Beyond CPAP: modifying upper airway output for the treatment of OSA.

Obstructive Sleep Apnea (OSA) is exceedingly common but often under-treated. Continuous positive airway pressure (CPAP) has long been considered the gold standard of OSA therapy. Limitations to CPAP therapy include adherence and availability. The 2021 global CPAP shortage highlighted the need to tailor patient treatments beyond CPAP alone. Common CPAP alternative approaches include positional therapy, mandibular advancement devices, and upper airway surgery. Upper airway training consists of a variety of therapies, including exercise regimens, external neuromuscular electrical stimulation, and woodwind instruments. More invasive approaches include hypoglossal nerve stimulation devices. This review will focus on the approaches for modifying upper airway muscle behavior as a therapeutic modality in OSA.

Effect of Two Interventional Strategies on Improving Continuous Positive Airway Pressure Adherence in Existing COPD and Obstructive Sleep Apnea Patients: The O2VERLAP Study.

Background: Obstructive sleep apnea (OSA) is a sleep disorder prevalent in >10% of individuals diagnosed with chronic obstructive pulmonary disease (COPD). Continuous positive airway pressure (CPAP) is the first-line therapy for OSA, but many do not use it enough during sleep to effectively manage OSA. The O2VERLAP study compared proactive care (PC)-structured web-based peer-coaching education and support intervention versus reactive care (RC)-education and support based on limited scheduled interactions and patient-initiated contacts. Methods: Participants were primarily recruited from patient communities (COPD, OSA, and the National Patient-Centered Outcomes Research Network [PCORnet]) through electronic methods. Inclusion criteria: ≥40 years old, diagnosis of both COPD and OSA, and currently using CPAP. Participants were then randomly assigned to either the PC or RC group, with outcomes assessed at baseline and 6 and 12 weeks. The primary study outcome was CPAP adherence (hours of use/night) and secondary outcomes were daytime functioning, sleep quality, and daytime sleepiness. Changes in outcomes over time were examined using random effects models. Results: The study enrolled 332 participants of which 294 were randomized. While groups differed significantly in CPAP adherence at baseline (PC: 6.1±3.1, RC: 7.3±2.4 hours/night; P<0.001), there were no significant differences in change of primary and secondary outcomes at either 6 or 12 weeks. Conclusion: In this group of patients with both COPD and OSA on CPAP therapy, no difference was found between the provision of PC and RC. The study did find unexpectedly high baseline CPAP adherence levels, which suggests that any improvement from the intervention would have been very small and difficult to detect.

Outcomes Important to Patients Diagnosed with Both COPD and Sleep Apnea: Findings from the O2VERLAP Study Focus Groups.

INTRODUCTION: Few studies have asked chronic obstructive pulmonary disease (COPD) -obstructive sleep apnea (OSA) overlap syndrome patients what outcomes of continuous positive airway pressure (CPAP) therapy are important to them, while also considering their self-reported CPAP adherence barriers and facilitators. This study conducted a series of focus groups to learn about those issues with the goal of applying these findings to the design of a larger Patient-Centered Outcomes Research Institute-funded scientific study, the O2VERLAP Study. METHODS: People previously diagnosed with both COPD and OSA, who were current or recent past users of the standard therapy for each condition (i.e., supplemental oxygen and CPAP, respectively), were included. Three qualitative focus groups were run using different communication modalities: (1) teleconference (audio only), (2) in-person, and (3) web-based. RESULTS: The focus groups included a total of 17 participants. The telephone and online focus groups resulted in more relevant and content-rich transcripts, while the in-person focus groups had far fewer excerpts able to be coded. Participants were most concerned about mask fit and comfort. Other key factors affecting CPAP use included nasal dryness and issues concerning insurance. The most important outcome to patients was daytime functioning. DISCUSSION: This work found that telephone and web-based qualitative focus groups resulted in greater topical discussions than in-person focus groups, likely due to the customary socializing that occurs in-person. The study identified: (1) CPAP use barriers and facilitators that helped guide intervention development for the larger study and, (2) daytime functioning as the most important outcome for patients.

Indirect treatment comparison of solriamfetol, modafinil, and armodafinil for excessive daytime sleepiness in obstructive sleep apnea.

