Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity.

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, high-sensitivity 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. (Funded by Eli Lilly; SURMOUNT-OSA ClinicalTrials.gov number, NCT05412004.).

Moving toward Equitable Care for Sleep Apnea in the United States: Positive Airway Pressure Adherence Thresholds: An Official American Thoracic Society Policy Statement.

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.

Institutional Experience with Investigation and Service for Acute and Post-Traumatic Stress in the Pediatric Intensive Care Unit.

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.

Relationship between sleep efficacy endpoints and measures of functional status and health-related quality of life in participants with narcolepsy or obstructive sleep apnea treated for excessive daytime sleepiness.

This study examined the correlation between improvements in excessive daytime sleepiness in participants with obstructive sleep apnea or narcolepsy and changes in functional status, work productivity and health-related quality of life. Data from two 12-week randomized controlled trials of solriamfetol were analyzed. Participants completed the Epworth Sleepiness Scale, 10-item Functional Outcomes of Sleep Questionnaire, Work Productivity and Activity Impairment questionnaire and 36-Item Short Form Health Survey and performed the Maintenance of Wakefulness Test at baseline and weeks 4, 8 and 12. Patient Global Impression of Change was assessed at weeks 4, 8 and 12. Pearson correlations were calculated for change in scores from baseline to week 12. For both studies, changes in the 10-item Functional Outcomes of Sleep Questionnaire were highly correlated (absolute value >0.5) with changes in Epworth Sleepiness Scale scores; changes in multiple domain scores of the 36-Item Short Form Health Survey and Work Productivity and Activity Impairment questionnaire were moderately correlated (0.3-0.5) with changes in Epworth Sleepiness Scale scores in both studies and highly correlated for participants with narcolepsy. Changes in Maintenance of Wakefulness Test scores correlated moderately with changes in Epworth Sleepiness Scale scores in both studies. At week 12, Patient Global Impression of Change ratings correlated highly with Epworth Sleepiness Scale and 10-item Functional Outcomes of Sleep Questionnaire scores for both disorders. Other correlations were low. Self-reported assessments of sleepiness and global improvement appear to be more strongly correlated with measures of functioning and health-related quality of life than objectively assessed sleepiness.

Determination of thresholds for minimally important difference and clinically important response on the functional outcomes of sleep questionnaire short version in adults with narcolepsy or obstructive sleep apnea.

PURPOSE: This study estimated thresholds for clinically important responses and minimally important differences for two indicators of improvement for the 10-item version of the functional outcomes of sleep questionnaire (FOSQ-10). METHODS: Participants with excessive daytime sleepiness with narcolepsy or obstructive sleep apnea received 12 weeks of solriamfetol treatment. Participants completed the FOSQ-10 and other patient-reported outcome measures, including the single-item patient global impression of change (PGI-C) assessment. Clinicians completed the single-item clinician global impression of change (CGI-C) for each participant. Data from the two studies were analyzed separately, both without regard to treatment assignment. In total, 690 participants (47% female, mean age 48 years, 77% Caucasian, 91% from North America) were enrolled. Two clinically important changes, defined as a minimally important difference and a clinically important response, were determined using distribution and anchor-based analyses. A receiver operating characteristic analysis was used to determine the optimal FOSQ-10 change threshold. RESULTS: Spearman correlations between change in FOSQ-10 scores and PGI-C and CGI-C were - 0.57 and - 0.49 for participants with narcolepsy and - 0.42 and - 0.37 for participants with obstructive sleep apnea. Receiver operating characteristic analysis suggested minimally important difference and clinically important response estimates of 1.7 and 2.5 and 1.8 and 2.2 points in narcolepsy and obstructive sleep apnea, respectively. CONCLUSIONS: Minimally important difference and clinically important response estimates for the FOSQ-10 for adults with excessive daytime sleepiness in narcolepsy or obstructive sleep apnea will be helpful for interpreting changes over time and defining a clinical responder. CLINICALTRIALS. GOV IDENTIFIERS: NCT02348593 (first submitted January 15, 2015) and NCT02348606 (first submitted January 15, 2015).

