A Protocol to Determine Circadian Phase by At-Home Salivary Dim Light Melatonin Onset Assessment.

Internal circadian phase assessment is increasingly acknowledged as a critical clinical tool for the diagnosis, monitoring, and treatment of circadian rhythm sleep-wake disorders and for investigating circadian timing in other medical disorders. The widespread use of in-laboratory circadian phase assessments in routine practice has been limited, most likely because circadian phase assessment is not required by formal diagnostic nosologies, and is not generally covered by insurance. At-home assessment of salivary dim light melatonin onset (DLMO, a validated circadian phase marker) is an increasingly accepted approach to assess circadian phase. This approach may help meet the increased demand for assessments and has the advantages of lower cost and greater patient convenience. We reviewed the literature describing at-home salivary DLMO assessment methods and identified factors deemed to be important to successful implementation. Here, we provide specific protocol recommendations for conducting at-home salivary DLMO assessments to facilitate a standardized approach for clinical and research purposes. Key factors include control of lighting, sampling rate, and timing, and measures of patient compliance. We include findings from implementation of an optimization algorithm to determine the most efficient number and timing of samples in patients with Delayed Sleep-Wake Phase Disorder. We also provide recommendations for assay methods and interpretation. Providing definitive criteria for each factor, along with detailed instructions for protocol implementation, will enable more widespread adoption of at-home circadian phase assessments as a standardized clinical diagnostic, monitoring, and treatment tool.

Factors associated with treatment outcomes after use of auto-titrating CPAP therapy in adults with obstructive sleep apnea.

OBJECTIVES: To determine factors that are associated with OSA therapy outcomes with auto-titrating positive airway pressure (APAP). METHODS: We sequentially grouped patients from a retrospective cohort based on APAP efficacy (sufficiently vs. insufficiently treated; insufficiently treatment defined as residual AHI of ≥ 5), therapy adherence (adherent vs. non-adherent, non-adherence defined as < 70% usage for ≥ 4 h/night), and therapy outcomes (optimal vs. non-optimal and non-optimal outcomes defined as non-adherent and/or insufficiently treated). We subsequently compared each group. RESULTS: The insufficiently treated were older (68.4 ± 12.5 vs. 60.4 ± 13.1 years, p < 0.01) and had lower BMI (31.9 ± 6.3 vs. 37.9 ± 9.1 kg/m2, p < 0.01). They had higher baseline central apnea indices (CAI), longer leaks, higher peak pressures, and were less compliant. The non-adherent were younger (61.1 ± 12.6 vs. 65.5 ± 13.2 years, p = 0.03) and comprised more females (56.1 vs. 43.9%, p = 0.04). The leak duration per usage hour was higher in the non-compliant (median: 1.5; IQR 7.9 vs. median: 0.3; IQR 1.9 min/h; p < 0.01). The non-optimally treated had lower BMI, longer leaks, and less nightly usage. Multivariate analyses showed that leak duration was the common factor associated with treatment effectiveness and optimal therapy outcomes. CONCLUSIONS: Various demographic and clinical factors were associated with treatment efficacy and adherence. However, leak duration was the common factor related to treatment efficacy and overall optimal therapy outcomes.

Inpatient CPAP adherence may predict post-discharge adherence in hospitalized patients screened high risk for OSA.