STUDY OBJECTIVES: Excessive daytime sleepiness associated with obstructive sleep apnea affects 9%-22% of continuous positive airway pressure-treated patients. An indirect treatment comparison meta-analysis was performed to compare efficacy and safety of medications (solriamfetol, modafinil, and armodafinil) approved to treat excessive daytime sleepiness associated with obstructive sleep apnea. METHODS: Efficacy and safety measures assessed in this indirect treatment comparison included Epworth Sleepiness Scale (ESS), 20-minute Maintenance of Wakefulness Test (MWT20), Clinical Global Impression of Change (CGI-C), Functional Outcomes of Sleep Questionnaire (FOSQ), and incidence of treatment-emergent adverse events (any, serious, or leading to discontinuation). RESULTS: A systematic literature review identified 6 parallel-arm, placebo-controlled randomized controlled trials that randomized 1,714 total participants to placebo, solriamfetol, modafinil, or armodafinil. In this indirect treatment comparison, all comparators were associated with greater improvements than placebo on the ESS, MWT20, and CGI-C after 4, 8, and 12 weeks of treatment. Relative to comparators and placebo at 12 weeks, solriamfetol at 150 mg or 300 mg had the highest probabilities of improvement in the ESS, MWT20, and CGI-C. Modafinil (200 or 400 mg) and solriamfetol (150 or 300 mg) were associated with greater improvement on the FOSQ than placebo at 12 weeks. Less than 2% of patients using placebo or comparators experienced serious or discontinuation-related treatment-emergent adverse events. CONCLUSIONS: The results of this indirect treatment comparison show 12 weeks of treatment with solriamfetol, modafinil, and armodafinil resulted in varying levels of improvement on the ESS, MWT20, and CGI-C and similar safety risks in participants with excessive daytime sleepiness associated with obstructive sleep apnea. CITATION: Ronnebaum S, Bron M, Patel D, et al. Indirect treatment comparison of solriamfetol, modafinil, and armodafinil for excessive daytime sleepiness in obstructive sleep apnea. J Clin Sleep Med. 2021;17(12):2543-2555.

Randomized controlled trial of an integrated approach to treating insomnia and improving the use of positive airway pressure therapy in veterans with comorbid insomnia disorder and obstructive sleep apnea.

STUDY OBJECTIVES: Cognitive behavioral therapy for insomnia (CBTI) for comorbid insomnia and obstructive sleep apnea (OSA) has had mixed results. We integrated CBTI with a positive airway pressure (PAP) adherence program and tested effects on sleep and PAP use. METHODS: 125 veterans (mean age 63.2, 96% men, 39% non-Hispanic white, 26% black/African American, 18% Hispanic/Latino) with comorbid insomnia and newly-diagnosed OSA (apnea-hypopnea index ≥ 15) were randomized to 5-weekly sessions integrating CBTI with a PAP adherence program provided by a "sleep coach" (with behavioral sleep medicine supervision), or 5-weekly sleep education control sessions. Participants and assessment staff were blinded to group assignment. Outcomes (baseline, 3 and 6 months) included Pittsburgh Sleep Quality Index (PSQI), 7-day sleep diary (sleep onset latency [SOL-D], wake after sleep onset [WASO-D], sleep efficiency [SE-D]), 7-day actigraphy (SE-A), and objective PAP use (hours/night and nights ≥ 4 h). Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) were also collected. RESULTS: Compared to controls, intervention participants showed greater improvement (baseline to 3 and 6 months, respectively) in PSQI (-3.2 and -1.7), SOL-D (-16.2 and -15.5 minutes), SE-D (10.5% and 8.5%), SE-A (4.4% and 2.6%) and more 90-day PAP use (1.3 and 0.9 more hours/night, 17.4 and 11.3 more nights PAP ≥ 4 h). 90-day PAP use at 3 months was 3.2 and 1.9 h/night in intervention versus controls. Intervention participants also had greater improvements in ISI, ESS, and FOSQ-10 (all p < 0.05). CONCLUSIONS: An intervention integrating CBTI with a PAP adherence program delivered by a supervised sleep coach improved sleep and PAP use in adults with comorbid insomnia and OSA. TRIAL REGISTRATION: ClinicalTrials.govStudy name: Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older VeteransURL: https://clinicaltrials.gov/ct2/results?cond=&term=NCT02027558&cntry=&state=&city=&dist=Registration: NCT02027558.