The Efficacy of Binaural Beats as a Stress-buffering Technique.

CONTEXT: Distress has deleterious effects on health. While complementary and alternative medicine (CAM) is a growing system of practices in the treatment of health and mental-health conditions, many individuals have limited access to mind-body interventions. Creating accessible stress-inoculation strategies may augment traditional mental-health interventions and services. OBJECTIVE: This pilot study intended to assess the effectiveness of a theta binaural beat (TBB) auditory stimulus on heart rate and self-reported stress, which was experimentally induced by the Trier Social Stress Test (TSST). DESIGN: The repeated measures study compared the stress levels after a stimulus and stressor for two groups, within an experimentally induced psychological stress paradigm, the Trier Social Stress Test (TSST). SETTING: The study occurred at a private Midwestern university. PARTICIPANTS: Participants were 64 US adults recruited from undergraduate classes at the university, with a mean age of 19 years and a range from 18 to 30. INTERVENTION: Participants were randomly assigned to the intervention or the control group. The intervention group listened to pink sound, carrier tones, and embedded TBB, while the control group listened to pink sound and carrier tones without embedded TBB. OUTCOME MEASURES: Participants completed self-report assessments about the auditory stimulus, perceived stress, and mindfulness and then engaged in the Trier Social Stress Test (TSST). Subsequently, they completed measures on perceived stress using a visual analogue scale (VAS), and heart rate variability (HRV) was recorded throughout the study. RESULTS: With respect to the evaluation of subjective stress using the VAS, psychological stress increased significantly between the exposure to the stimuli and the TSST-F(1.28, 53) = 42.76, P = .01, partial η2 = 0.44. The change in stress levels for the intervention group, however, was not significantly different from that of the control group at any time point F(1.28, 53) = 1.03, P = .33, partial η2 = 0.02. With respect to the evaluation of physiological response to stress using the HRV, the changes in HF HRV between the 4, five-minute segments during stimulus exposure were not significantly different between the groups F(3, 55) = 0.90, P = .44, partial η2 = 0.02. A significantly greater change-F(1, 55) = 4.84, P = .03 partial η2 = 0.08-in the HF HRV occurred over the TSST period for the intervention group compared to the control group suggesting that on average across the TSST stress tasks, those in the intervention group demonstrated higher HF signals. CONCLUSIONS: The current study found that the intervention group, who listened to TBBs, had greater parasympathetic dominance during TSST than the control group. This suggests that TBB exposure may dampen subsequent stress responses to an acute, psychological stressor. This finding, however, should be interpreted with caution, because further research and independent replication are warranted.

Testing Cognitive Models to Characterize Trauma Anniversary Reactions Marked by Stress and Growth.

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.

A French update on the Self-Efficacy Measure for Sleep Apnea (SEMSA) to assess continuous positive airway pressure (CPAP) use.

PURPOSE: The Self-Efficacy Measure for Sleep Apnea (SEMSA) is a 26-item self-questionnaire composed of three factors: risk perception of obstructive sleep apnea syndrome (OSAS), benefit of continuous positive airway pressure (CPAP), and self-efficacy (the confidence to engage in CPAP use). It is used to evaluate health beliefs about OSAS and CPAP in order to optimize CPAP use. The purpose of this study was to design and validate a French version of the SEMSA. METHODS: A forward-backward translation of the SEMSA was performed. Subjects with OSAS treated by CPAP and followed by our sleep clinic were invited to complete the questionnaire. The psychometric properties of the French SEMSA version were analyzed in terms of its construct validity (with confirmatory factor analysis, CFA), internal structural validity (Cronbach's alpha coefficient), and external validity (Pearson's correlation between SEMSA score and duration of CPAP use). RESULTS: Two hundred eighty-eight subjects filled in the questionnaire. The mean age was 63.16 ± 12.73 years. The number of years since the beginning of CPAP treatment was 6.58 ± 6.03 years. The mean CPAP use duration was 6.19 ± 2.03 h/night. CFA was unsatisfactory (RMSEA = 0.066 and CFI = 0.88). The exploratory factor analysis revealed a fourth factor named "cardiovascular risk" factor. Cronbach's alpha coefficient was 0.886. The correlation between the "self-efficacy" factor and the duration of CPAP use was significant (r = 0.26, p ≤ 0.001). CONCLUSIONS: The French version of the SEMSA is a psychometrically acceptable self-report questionnaire for measuring health beliefs and behavior in French patients with OSAS treated with CPAP. Such translation and validation should lead to the adoption of validated psychosocial methods for improving CPAP use.

