprivation as an omissive self-harming behavior. Self-deprivation is defined as engaging in low levels of self-care motivated by an intent to harm oneself. One hundred twenty adults (72
Abstract Introduction Weight reduction is a standard recommended component of OSA treatment in people with obesity or overweight; however, the challenge to achieve and maintain weight reduction has limited its clinical application outside of the benefit established after bariatric surgery. Currently no FDA-approved anti-obesity medication (AOM) has demonstrated clinically meaningful improvement in OSA severity and symptomology. Methods Tirzepatide is a single molecule GIP and GLP-1 receptor agonist. In SURMOUNT-1, a 72-week phase 3 clinical trial in participants with obesity or overweight, tirzepatide 15mg provided average reductions in body weight of 22.5% which occurred with beneficial effects on blood pressure, lipids, and physical functioning. In a linear meta regression model, we estimated that tirzepatide treatment would provide clinically meaningful apnea-hypopnea index decrease compared to placebo-treated participants with obesity and OSA. SURMOUNT-OSA, a placebo controlled 52-week, phase 3 trial, will investigate efficacy and safety of tirzepatide for the treatment of moderate to severe OSA (defined as AHI ≥15) in participants with obesity. SURMOUNT-OSA utilizes an umbrella master protocol and 2 Intervention-Specific Appendices (ISAs): ISA 1 includes participants with no current OSA treatment and ISA 2 includes participants using positive airway pressure therapy. Approximately 412 participants will be randomly assigned to placebo or tirzepatide across the entire master protocol, with approximately 206 participants in each ISA. While participants will receive tirzepatide or placebo based on a 1:1 randomization ratio, all participants will receive background lifestyle intervention for weight reduction. Results The primary endpoint for the individual ISAs is the difference in AHI response measured by polysomnography between tirzepatide and placebo arms at week 52. Secondary endpoints include hypoxic burden, functional outcomes and cardiometabolic biomarkers. The trial is utilizing a unique hierarchical functional outcomes endpoint based on Functional Outcomes of Sleep Questionnaire methodology. The trial employs wearables, such as home sleep testing and accelerometry to capture time to improvement as exploratory outcomes. Conclusion SURMOUNT-OSA aims to explore whether tirzepatide provides clinically meaningful improvement in obesity-related OSA by targeting an underlying etiology. Support (if any) Eli Lilly
Quality of life (QoL) is one of the outcomes that can be measured as a component of the required standards for sleep facility accreditation by the American Academy of Sleep Medicine. Utilization of a psychometrically robust QoL instrument is recommended; however, clinicians face a challenge balancing psychometric properties with questionnaire completion and scoring characteristics. This article provides an overview of common QoL instruments as a reference for clinicians when selecting a QoL tool for use in the clinical setting for adult patients with obstructive sleep apnea.
Background: Positive airway pressure (PAP) is a highly effective treatment for obstructive sleep apnea (OSA), but adherence limits its efficacy. In addition, coverage of PAP by CMS (Centers for Medicare & Medicaid Services) and other insurers in the United States depends on adherence. This leaves many beneficiaries without PAP, disproportionally impacting non-white and low socioeconomic position patients with OSA and exacerbating sleep health disparities. Methods: An inter-professional, multidisciplinary, international committee with various stakeholders was formed. Three working groups (the historical policy origins, impact of current policy, and international PAP coverage models) met and performed literature reviews and discussions. Using surveys and an iterative discussion-based consensus process, the policy statement recommendations were created. Results: In this position paper, we advocate for policy change to CMS PAP coverage requirements to reduce inequities and align with patient-centered goals. We specifically call for eradicating repeat polysomnography, eliminating the 4-hour rule, and focusing on patient-oriented outcomes such as improved sleepiness and sleep quality. Conclusions: Modifications to the current policies for PAP insurance coverage could improve health disparities.