Barriers and facilitators to the implementation of a novel web-based sleep apnea management platform.

STUDY OBJECTIVE: Obstructive sleep apnea (OSA) is a highly prevalent yet underdiagnosed disorder affecting US military Veterans. The Remote Veterans Apnea Management Platform (REVAMP) is a web-based OSA management program created to improve access to care. REVAMP was launched within the Veterans Health Administration (VHA) in July 2017, with variable patient recruitment rates (from 0 to 573 patients per site) at the first 10 Veterans Affairs (VA) medical centers (Wave-1 sites). This study aimed to examine the contextual circumstances surrounding the implementation of REVAMP from the provider perspective to inform strategies to increase its uptake at future rollout sites. METHODS: A purposive sample of REVAMP site leaders from the Wave-1 sites was recruited with additional staff members being solicited as well. Semi-structured interviews were conducted. Two independent coders reviewed individual transcripts using content analysis to identify emerging themes. RESULTS: Fifteen individuals from Wave-1 sites were interviewed. Implementation of REVAMP was facilitated by the presence of leadership support, staff, and time dedicated to REVAMP, and perceived usefulness of REVAMP by staff as well as positive feedback from the Veterans using REVAMP. The difficulty of supporting Veteran creation of login credentials to the program and integrating REVAMP into the existing workflow were major barriers to its implementation. CONCLUSION: Improving leadership engagement, simplifying the enrollment process, and enhancing the medical staff experience through shared best practice alerts were identified as actions needed to improve the penetration of REVAMP at future rollout sites.

Real-world longitudinal data collected from the SleepHealth mobile app study.

Conducting biomedical research using smartphones is a novel approach to studying health and disease that is only beginning to be meaningfully explored. Gathering large-scale, real-world data to track disease manifestation and long-term trajectory in this manner is quite practical and largely untapped. Researchers can assess large study cohorts using surveys and sensor-based activities that can be interspersed with participants' daily routines. In addition, this approach offers a medium for researchers to collect contextual and environmental data via device-based sensors, data aggregator frameworks, and connected wearable devices. The main aim of the SleepHealth Mobile App Study (SHMAS) was to gain a better understanding of the relationship between sleep habits and daytime functioning utilizing a novel digital health approach. Secondary goals included assessing the feasibility of a fully-remote approach to obtaining clinical characteristics of participants, evaluating data validity, and examining user retention patterns and data-sharing preferences. Here, we provide a description of data collected from 7,250 participants living in the United States who chose to share their data broadly with the study team and qualified researchers worldwide.

Prevalence and management of sleep disorders in the Veterans Health Administration.

The prevalence of diagnosed sleep disorders among Veterans treated at Veterans Affairs (VA) medical facilities increased significantly during fiscal years (FY) 2012 through 2018. Specifically, the prevalence of sleep-related breathing disorders (SRBD) increased from 5.5% in FY2012 to 22.2% in FY2018, and the prevalence of insomnia diagnoses increased from 7.4% in FY2012 to 11.8% in FY2018. Consequently, Veterans' demand for sleep medicine services also increased significantly between FY2012-2018, with steady increases in the annual number of VA sleep clinic appointments during this period (<250,000 in FY 2012; >720,000 in FY2018). Common co-morbid conditions among Veterans diagnosed with sleep disorders include obesity, diabetes, congestive heart failure, depression, post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI). To address this healthcare crisis, the Veterans Health Administration (VHA) developed and/or implemented numerous innovations to improve the quality and accessibility of sleep care services for Veterans. These innovations include a TeleSleep Enterprise-Wide Initiative to improve rural Veterans' access to sleep care; telehealth applications such as the Remote Veteran Apnea Management Platform (REVAMP), Clinical Video Telehealth, and CBT-i Coach; increased use of home sleep apnea testing (HSAT); and programs for Veterans who experience sleep disorders associated with obesity, PTSD, TBI and other conditions.

The economic and societal burden of excessive daytime sleepiness in patients with obstructive sleep apnea.