A Tailored Intervention for PAP Adherence: The SCIP-PA Trial.

OBJECTIVE/BACKGROUND: Positive airway pressure (PAP) is highly efficacious treatment but nonadherence is prevalent with little improvement over the last 15 years. Tailored interventions show promise for promoting adherence to other treatments. The study objective was to examine feasibility and acceptability of a tailored intervention to promote PAP adherence. PARTICIPANTS: The convenience sample met inclusion criteria: newly diagnosed OSA; treatment-naïve; ≥ 18 years. EXCLUSION CRITERIA: previous obstructive sleep apnea (OSA) diagnosis and treatment; new psychiatric diagnosis; use of oxygen/bilevel PAP; secondary sleep disorder. Adults (n = 118) were randomized to tailored intervention (TI; n = 61) or usual care (UC; n = 57); application of a priori exclusion criteria resulted in 30 participants per assignment who were middle-aged (51.3 ± 11.1 years) adults (70% male) with severe OSA (apnea hypopnea index [AHI], 35.9 ± 25.2). METHODS: Randomized, double-blind, single-site pilot controlled trial. A multiphased tailored intervention targeting social cognitive perceptions of OSA-PAP treatment was delivered at four intervals. Descriptive analysis, group differences, and self-efficacy change scores by t-test, and thematic analysis of acceptability data are reported. RESULTS: One-week PAP use among TI was 35 min greater than UC condition (p = 0.20; Cohen's d = 0.336). Treatment use decreased at 1 month and 3 months (NS). Per-protocol delivery of face-to-face intervention delivery was 100% but lower for telephone intervention delivery. Personalized approach was valued by participants. CONCLUSIONS: A tailored intervention approach is acceptable to participants and feasibly implemented in a clinical sleep center setting. The intervention effect size at 1 week is consistent with other educational PAP adherence interventions but was not sustained; further pilot testing is warranted to address pilot RCT limitations.

Update on Research and Practices in Major Sleep Disorders: Part II-Insomnia, Willis-Ekbom Disease (Restless Leg Syndrome), and Narcolepsy.

PURPOSE: This review (Part II of a series on sleep disorders) presents an update of the characteristics, epidemiology, assessment, and latest management of insomnia, restless legs syndrome (Willis-Ekbom disease; RLS/WED), and narcolepsy. Insomnia, the most common sleep disorder and most prevalent of all psychological health disorders, is a problem of difficulty initiating and maintaining sleep and early morning awakenings. RLS/WED is characterized by a crawling sensation or urge to move the legs in the evening and nighttime. Narcolepsy is a sleep disorder that commonly results in chronic daytime sleepiness and cataplexy. Nonpharmacological management, which includes education, cognitive behavioral therapy, and complementary therapy, is used as primary or adjunctive to pharmacotherapy for the treatment of these disorders. METHODS: This narrative review utilized medical databases such as PubMed to identify relevant English-language original and systematic review articles predominantly from peer-reviewed journals from 2012 to 2019. However, as background, findings from classic articles prior to 2012 were also included. CLINICAL RELEVANCE: Assessment of sleep problems, excessive sleepiness, and difficulty performing activities or being productive should be routine in the care of all patients. Utilization of behavioral interventions, including cognitive behavioral therapy, in addition to education and sleep hygiene, can promote sleep quality. Management of insomnia, RLS/WED, and narcolepsy should include helping patients adjust to treatment, managing cataplexy triggers in narcolepsy, and initiating strategies to live with chronic illness to improve quality of life.