RATIONALE: Despite increased recognition of sleep disordered breathing in hospitalized patients, studies are lacking on the impact of inpatient adherence with positive airway pressure (PAP) therapy on post-discharge adherence. OBJECTIVES: To assess the predictive value of inpatient adherence to PAP therapy on post-discharge compliance and adherence. METHODS: We reviewed data on individuals as part of a registry of a hospital-based sleep medicine program between August 2019 and December 2020. Consecutive patients identified as high risk for sleep disordered breathing based on our 2-tier screening process and initiated on Auto-PAP (APAP) therapy were included. Their adherence and post-discharge course were recorded. Primary objectives were polysomnography (PSG) compliance, sleep medicine clinic follow-up compliance, and 30-day adherence to PAP therapy if indicated by PSG. RESULTS: In total, 900 individuals were screened during the study period. Of these, 281 were offered inpatient PAP therapy. Patients on bilevel PAP therapy (88 patients) were excluded due to lack of objective compliance recording. Final analysis was performed on 193 patients. Of the 193 patients placed on inpatient APAP, 140 (73%) were adherent to the therapy with average usage of 367 min per day versus 140 min per day in the non-adherent (p < 0.001). There was no significant difference in oxygen desaturation index between the adherent and non-adherent groups (32.4 ± 21.9 events per hour and 34.5 ± 21.9 events per hour consistent; p = 0.5). No demographic and anthropometric characteristics or comorbid conditions were noted. Those who were adherent to PAP therapy in-hospital 47/140 (34%) underwent ambulatory PSG post-discharge compared to 7/53 (13%) of those non-adherent in-hospital (p = 0.002). The adherent group also had significantly higher likelihood for post-discharge clinic follow-up (p = 0.01) and adherence to outpatient PAP therapy (p = 0.01). CONCLUSIONS: Hospitalized patients identified as high risk for sleep disordered breathing have high adherence to PAP therapy during hospitalization and inpatient adherence predicts outpatient follow-up (both PSG testing and sleep clinic) and home PAP adherence.

BASH-GN: a new machine learning-derived questionnaire for screening obstructive sleep apnea.

PURPOSE: This study aimed to develop a machine learning-based questionnaire (BASH-GN) to classify obstructive sleep apnea (OSA) risk by considering risk factor subtypes. METHODS: Participants who met study inclusion criteria were selected from the Sleep Heart Health Study Visit 1 (SHHS 1) database. Other participants from the Wisconsin Sleep Cohort (WSC) served as an independent test dataset. Participants with an apnea hypopnea index (AHI) ≥ 15/h were considered as high risk for OSA. Potential risk factors were ranked using mutual information between each factor and the AHI, and only the top 50% were selected. We classified the subjects into 2 different groups, low and high phenotype groups, according to their risk scores. We then developed the BASH-GN, a machine learning-based questionnaire that consists of two logistic regression classifiers for the 2 different subtypes of OSA risk prediction. RESULTS: We evaluated the BASH-GN on the SHHS 1 test set (n = 1237) and WSC set (n = 1120) and compared its performance with four commonly used OSA screening questionnaires, the Four-Variable, Epworth Sleepiness Scale, Berlin, and STOP-BANG. The model outperformed these questionnaires on both test sets regarding the area under the receiver operating characteristic (AUROC) and the area under the precision-recall curve (AUPRC). The model achieved AUROC (SHHS 1: 0.78, WSC: 0.76) and AUPRC (SHHS 1: 0.72, WSC: 0.74), respectively. The questionnaire is available at https://c2ship.org/bash-gn . CONCLUSION: Considering OSA subtypes when evaluating OSA risk may improve the accuracy of OSA screening.

How to interpret a negative high-resolution pulse oximetry in hospitalized patients screened for obstructive sleep apnea: an exploratory analysis.

INTRODUCTION: Obstructive sleep apnea (OSA) is a highly prevalent disorder that often is unrecognized. Recently, a novel protocol for screening hospitalized patients for OSA resulted in early initiation of positive airway pressure (PAP) therapy and early post-discharge follow-up. The protocol utilizes a combination of high-resolution pulse oximetry (HRPO) and home sleep apnea tests (HSATs); the former has been well-validated in previous studies against HSAT and polysomnography. While a definitive treatment plan can be generated for patients with a positive HRPO for OSA, it is less clear how best to manage patients with a negative HRPO. MATERIALS AND METHODS: A retrospective analysis of a registry of patients screened for OSA was conducted. Consecutive patients with HRPO-derived ODI (oxygen desaturation index) < 5/h who underwent same-night HRPO and HSAT were identified. The demographic and clinical characteristics of patients with ODI < 5/h and AHI (apnea hypopnea index) < 5/h were compared with patients with ODI < 5/h and AHI ≥ 5/h. RESULTS: The analysis revealed 190 patients with ODI < 5/h. Only 23 (12%) of these patients had AHI ≥ 5/h. When compared with patients who had ODI < 5/h and AHI < 5/h, there was no difference in most testing and patient characteristics. However, antiplatelet use and total time in minutes with saturation < 88% greater than 100 min were associated with a higher likelihood of discordant ODI and AHI. CONCLUSION: HRPO-derived ODI has a low rate of false negativity. Clinicians should be aware of the possibility of a false negative ODI for patients with antiplatelet use and time with saturation < 88% greater than 100 min and antiplatelet therapy.