Excessive daytime sleepiness (EDS) is common in patients with obstructive sleep apnea (OSA) and continues to persist in many patients despite adequate OSA treatment. EDS in OSA is associated with decreased quality of life (QOL) as well as increased societal burden, which may impact health care utilization and costs. However, economic burden is often not the primary focus in the treatment of EDS in OSA. This targeted literature review aimed to examine the published literature on the economic burden of EDS in OSA. This review identified available literature using a targeted PubMed search strategy using search terms related to EDS in OSA in adults. Results demonstrate that there are few studies that detailed the direct costs associated with EDS in OSA, though several studies indicated an association between EDS in OSA and indirect economic burdens, including motor vehicle accidents (MVAs), near misses, work productivity, mood, and QOL. Data from the literature confirmed that persistent EDS in OSA following continuous positive airway pressure persists in 12%-65% of patients. Future studies should further describe the direct costs of EDS in OSA, quantify the cost associated with MVAs and lost work productivity, and detail QOL and social impacts of the condition.

Indicators of retention in remote digital health studies: a cross-study evaluation of 100,000 participants.

Digital technologies such as smartphones are transforming the way scientists conduct biomedical research. Several remotely conducted studies have recruited thousands of participants over a span of a few months allowing researchers to collect real-world data at scale and at a fraction of the cost of traditional research. Unfortunately, remote studies have been hampered by substantial participant attrition, calling into question the representativeness of the collected data including generalizability of outcomes. We report the findings regarding recruitment and retention from eight remote digital health studies conducted between 2014-2019 that provided individual-level study-app usage data from more than 100,000 participants completing nearly 3.5 million remote health evaluations over cumulative participation of 850,000 days. Median participant retention across eight studies varied widely from 2-26 days (median across all studies = 5.5 days). Survival analysis revealed several factors significantly associated with increase in participant retention time, including (i) referral by a clinician to the study (increase of 40 days in median retention time); (ii) compensation for participation (increase of 22 days, 1 study); (iii) having the clinical condition of interest in the study (increase of 7 days compared with controls); and (iv) older age (increase of 4 days). Additionally, four distinct patterns of daily app usage behavior were identified by unsupervised clustering, which were also associated with participant demographics. Most studies were not able to recruit a sample that was representative of the race/ethnicity or geographical diversity of the US. Together these findings can help inform recruitment and retention strategies to enable equitable participation of populations in future digital health research.

Study design considerations for sleep-disordered breathing devices.

None: In recent years, sleep-disordered breathing (SDB) has been recognized as a prevalent but under-diagnosed condition in adults and has prompted the need for new and better diagnostic and therapeutic options. To facilitate the development and availability of innovative, safe and effective SDB medical device technologies for patients in the United States, the US Food and Drug Administration collaborated with six SDB-related professional societies and a consumer advocacy organization to convene a public workshop focused on clinical investigations of SDB devices. Sleep medicine experts discussed appropriate definitions of terms used in the diagnosis and treatment of SDB, the use of home sleep testing versus polysomnography, clinical trial design issues in studying SDB devices, and current and future trends in digital health technologies for diagnosis and monitoring SDB. The panel's breadth of clinical expertise and experience across medical specialties provided useful and important insights regarding clinical trial designs for SDB devices.

National Expansion of Sleep Telemedicine for Veterans: The TeleSleep Program.

STUDY OBJECTIVES: (1) Review the prevalence and comorbidity of sleep disorders among United States military personnel and veterans. (2) Describe the status of sleep care services at Veterans Health Administration (VHA) facilities. (3) Characterize the demand for sleep care among veterans and the availability of sleep care across the VHA. (4) Describe the VA TeleSleep Program that was developed to address this demand. METHODS: PubMed and Medline databases (National Center for Biotechnology Information, United States National Library of Medicine) were searched for terms related to sleep disorders and sleep care in United States military and veteran populations. Information related to the status of sleep care services at VHA facilities was provided by clinical staff members at each location. Additional data were obtained from the VA Corporate Data Warehouse. RESULTS: Among United States military personnel, medical encounters for insomnia increased 372% between 2005-2014; encounters for obstructive sleep apnea (OSA) increased 517% during the same period. The age-adjusted prevalence of sleep disorder diagnoses among veterans increased nearly 6-fold between 2000-2010; the prevalence of OSA more than doubled in this population from 2005-2014. CONCLUSIONS: Most VA sleep programs are understaffed for their workload and have lengthy wait times for appointments. The VA Office of Rural Health determined that the dilemma of limited VHA sleep health care availability and accessibility might be solved, at least in part, by implementing a comprehensive telehealth program in VA medical facilities. The VA TeleSleep Program is an expansion of telemedicine services to address this need, especially for veterans in rural or remote regions. CITATION: Sarmiento KF, Folmer RL, Stepnowsky CJ, Whooley MA, Boudreau EA, Kuna ST, Atwood CW, Smith CJ, Yarbrough WC. National expansion of sleep telemedicine for veterans: the telesleep program. J Clin Sleep Med. 2019;15(9):1355-1364.