Update on Research and Practices in Major Sleep Disorders: Part I. Obstructive Sleep Apnea Syndrome.

PURPOSE: The purpose of this first of two review articles providing an update on sleep disorders was to examine the pathophysiology, epidemiology, and treatment of obstructive sleep apnea (OSA). OSA is a common sleep disorder whose prevalence is similar to asthma. As with other sleep disorders, OSA has a broad impact on individuals, affecting their daily behaviors, cognitive abilities, and performance, and putting them at increased risk for accidents, mood disorders, cancer, cardiovascular disease, and hypertension. Thus, early recognition and management, much of which can be implemented by nurses, can reduce health and accident risks and improve daily functioning. METHODS: This narrative review utilized medical databases such as PubMed to identify relevant English language original and systematic review articles predominantly from peer-reviewed journals from 2012 to 2018. However, as background, findings from classic articles prior to 2012 were also included. CLINICAL RELEVANCE: OSA is a common condition with considerable impact on daily functioning and potential for accidents and serious comorbidities such as hypertension, cardiovascular disease, diabetes, and depressed mood. The impairments and comorbidities associated with OSA can be reduced through early detection, encouraging treatment, providing education about sleep and OSA, and, importantly, promoting adherence to the predominant therapy, positive airway pressure.

Criteria for gauging response to sodium oxybate for narcolepsy.

Our objective was to define responder criteria using an anchor-based approach for frequency of cataplexy attacks and excessive daytime sleepiness in patients with narcolepsy undergoing sodium oxybate treatment. We used pooled data from two randomized, placebo-controlled, double-blind, multicentre 4- and 8-week trials of sodium oxybate for narcolepsy with cataplexy and analysed using receiver operator characteristics analysis. The percentage change in frequency of weekly cataplexy attacks and the Epworth Sleepiness Scale outcomes were compared with Clinical Global Impression of Change ratings, used as the anchor to define true response. Participants (n = 336) were 39% male, 89% white, with a mean age of 41.5 (15.3) years, reporting a median of 20.5 cataplexy attacks per week and a mean Epworth Sleepiness score of 17.5 at baseline. A majority (51%) were Much Improved or Very Much Improved based on Clinical Global Impression of Change ratings, considered a true response to treatment. Area under the curve values for % reduction in cataplexy attacks (77%) and % change in sleepiness score (78%) supported response definition thresholds of 46% and 12%, respectively. Classification using either response definition agreed with the anchor for approximately 71% of participants. Cataplexy response definition was more sensitive (cataplexy = 0.77, Epworth Sleepiness Scale = 0.69), while sleepiness was more specific (cataplexy = 0.66, Epworth Sleepiness Scale = 0.75). Both responder definitions showed a dose-response relationship with sodium oxybate, demonstrating their validity using an external criterion. Weekly cataplexy attacks and Epworth Sleepiness Scale can be used to help document clinical response to narcolepsy treatment using criteria of 46% and 12% reductions, respectively.

Brain white matter changes in CPAP-treated obstructive sleep apnea patients with residual sleepiness.