Examining Changes in Sleep Duration Associated with the Onset of the COVID-19 Pandemic: Who is Sleeping and Who is Not?

The COVID-19 pandemic has resulted in social isolation and reports of insomnia. However, reports of changes in sleep duration and associated factors are few. To determine the impact of COVID-19 on changes in sleep behavior, data were analyzed from an online survey of adults recruited via social media that included questions asking whether the respondent slept less or more after the onset of the pandemic as well as self-reported sociodemographic and occupational information; beliefs about COVID-19; and responses pertaining to loneliness, anxiety, and depression. There were 5,175 respondents; 53.9% had a change in sleep duration.17.1% slept less and 36.7% slept more. Sleeping more was related to greater education, being single/divorced/separated, unemployed or a student. Being retired, divorced/separated or a homemaker, and living in the Mountain or Central time zones were associated with less sleep. Beliefs that COVID-19 would result in personal adverse consequences was associated with both more and less sleep. However, the strongest associations for both more and less sleep were seen with depression, anxiety, and loneliness. In summary, changes in sleep duration since the start of the COVID-19 pandemic were highly prevalent among social media users and were associated with several sociodemographic factors and beliefs that COVID-19 would have adverse personal impacts. However, the strongest associations occurred with worse mental health suggesting that improvements may occur with better sleep.Supplemental data for this article is available online at https://doi.org/10.1080/08964289.2021.2002800 .

Exploring Sleep in Caregivers of Children with Autism Spectrum Disorder (ASD) and the Relationship to Health-Related Quality of Life (HRQoL) and Family Quality of Life (FQoL).

Background and Objectives: To investigate (1) the prevalence of sleep disorder symptoms in caregivers of children with autism spectrum disorder (ASD) and (2) the relationships between caregiver sleep problems and their health-related quality of life and family quality of life. Materials and Methods: Descriptive cross-sectional study of caregivers (N = 62) of children aged 6 to 11 years old diagnosed with ASD and receiving care at a regional autism research and resource center. Results: Participants completed the Sleep Habits Questionnaire (SHQ), the Medical Outcomes Study (MOS) SF-12, and the Beach Center Family Quality of Life Scale (FQoL). Caregivers with longer sleep duration reported better mental health and better family quality of life. Caregivers who reported insomnia symptoms, non-restorative sleep, and insufficient sleep were more likely to report poorer mental health than caregivers who did not report these sleep disorder symptoms. Caregivers with obstructive sleep apnea and restless legs syndrome experienced worse physical quality of life. Conclusions: The physical and mental health of the primary caregiver is essential to the support of the child with ASD and to the functioning of the family. The study findings point to the importance of future research and interventions to enhance sleep health in order to improve quality of life for caregivers of children with ASD.

Sleepiness in obstructive sleep apnea using hypopneas defined by a 3% oxygen desaturation or arousal but not by 4% or greater oxygen desaturation.