Comorbidities, Health-Related Quality of Life, and Work Productivity Among People With Obstructive Sleep Apnea With Excessive Sleepiness: Findings From the 2016 US National Health and Wellness Survey.

STUDY OBJECTIVES: Few population-based studies have explored how excessive sleepiness (ES) contributes to burden of illness among patients with obstructive sleep apnea (OSA). METHODS: This study utilized data from the annual, cross-sectional 2016 US National Health and Wellness Survey. Respondents self-reporting an OSA diagnosis were categorized as having ES (Epworth Sleepiness Scale [ESS] score ≥ 11) or not having ES (ESS score < 11). Comorbidities, health-related quality of life (HRQoL), and productivity were examined in three groups: OSA with ES (n = 731), OSA without ES (n = 1,452), and non-OSA controls (n = 86,961). RESULTS: The OSA with ES group had significantly higher proportions of respondents reporting depression (62.4% versus 48.0%), gastroesophageal reflux disease (39.0% versus 29.4%), asthma (26.3% versus 20.7%), and angina (7.8% versus 6.7%) compared to the OSA without ES group (P < .05). After controlling for covariates, the OSA with ES group had significantly lower (worse) scores for mental component score (41.81 versus 45.65 versus 47.81), physical component score (46.62 versus 48.68 versus 51.36), and SF-6D (0.65 versus 0.69 versus 0.73) compared with OSA without ES and non-OSA controls (all P < .001). The OSA with ES group had significantly higher (greater burden) mean rates of presenteeism (25.98% impairment versus 19.24% versus 14.75%), work impairment (29.41% versus 21.82% versus 16.85%), and activity impairment (31.09% versus 25.46% versus 19.93%) compared with OSA without ES and non-OSA controls (all P < .01) after controlling for covariates. CONCLUSIONS: OSA with ES is associated with higher prevalence of comorbidities, reduced HRQoL, and greater impairment in productivity compared to OSA without ES and compared to non-OSA controls.

Accelerating Research With Technology: Rapid Recruitment for a Large-Scale Web-Based Sleep Study.

BACKGROUND: Participant recruitment can be a significant bottleneck in carrying out research studies. Connected health and mobile health platforms allow for the development of Web-based studies that can offer improvement in this domain. Sleep is of vital importance to the mental and physical health of all individuals, yet is understudied on a large scale or beyond the focus of sleep disorders. For this reason and owing to the availability of digital sleep tracking tools, sleep is well suited to being studied in a Web-based environment. OBJECTIVE: The aim of this study was to investigate a method for speeding up the recruitment process and maximizing participant engagement using a novel approach, the Achievement Studies platform (Evidation Health, Inc, San Mateo, CA, USA), while carrying out a study that examined the relationship between participant sleep and daytime function. METHODS: Participants could access the Web-based study platform at any time from any computer or Web-enabled device to complete study procedures and track study progress. Achievement community members were invited to the study and assessed for eligibility. Eligible participants completed an electronic informed consent process to enroll in the study and were subsequently invited to complete an electronic baseline questionnaire. Then, they were asked to connect a wearable device account through their study dashboard, which shared their device data with the research team. The data were used to provide objective sleep and activity metrics for the study. Participants who completed the baseline questionnaires were subsequently sent a daily single-item Sleepiness Checker activity for 7 consecutive days at baseline and every 3 months thereafter for 1 year. RESULTS: Overall, 1156 participants enrolled in the study within a 5-day recruitment window. In the 1st hour, the enrollment rate was 6.6 participants per minute (394 per hour). In the first 24 hours, the enrollment rate was 0.8 participants per minute (47 participants per hour). Overall, 1132 participants completed the baseline questionnaires (1132/1156, 97.9%) and 1047 participants completed the initial Sleepiness Checker activity (1047/1156, 90.6%). Furthermore, 1000 participants provided activity-specific wearable data (1000/1156, 86.5%) and 982 provided sleep-specific wearable data (982/1156, 84.9%). CONCLUSIONS: The Achievement Studies platform allowed for rapid recruitment and high study engagement (survey completion and device data sharing). This approach to carrying out research appears promising. However, conducting research in this way requires that participants have internet access and own and use a wearable device. As such, our sample may not be representative of the general population.