PURPOSE: To investigate white matter (WM) structural alterations using diffusion tensor imaging (DTI) in obstructive sleep apnea (OSA) patients, with or without residual sleepiness, following adherent continuous positive airway pressure (CPAP) treatment. Possible quantitative relationships were explored between the DTI metrics and two clinical assessments of somnolence. MATERIALS AND METHODS: Twenty-nine male patients (30-55 years old) with a confirmed diagnosis of OSA were recruited. The patients were treated with CPAP therapy only. The Psychomotor Vigilance Task (PVT) and Epworth Sleepiness Scale (ESS) were performed after CPAP treatment and additionally administered at the time of the magnetic resonance imaging (MRI) scan. Based on the PVT results, the patients were divided into a nonsleepy group (lapses ≤5) and a sleepy group (lapses >5). DTI was performed at 3T, followed by an analysis using tract-based spatial statistics (TBSS) to investigate the differences in fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (λ1 ), and radial diffusivity (λ23 ) between the two groups. RESULTS: A higher MD (P < 0.05) was observed in the sleepy group than the nonsleepy group in the whole-brain TBSS analysis in the WM. The increased MD (17.8% of the fiber tracts; P < 0.05) was caused primarily by an elevated λ23 . Axial diffusivity (λ1 ) exhibited no significant difference (P > 0.17). The alterations in FA or MD of individual fiber tracts occurred mainly in the internal/external capsule, corona radiata, corpus callosum, and sagittal stratum regions. The FA and MD values correlated with the PVT and ESS assessments from all patients (R ≥ 0.517, P < 0.05). CONCLUSION: Global and regional WM alterations, as revealed by DTI, can be a possible mechanism to explain why OSA patients with high levels of CPAP use can have differing responses to treatment. Compromised myelin sheath, indicated by increased radial diffusivity, can be involved in the underlying WM changes. Evidence level: 1 J. MAGN. RESON. IMAGING 2017;45:1371-1378.

A pathway underlying the impact of CPAP adherence on intimate relationship with bed partner in men with obstructive sleep apnea.

PURPOSE: Our aim was to determine the pathway underlying the effects of continuous positive airway pressure (CPAP) adherence on intimate relationship with bed partner in men with obstructive sleep apnea (OSA). We hypothesized that CPAP with good adherence affected the intimate relationship with bed partner directly and indirectly, and it was mediated through daytime sleepiness and activity level in men with OSA. METHODS: Data were obtained from an education program for enhancing CPAP adherence. Men who were newly diagnosed of OSA and CPAP therapy naïve were recruited in a tertiary teaching hospital. RESULTS: Self-reported quality of life [Functional Outcomes of Sleep Questionnaire], daytime sleepiness [Epworth Sleepiness Scale (ESS)], and negative emotion symptoms [depression, anxiety, stress scale] were assessed before and after CPAP treatment at 1-year assessment. Seventy-three men were included in the data analysis, with a mean ± SD age of 52 ± 10 years, body mass index of 29.0 ± 5.2 kg/m(2), ESS of 9.5 ± 5.6, and median [interquartile range(IR)] apnea and hypopnea index of 31 (21, 56) events/h. The median (IR) CPAP daily usage was 4.3(0, 6.1) h/day. From the path analysis, CPAP therapy was shown to improve intimate relationship directly (ß = 0.185) and indirectly (ß = 0.050) by reducing daytime sleepiness and increasing activity level. However, negative emotion symptoms were not the mediators between CPAP adherence and the intimate relationship. CONCLUSIONS: CPAP therapy with good adherence is related directly and indirectly to a better intimate relationship with bed partner in men with OSA. It was possibly attributed to reduced daytime sleepiness and increased activity level.

Impaired sustained attention and lapses are present in patients with mild obstructive sleep apnea.

BACKGROUND: Severe obstructive sleep apnea (OSA) directly affects the quality of life, mood, and sustained attention of individuals, but it has not yet been established in the literature, if these changes also affect patients with mild OSA. The purpose of this study was to investigate such negative effects on the parameters described above. METHODS: A controlled study was held at the Universidade Federal de Sao Paulo, Department of Psychobiology. Thirty-nine mild OSA patients and 25 controls were included. Volunteers could be of both genders with body mass index (BMI) ≤35 kg/m(2) and age between 18 and 65 years. Both groups were subjected to full-night polysomnography (PSG), the subjective assessment of mood (Beck Inventory of Anxiety and Depression), Functional Outcomes of Sleep Questionnaire (FOSQ), and the psychomotor vigilance task (PVT) five times during the day. We considered mild OSA patients those with apnea-hypopnea index (AHI) score between 5 and 15. The control group included subjects with AHI scores <5, respiratory disturbance index (RDI) scores ≤5, arousal index values ≤15, and Epworth Sleepiness Scale (ESS) values ≤9. RESULTS: Mild OSA patients were older and more obese than the controls. After adjusting for age, BMI, and schooling years, there was an increased number of total lapses (3.90 ± 4.16 and 2.43 ± 5.55, p = 0.004). CONCLUSIONS: Patients with mild OSA showed increased sustained attention lapses compared with normal subjects.