STUDY OBJECTIVES: This analysis determined the association between obstructive sleep apnea (OSA) with hypopneas defined by a 3% O2 desaturation or arousal (3%A), but not by a hypopnea criterion of ≥ 4% (4%), and subjective sleepiness. METHODS: Data were analyzed from Sleep Heart Health Study participants who had polysomnography (N = 6307) regarding OSA and subjective sleepiness scores (Epworth Sleepiness Scale, ESS). The apnea hypopnea index (AHI) was classified based on 3% only, 3%A only, and 4% definitions of hypopneas. RESULTS: Of the 3326 participants without 4% OSA, 67.6% (n = 2247) had 3%A only OSA. The ESS score was higher in 3%A only OSA than in those without OSA (7.44 ± 4.2 vs 7.07 ± 4.3, P = 0.02). Of those without 4% OSA, 40.2% (n = 1336) had 3% only OSA. The ESS score was higher in those with 3% only OSA than those with no OSA (7.72 ± 4.3 vs 7.05 ± 4.2, P < 0.001). A linear regression model demonstrated a trend towards significance for the 3%A only AHI as an independent predictor of ESS when controlled for age, BMI, and sex (P = 0.051). The association of 3% only AHI with the ESS was stronger (P = 0.003). However, 23.3% of the participants with hypersomnia would not qualify as having OSA if arousals were excluded from the definition of OSA. CONCLUSION: The current study found that the presence and severity of OSA is associated with higher ESS scores in persons with 3%A only OSA. Hence, the use of the 4% hypopnea definition will result in the failure to identify and treat a significant number of individuals with OSA who have subjective sleepiness.

Addressing rural health disparity with a novel hospital sleep apnea screening: Precision of a high-resolution pulse oximeter in screening for sleep-disordered breathing.

PURPOSE: High-resolution pulse oximetry (HRPO) may offer a low-cost and simple screening option for sleep-disordered breathing (SDB) that could be vitally important in rural areas with limited healthcare resources and specialty care. Our team hypothesized that application of this technology to a broad cohort of rural dwelling hospitalized individuals would demonstrate congruence similar to previous urban studies comparing HRPO to portable sleep monitors. METHODS: This retrospective study was conducted at West Virginia University Hospital and compared indices obtained from HRPO with those obtained from a type III portable sleep monitor (PM) on the same night. RESULTS: A total of 365 individuals underwent evaluation. The mean oxygen desaturation index (18.8 ± 19.3 events/h) from the HRPO was slightly higher than the mean respiratory event index (16.0 ± 18.1 events/h, p ≤ 0.001) from the PM. ROC curves were developed for thresholds of apnea severity predicted by the screening program. The AUC values for all three thresholds exceeded 0.92 and for a respiratory event index (REI) of ≥ 30 was 0.965. Indices from the PM and HRPO demonstrated agreement in those individuals with screening suggestive of moderate to severe disease. CONCLUSION: This study demonstrates that use of HRPO in screening for SDB in hospitalized patients from rural communities is as accurate as PM and may serve as a simple cost-effective tool to address sleep health disparities in these regions with significant health inequity. Our data extend previous findings by applying HRPO to a larger hospitalized cohort with highly prevalent cardiopulmonary disease.

Sleep difficulties, incident dementia and all-cause mortality among older adults across 8 years: Findings from the National Health and Aging Trends Study.

Sleep difficulties have been implicated in the development and progression of dementia and in all-cause mortality. This study examines the relationship between sleep difficulties, incident dementia and all-cause mortality over 8 years of follow-up among a nationally representative sample of older (≥65 years) adults in the United States. We used data collected from the National Health and Aging Trends Study (NHATS) from 2011 to 2018, a prospective cohort study of Medicare beneficiaries. At baseline, the NHATS sample comprised 6,376 older adults who were representative of 32 million older adults. Respondents reported routine difficulty initiating sleep or difficulty falling back asleep "most nights" or "every night" in each study year. In each year, dementia was determined by either self-reported diagnosis or performance on immediate and delayed recall word and clock drawing tests, whereas all-cause mortality was determined by proxy. We conducted Cox proportional hazards modelling, adjusting for age, sex, marital status and chronic conditions. In models predicting all-cause mortality, we also controlled for dementia. Among respondents at baseline, 19% were 65-75 years of age, 71% identified as non-Hispanic white and 59% were female. Difficulty initiating sleep (hazard ratio [HR], 1.49; 95% confidence interval [CI],1.25-1.77), difficulty falling back asleep (HR, = 1.39; 95% CI,1.14-1.70) and concurrent sleep difficulties (HR, 1.58; 95% CI, 1.25-1.99) were associated with greater risk of dementia. Difficulty initiating sleep (HR, 1.44; 95% CI,1.20-1.72), difficulty falling back asleep (HR, 1.56; 95% CI,1.29-1.89), and concurrent sleep difficulties (HR, 1.80; 95% CI, 1.44-2.24) were associated with greater risk of all-cause mortality. Our findings demonstrate that reported difficulties are prospectively associated with an increased risk of dementia and all-cause mortality among older people.