Recent Advancements in Treating Sleep Disorders in Co-Occurring PTSD.

PURPOSE OF REVIEW: Comorbidity of posttraumatic stress disorder (PTSD) and insomnia, nightmares, and obstructive sleep apnea (OSA) is high. We review recent research on psychotherapeutic and pharmacological interventions for sleep disorders in PTSD. RECENT FINDINGS: PTSD treatments decrease PTSD severity and nightmare frequency, but do not resolve OSA or insomnia. Research on whether insomnia hinders PTSD treatment shows mixed results; untreated OSA does interfere with PTSD treatment. Cognitive behavioral therapy for insomnia is the recommended treatment for insomnia; however, optimal ordering with PTSD treatment is unclear. PTSD treatment may be most useful for PTSD-related nightmares. CPAP therapy is recommended for OSA but adherence can be low. Targeted treatment of sleep disorders in the context of PTSD offers a unique and underutilized opportunity to advance clinical care and research. Research is needed to create screening protocols, determine optimal order of treatment, and elucidate mechanisms between sleep and PTSD treatments.

CPAP Adherence is Associated With Attentional Improvements in a Group of Primarily Male Patients With Moderate to Severe OSA.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) is a widespread condition that adversely affects physical health and cognitive functioning. The prevailing treatment for OSA is continuous positive airway pressure (CPAP), but therapeutic benefits are dependent on consistent use. Our goal was to investigate the relationship between CPAP adherence and measures of sustained attention in patients with OSA. Our hypothesis was that the Psychomotor Vigilance Task (PVT) would be sensitive to attention-related improvements resulting from CPAP use. METHODS: This study was a secondary analysis of a larger clinical trial. Treatment adherence was determined from CPAP use data. Validated sleep-related questionnaires and a sustained-attention and alertness test (PVT) were administered to participants at baseline and at the 6-month time point. RESULTS: Over a 6-month time period, the average CPAP adherence was 3.32 h/night (standard deviation [SD] = 2.53), average improvement in PVT minor lapses was -4.77 (SD = 13.2), and average improvement in PVT reaction time was -73.1 milliseconds (standard deviation = 211). Multiple linear regression analysis showed that higher CPAP adherence was significantly associated with a greater reduction in minor lapses in attention after 6 months of continuous treatment with CPAP therapy (ß = -0.72, standard error = 0.34, P = .037). CONCLUSIONS: The results of this study showed that higher levels of CPAP adherence were associated with significant improvements in vigilance. Because the PVT is a performance-based measure that is not influenced by prior learning and is not subjective, it may be an important supplement to patient self-reported assessments. CLINICAL TRIAL REGISTRATION: Name: Effect of Self-Management on Improving Sleep Apnea Outcomes, URL: https://clinicaltrials.gov/ct2/show/NCT00310310, Identifier: NCT00310310.

Treatment of OSA with CPAP Is Associated with Improvement in PTSD Symptoms among Veterans.