Validation of the Chinese Version of the Functional Outcomes of Sleep Questionnaire-10 in Pregnant Women.

We evaluated the psychometric properties of a Mandarin Chinese version of the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) in pregnant women. A total of 228 first-trimester pregnant women participated in the study, which was conducted in an outpatient obstetric clinic at a medical center in Taipei, Taiwan. The Chinese version of the FOSQ-10 demonstrated satisfactory internal consistency (Cronbach alpha = .85), adequate corrected item-total correlations (from .40 to .67), and acceptable test-retest reliability over 7 days (ICC = .73). Construct validity was supported by exploratory factor analysis showing a one-factor structure with item loadings between .49 and .77. Significant associations with the Medical Outcomes Study Short-Form Health Survey 12 version 2 and Pittsburgh Sleep Quality Index supported criterion-related and convergent validity. Significant differences in the Chinese version of the FOSQ-10 total scores were found between women with clinically significant daytime sleepiness and those without, suggesting adequate discriminant validity. Ceiling effects were observed for all items, but no floor or ceiling effects were found for total scores. Findings suggest that the Chinese version of the FOSQ-10 is a valid and reliable instrument to identify important effects of sleep-related impairment in Chinese women during pregnancy. Further testing is needed in more diverse pregnant women, such as women with complicated pregnancies and those with sleep disorders. © 2016 Wiley Periodicals, Inc.

The effect of bright light therapy on sleep and circadian rhythms in renal transplant recipients: a pilot randomized, multicentre wait-list controlled trial.

This study assessed the effect and feasibility of morning bright light therapy (BLT) on sleep, circadian rhythms, subjective feelings, depressive symptomatology and cognition in renal transplant recipients (RTx) diagnosed with sleep-wake disturbances (SWD). This pilot randomized multicentre wait-list controlled trial included 30 home-dwelling RTx randomly assigned 1:1 to either 3 weeks of BLT or a wait-list control group. Morning BLT (10 000 lux) was individually scheduled for 30 min daily for 3 weeks. Wrist actimetry (measuring sleep and circadian rhythms), validated instruments (subjective feelings and cognition) and melatonin assay (circadian timing) were used. Data were analysed via a random-intercept regression model. Of 30 RTx recipients (aged 58 ± 15, transplanted 15 ± 6 years ago), 26 completed the study. While BLT had no significant effect on circadian and sleep measures, sleep timing improved significantly. The intervention group showed a significant get-up time phase advance from baseline to intervention (+24 min) [(standardized estimates (SE): -0.23 (-0.42; -0.03)] and a small (+14 min) but significant bedtime phase advance from intervention to follow-up (SE: -0.25 (-0.41; -0.09). Improvement in subjective feelings and depressive symptomatology was observed but was not statistically significant. Bright light therapy showed preliminary indications of a beneficial effect in RTx with sleep-wake disturbances. (ClinicalTrials.gov number: NCT01256983).

Daytime sleepiness in renal transplant recipients is associated with immunosuppressive non-adherence: a cross-sectional, multi-center study.