Predictive ability of the International Classification of Sleep Disorders-3 in identifying risk of obstructive sleep apnea among recently unemployed adults.

BACKGROUND: The International Classification of Sleep Disorders (ICSD)-3 was developed to aid in the identification of these disorders. The core criterion A (ICSD-3A) to identify obstructive sleep apnea (OSA) requires the presentence of specific signs and symptoms. This study explores the predictive ability of the ICSD-3A for OSA as compared with objective measures of respiratory event index (REI). PARTICIPANTS: A total of 291 participants who completed a home sleep apnea test (HSAT) during the screening evaluation of the Assessing Daily Activity Patterns through occupational Transitions (ADAPT) study were included. METHODS: Participants were classified as having mild OSA (REI ≥ 5 and < 15), moderate (≥ 15 to < 30), or severe OSA (> 30). Predictive parameters identifying participants as having OSA by the ICSD-3A criteria were assessed using REI classifications as the reference standard and further compared with a subsample using the STOP-Bang questionnaire. RESULTS: The ICSD-3A had a sensitivity of 19.2% for identifying participants as having moderate to severe OSA and specificity of 84.4%. The ICSD-3A had a receiver operating characteristics (ROC) = 0.53. On the subsample of participants, the STOP-Bang questionnaire's ROC is 0.61. Results were similar when examining the classification of participants with mild compared with no OSA. CONCLUSION: In this population, the ability of the ICSD-3A in detecting moderate to severe OSA as well as mild OSA was low. The ROC for the ICSD-3 did not differ significantly from the STOP-Bang questionnaire's ROC in this research population.

Correction: Estimated Sleep Duration Before and During the COVID-19 Pandemic in Major Metropolitan Areas on Different Continents: Observational Study of Smartphone App Data.

[This corrects the article DOI: 10.2196/20546.].

Estimated Sleep Duration Before and During the COVID-19 Pandemic in Major Metropolitan Areas on Different Continents: Observational Study of Smartphone App Data.

BACKGROUND: Amid the COVID-19 pandemic, public health policies to curb the spread of SARS-CoV-2 and its associated disease, COVID-19, have resulted in significant alterations to daily routines (eg, work-from-home policies) that may have enabled longer sleep duration among the general population. OBJECTIVE: We aimed to examine changes in estimated sleep duration in 5 major metropolitan areas before and after the start of the COVID-19 pandemic. METHODS: We conducted a prospective observational study using estimated sleep duration data obtained from a smartphone app. The data were obtained from regular users of the smartphone app before and after the World Health Organization declared COVID-19 a pandemic in March 2020. We compared within-subject estimated sleep duration before and during the COVID-19 pandemic using generalized linear mixed models. RESULTS: Among the 2,871,037 observations, 957,022 (33.3%) were from users in London; 549,151 (19.1%) were from users in Los Angeles; 846,527 (29.5%) were from users in New York City; 251,113 (8.7%) were from users in Seoul; and 267,224 (9.3%) were from users in Stockholm. The average age of the users in the sample was 35 years (SE 11 years). Prior to the COVID-19 pandemic, people residing in Seoul had the shortest estimated sleep duration (mean 6 hours 28 minutes, SE 11.6 minutes) and those residing in Stockholm had the longest estimated sleep duration (mean 7 hours 34 minutes, SE 9.9 minutes). The onset of the COVID-19 pandemic was associated with a 13.7 minute increase in estimated sleep duration when comparing March 2019 and March 2020 (95% CI 13.1-14.3, P<.001) and an increase of 22.3 minutes when comparing April 2019 and April 2020 (95% CI 21.5-23.1, P<.001). CONCLUSIONS: The average estimated sleep duration increased sharply in the months after the onset of the COVID-19 pandemic. This finding suggests that the implementation of COVID-19 mitigation strategies has provided people worldwide with increased opportunities to sleep, which may enhance the response of the immune system to viral pathogens.