STUDY OBJECTIVES: Posttraumatic stress disorder (PTSD) is common among veterans of the military, with sleep disturbance as a hallmark manifestation. A growing body of research has suggested a link between obstructive sleep apnea and PTSD, potentially due to obstructive sleep apnea (OSA) related sleep disruption, or via other mechanisms. We examined the hypothesis that treatment of OSA with positive airway pressure would reduce PTSD symptoms over 6 months. METHODS: A prospective study of Veterans with confirmed PTSD and new diagnosis of OSA not yet using PAP therapy were recruited from a Veteran's Affairs sleep medicine clinic. All subjects were instructed to use PAP each night. Assessments were performed at 3 and 6 months. The primary outcome was a reduction in PTSD symptoms at 6 months. RESULTS: Fifty-nine subjects were enrolled; 32 remained in the study at 6 months. A significant reduction in PTSD symptoms, measured by PCL-S score was observed over the course of the study (60.6 ± 2.7 versus 52.3 ± 3.2 points; p < 0.001). Improvement was also seen in measures of sleepiness, sleep quality, and daytime functioning, as well as depression and quality of life. Percentage of nights in which PAP was used, but not mean hours used per night, was predictive of improvement. CONCLUSIONS: Treatment of OSA with PAP therapy is associated with improvement in PTSD symptoms, although the mechanism is unclear. Nonetheless, PAP should be considered an important component of PTSD treatment for those with concurrent OSA. Improving PAP compliance is a challenge in this patient population warranting further investigation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02019914. COMMENTARY: A commentary on this article appears in this issue on page 5.

The state of Veterans Affairs sleep medicine programs: 2012 inventory results.

PURPOSE: The Veterans Health Administration (VHA) represents one of the largest integrated health-care systems in the country. In 2012, the Veterans Affairs Sleep Network (VASN) sought to identify available sleep resources at VA medical centers (VAMCs) across the country through a national sleep inventory. METHODS: The sleep inventory was administered at the annual 2012 VA Sleep Practitioners meeting and by email to sleep contacts at each VAMC. National prosthetics contacts were used to identify personnel at VAMCs without established sleep programs. Follow-up emails and telephone calls were made through March 2013. RESULTS: One hundred eleven VA medical centers were included for analysis. Thirty-nine programs did not respond, and 10 were considered "satellites," referring all sleep services to a larger neighboring VAMC. Sleep programs were stratified based on extent of services offered (i.e., in-lab and home testing, sleep specialty clinics, cognitive behavioral therapy for insomnia (CBT-i)): 28 % were complex sleep programs (CSPs), 46 % were intermediate (ISPs), 9 % were standard (SSPs), and 17 % offered no formal sleep services. Overall, 138,175 clinic visits and 90,904 sleep testing encounters were provided in fiscal year 2011 by 112.1 physicians and clinical psychologists, 100.4 sleep technologists, and 115.3 respiratory therapists. More than half of all programs had home testing and CBT-i programs, and 26 % utilized sleep telehealth. CONCLUSIONS: The 2012 VA sleep inventory suggests considerable variability in sleep services within the VA. Demand for sleep services is high, with programs using home testing, sleep telehealth, and a growing number of mid-level providers to improve access to care.

Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials.

Pragmatic clinical trials are designed to inform decision makers about the benefits, burdens, and risks of health interventions in real-world settings. Pragmatic clinical trials often use for research purposes data collected in the course of clinical practice. The distinctive features of pragmatic clinical trials demand fresh thinking about what is required to act properly toward people affected by their conduct, in ways that go beyond ensuring the protection of rights and welfare for "human research subjects" under conventional research ethics regulations. To stimulate such work, we propose to distinguish among categories of research participants in pragmatic clinical trials as follows: Direct participants: (1) individuals being directly intervened upon and/or (2) individuals from whom personal identifiable data are being collected for the purposes of the pragmatic clinical trial. Indirect participants: individuals who are (1) not identified as direct participants and (2) whose rights and welfare may be affected by the intervention through their routine exposure to the environment in which the intervention is being deployed. Collateral participants: patient groups and other stakeholder communities who may be otherwise affected by the occurrence and findings of the pragmatic clinical trial. We illustrate these distinctions with case examples and discuss the distinctive responsibilities of researchers and pragmatic clinical trial leadership toward each type of participant. We suggest that pragmatic clinical trial investigators, institutional review boards, health systems leaders, and others engaged in the research enterprise work together to identify these participants. For indirect participants, risks and benefits to which they are exposed should be weighed to ensure that their rights and welfare are protected accordingly, and communication strategies should be considered to help them make well-informed decisions. Collateral participants could provide input on the design, planning, and conduct of a pragmatic clinical trial and offer insights regarding the best way to communicate the trial's results to their constituencies.