BACKGROUND: The aims of this study were to determine the prevalence of immunosuppressive non-adherence (NA) in renal transplant patients and describe whether the degree of daytime sleepiness (DS) and depressive symptomatology are associated with immunosuppressive NA. METHODS: Using a cross-sectional design, 926 home-dwelling renal transplant recipients who were transplanted at one of three Swiss transplant centers provided data by self-report. The Basel Assessment of Adherence Scale for immunosuppressive was used to measure the following: taking, timing, and overall NA to immunosuppressive medication. DS was assessed with the Epworth Sleepiness Scale (ESS) (cut-off ≥6 for DS) and the Swiss Transplant Cohort Study DS item (cut-off ≥4 for DS), and depressive symptomatology was assessed with the Depression, Anxiety, and Stress Scale (cut-off>10). An ordinal logistical regression model was applied for statistical analysis. RESULTS: The prevalence of the ESS-DS was 51%. NA for taking, timing, and the median overall NA level assessed by 0-100% visual analog scale (VAS) was 16%, 42%, and 0%, respectively. Based on the multivariate analysis, DS was significantly associated (p < 0.001) with taking (1.08 [1.04-1.13]), timing (1.07 [1.03-1.10]), and overall NA (1.09 [1.05-1.13]). Very similar results were found for the Swiss Transplant Cohort Study DS item. CONCLUSION: DS is associated with immunosuppressive medication NA in renal transplant recipients. Admittedly, the association's strength is limited.

An official American Thoracic Society Clinical Practice Guideline: sleep apnea, sleepiness, and driving risk in noncommercial drivers. An update of a 1994 Statement.

BACKGROUND: Sleepiness may account for up to 20% of crashes on monotonous roads, especially highways. Obstructive sleep apnea (OSA) is the most common medical disorder that causes excessive daytime sleepiness, increasing the risk for drowsy driving two to three times. The purpose of these guidelines is to update the 1994 American Thoracic Society Statement that described the relationships among sleepiness, sleep apnea, and driving risk. METHODS: A multidisciplinary panel was convened to develop evidence-based clinical practice guidelines for the management of sleepy driving due to OSA. Pragmatic systematic reviews were performed, and the Grading of Recommendations, Assessment, Development, and Evaluation approach was used to formulate and grade the recommendations. Critical outcomes included crash-related mortality and real crashes, whereas important outcomes included near-miss crashes and driving performance. RESULTS: A strong recommendation was made for treatment of confirmed OSA with continuous positive airway pressure to reduce driving risk, rather than no treatment, which was supported by moderate-quality evidence. Weak recommendations were made for expeditious diagnostic evaluation and initiation of treatment and against the use of stimulant medications or empiric continuous positive airway pressure to reduce driving risk. The weak recommendations were supported by very low-quality evidence. Additional suggestions included routinely determining the driving risk, inquiring about additional causes of sleepiness, educating patients about the risks of excessive sleepiness, and encouraging clinicians to become familiar with relevant laws. DISCUSSION: The recommendations presented in this guideline are based on the current evidence, and will require an update as new evidence and/or technologies becomes available.

An official American Thoracic Society statement: continuous positive airway pressure adherence tracking systems. The optimal monitoring strategies and outcome measures in adults.

BACKGROUND: Continuous positive airway pressure (CPAP) is considered the treatment of choice for obstructive sleep apnea (OSA), and studies have shown that there is a correlation between patient adherence and treatment outcomes. Newer CPAP machines can track adherence, hours of use, mask leak, and residual apnea-hypopnea index (AHI). Such data provide a strong platform to examine OSA outcomes in a chronic disease management model. However, there are no standards for capturing CPAP adherence data, scoring flow signals, or measuring mask leak, or for how clinicians should use these data. METHODS: American Thoracic Society (ATS) committee members were invited, based on their expertise in OSA and CPAP monitoring. Their conclusions were based on both empirical evidence identified by a comprehensive literature review and clinical experience. RESULTS: CPAP usage can be reliably determined from CPAP tracking systems, but the residual events (apnea/hypopnea) and leak data are not as easy to interpret as CPAP usage and the definitions of these parameters differ among CPAP manufacturers. Nonetheless, ends of the spectrum (very high or low values for residual events or mask leak) appear to be clinically meaningful. CONCLUSIONS: Providers need to understand how to interpret CPAP adherence tracking data. CPAP tracking systems are able to reliably track CPAP adherence. Nomenclature on the CPAP adherence tracking reports needs to be standardized between manufacturers and AHIFlow should be used to describe residual events. Studies should be performed examining the usefulness of the CPAP tracking systems and how these systems affect OSA outcomes.