Effects of continuous positive airway pressure on blood pressure in obstructive sleep apnea patients: The Apnea Positive Pressure Long-term Efficacy Study (APPLES).

Obstructive sleep apnea is associated with hypertension, and short-term studies have demonstrated a modest reduction in blood pressure with continuous positive airway pressure therapy. We evaluated the effects of continuous positive airway pressure versus sham continuous positive airway pressure on blood pressure in 1,101 participants with obstructive sleep apnea from the Apnea Positive Pressure Long-term Efficacy Study, a randomized, sham-controlled double-blinded study designed to assess the impact of continuous positive airway pressure on neurocognition. Participants with apnea-hypopnea index ≥ 10 were randomly assigned to continuous positive airway pressure or sham continuous positive airway pressure. Blood pressures measured in the morning and evening at baseline, 2 months and 6 months were analysed post hoc using a mixed-model repeated-measures analysis of variance. The largest magnitude reduction was approximately 2.4 mmHg in morning systolic pressure that occurred at 2 months in the continuous positive airway pressure arm as compared with an approximate 0.5 mmHg reduction in the sham group (continuous positive airway pressure effect -1.9 mmHg, p = .008). At 6 months, the difference between groups was diminished and no longer statistically significant (continuous positive airway pressure effect -0.9 mmHg, p = .12). Sensitivity analysis with use of multiple imputation approaches to account for missing data did not change the results. Treatment with continuous positive airway pressure for obstructive sleep apnea reduces morning but not evening blood pressure in a population with well-controlled blood pressure. The effect was greater after 2 than after 6 months of treatment.

Sleep-disordered breathing in hospitalized patients with congestive heart failure: a concise review and proposed algorithm.

Congestive heart failure (CHF) is the most common cause of hospital admission in the USA costing the taxpayers billions of dollars. Sleep-disordered breathing (SDB) is a common co-morbid condition associated with CHF with prevalence estimated to be 60-70%. Despite substantial evidence supporting the negative impact of SDB on CHF, the condition is underrecognized and undertreated. Patients admitted to the hospital with CHF and SDB are prime candidates for intervention with positive airway pressure (PAP) therapy as they form a "captive audience," and timely intervention and education may mitigate sub-optimal outcomes. In conclusion, this review explores emerging data on the cost effectiveness and outcome of early intervention with PAP in hospitalized CHF patients.

Positional therapy in the management of positional obstructive sleep apnea-a review of the current literature.

More than 50% of obstructive sleep apnea (OSA) patients have worsening of their OSA in the supine position (positional obstructive sleep apnea [POSA], commonly defined as supine to non-supine apnea hypopnea index (AHI) ratio of ≥ 2). Positional therapy (PT) aims to prevent patients from sleeping in the supine position. One of the major limiting factors to the routine use of PT in clinical practice is the lack of validated tools to measure compliance objectively. Furthermore, there are no universal guidelines to determine if PT will be effective as standalone or as adjunctive therapy. This paper assesses recent literature on PT demonstrating its effectiveness in management of POSA. It also outlines the proposed subclassification systems for POSA. Electronic literature review was done on EMBASE. Since the last review of PT by Ravesloot et al. (2012), ten studies were identified which demonstrate effectiveness of PT in POSA. We found three publications proposing different subclassification systems for POSA. There were three studies validating different compliance monitoring tools for PT. One study showed the cost benefits of incorporating PT into OSA management. Positional therapy is an effective treatment for POSA and progress has been made in development of tools for measuring compliance. Creating a subclassification of POSA may help develop targeted therapy for patients and determine its use as standalone or adjunct therapy. The integration of PT into POSA management may be cost-effective when compared to the use of CPAP alone.

CPAP versus oxygen in obstructive sleep apnea.

BACKGROUND: Obstructive sleep apnea is associated with hypertension, inflammation, and increased cardiovascular risk. Continuous positive airway pressure (CPAP) reduces blood pressure, but adherence is often suboptimal, and the benefit beyond management of conventional risk factors is uncertain. Since intermittent hypoxemia may underlie cardiovascular sequelae of sleep apnea, we evaluated the effects of nocturnal supplemental oxygen and CPAP on markers of cardiovascular risk. METHODS: We conducted a randomized, controlled trial in which patients with cardiovascular disease or multiple cardiovascular risk factors were recruited from cardiology practices. Patients were screened for obstructive sleep apnea with the use of the Berlin questionnaire, and home sleep testing was used to establish the diagnosis. Participants with an apnea-hypopnea index of 15 to 50 events per hour were randomly assigned to receive education on sleep hygiene and healthy lifestyle alone (the control group) or, in addition to education, either CPAP or nocturnal supplemental oxygen. Cardiovascular risk was assessed at baseline and after 12 weeks of the study treatment. The primary outcome was 24-hour mean arterial pressure. RESULTS: Of 318 patients who underwent randomization, 281 (88%) could be evaluated for ambulatory blood pressure at both baseline and follow-up. On average, the 24-hour mean arterial pressure at 12 weeks was lower in the group receiving CPAP than in the control group (-2.4 mm Hg; 95% confidence interval [CI], -4.7 to -0.1; P=0.04) or the group receiving supplemental oxygen (-2.8 mm Hg; 95% CI, -5.1 to -0.5; P=0.02). There was no significant difference in the 24-hour mean arterial pressure between the control group and the group receiving oxygen. A sensitivity analysis performed with the use of multiple imputation approaches to assess the effect of missing data did not change the results of the primary analysis. CONCLUSIONS: In patients with cardiovascular disease or multiple cardiovascular risk factors, the treatment of obstructive sleep apnea with CPAP, but not nocturnal supplemental oxygen, resulted in a significant reduction in blood pressure. (Funded by the National Heart, Lung, and Blood Institute and others; HeartBEAT ClinicalTrials.gov number, NCT01086800 .).

Predictors of sleepiness in obstructive sleep apnoea at baseline and after 6†months of continuous positive airway pressure therapy.

We evaluated factors associated with subjective and objective sleepiness at baseline and after 6 months of continuous positive airway pressure (CPAP) therapy in patients with obstructive sleep apnoea (OSA).We analysed data from the Apnoea Positive Pressure Long-term Efficacy Study (APPLES), a prospective 6-month multicentre randomised controlled trial with 1105 subjects with OSA, 558 of who were randomised to active CPAP. Epworth sleepiness scale (ESS) scores and the mean sleep latency (MSL) on the maintenance of wakefulness test at baseline and after 6 months of CPAP therapy were recorded.Excessive sleepiness (ESS score >10) was present in 543 (49.1%) participants. Younger age, presence of depression and higher apnoea-hypopnoea index were all associated with higher ESS scores and lower MSL. Randomisation to the CPAP group was associated with lower odds of sleepiness at 6 months. The prevalence of sleepiness was significantly lower in those using CPAP >4 h·night-1versus using CPAP ≤4 h·night-1 Among those with good CPAP adherence, those with ESS >10 at baseline had significantly higher odds (OR 8.2, p<0.001) of persistent subjective sleepiness.Lower average nightly CPAP use and presence of sleepiness at baseline were independently associated with excessive subjective and objective sleepiness after 6 months of CPAP therapy.

Impact of continuous positive airway pressure and oxygen on health status in patients with coronary heart disease, cardiovascular risk factors, and obstructive sleep apnea: A Heart Biomarker Evaluation in Apnea Treatment (HEARTBEAT) analysis.

INTRODUCTION: Obstructive sleep apnea (OSA) is associated with impaired health-related quality of life (HRQL). Treatment with continuous positive airway pressure (CPAP) has variable impacts on HRQL, and this may be influenced by patient's tolerance of therapy. The objective is to determine the impact of nocturnal supplemental oxygen (NSO) and CPAP on HRQL compared with healthy lifestyle education (HLSE) in individuals with OSA. METHODS: Patients with coronary heart disease (CHD) or at least 3 major CHD risk factors with apnea-hypopnea index of 15 to 50 events/h were randomized to CPAP, NSO, or HLSE. Health-related quality of life was assessed using the Short-Form 36, and depression was assessed with Patient Health Questionnaire-9 at baseline and 12 weeks. The treatment effect on HRQL change scores through 12 weeks was assessed using multivariable models adjusting for study site, presence of CHD at baseline, race, and baseline HRQL. RESULTS: A total of 318 patients were randomized to 1 of 3 treatment arms with 1:1:1 ratio and 94% completed baseline and follow-up HRQL instruments. Mean Short-Form 36 scores were similar at baseline in all 3 groups ranging from 41.8±12 to 51.6±12 in various domains. In multivariable models, the CPAP group noted a significantly greater improvement than NSO in mental health (+2.33, 95% CI 0.34-4.31, P=.02) and mental composite score (+2.40, 95% CI 0.40-4.41, P=.02). Conversely, the CPAP group noted less improvement than NSO in physical function (-2.68, 95% CI -4.66 to -0.70, P=.008) and physical composite score (-2.17, 95% CI -3.82 to -0.51, P=.01). Compared with HLSE, vitality and Patient Health Questionnaire-9 improved with CPAP but not with NSO. Significant interactions were noted between treatment effects with larger differences in black and sleepy patients. CONCLUSION: These data support the use of CPAP for improving vitality, sleepiness, mental health, social functioning, and depressive symptoms in patients with OSA and established CHD or risk factors. Nocturnal supplemental oxygen may have beneficial effects on perceived physical functioning.

Influence of Lung Function and Sleep-disordered Breathing on All-Cause Mortality. A Community-based Study.

RATIONALE: Whether sleep-disordered breathing (SDB) severity and diminished lung function act synergistically to heighten the risk of adverse health outcomes remains a topic of significant debate. OBJECTIVES: The current study sought to determine whether the association between lower lung function and mortality would be stronger in those with increasing severity of SDB in a community-based cohort of middle-aged and older adults. METHODS: Full montage home sleep testing and spirometry data were analyzed on 6,173 participants of the Sleep Heart Health Study. Proportional hazards models were used to calculate risk for all-cause mortality, with FEV1 and apnea-hypopnea index (AHI) as the primary exposure indicators along with several potential confounders. MEASUREMENTS AND MAIN RESULTS: All-cause mortality rate was 26.9 per 1,000 person-years in those with SDB (AHI ≥5 events/h) and 18.2 per 1,000 person-years in those without (AHI <5 events/h). For every 200-ml decrease in FEV1, all-cause mortality increased by 11.0% in those without SDB (hazard ratio, 1.11; 95% confidence interval, 1.08-1.13). In contrast, for every 200-ml decrease in FEV1, all-cause mortality increased by only 6.0% in participants with SDB (hazard ratio, 1.06; 95% confidence interval, 1.04-1.09). Additionally, the incremental influence of lung function on all-cause mortality was less with increasing severity of SDB (P value for interaction between AHI and FEV1, 0.004). CONCLUSIONS: Lung function was associated with risk for all-cause mortality. The incremental contribution of lung function to mortality diminishes with increasing severity of SDB.