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.

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.

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.

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.

The hepatitis C self-management program: sustainability of primary outcomes at 1 year.

OBJECTIVE: Chronic hepatitis C infection afflicts millions of people worldwide. Although antiviral treatments are increasingly effective, many hepatitis C virus (HCV) patients avoid treatment, do not complete or respond to treatment, or have contraindications. Self-management interventions are one option for promoting behavioral changes leading to liver wellness and improved quality of life. Our objective was to evaluate whether the effects of the HCV self-management program were sustained at the 12-month follow-up assessment. METHODS: Veteran Affairs patients with hepatitis C (N = 134; mean age = 54.6 years, 95% male, 41% ethnic minority, 48% homeless in last 5 years) were randomized to either a 6-week self-management workshop or an information-only intervention. The weekly 2-hour self-management sessions were based on a cognitive-behavioral program with hepatitis C-specific modules. Outcomes including hepatitis C knowledge, depression, energy, and health-related quality of life were measured at baseline, 6 weeks, 6 months, and 12 months later. Data were analyzed using repeated measures ANOVA. RESULTS: Compared with the information-only group, participants attending the self-management workshop improved more on HCV knowledge (p < .005), SF-36 energy/vitality (p = .016), and the Quality of Well-Being Scale (p = .036). Similar trends were found for SF-36 physical functioning and Center for Epidemiologic Studies Short Depression Scale. CONCLUSION: Better outcomes were sustained among self-management participants at the 12-month assessment despite the intervention only lasting 6 weeks. HCV health care providers should consider adding self-management interventions for patients with chronic HCV.

Mood Predicts Response to Placebo CPAP.

Study Objectives. Continuous positive airway pressure (CPAP) therapy is efficacious for treating obstructive sleep apnea (OSA), but recent studies with placebo CPAP (CPAP administered at subtherapeutic pressure) have revealed nonspecific (or placebo) responses to CPAP treatment. This study examined baseline psychological factors associated with beneficial effects from placebo CPAP treatment. Participants. Twenty-five participants were studied with polysomnography at baseline and after treatment with placebo CPAP. Design. Participants were randomized to either CPAP treatment or placebo CPAP. Baseline mood was assessed with the Profile of Mood States (POMS). Total mood disturbance (POMS-Total) was obtained by summing the six POMS subscale scores, with Vigor weighted negatively. The dependent variable was changed in apnea-hypopnea index (ΔAHI), calculated by subtracting pre- from post-CPAP AHI. Negative values implied improvement. Hierarchical regression analysis was performed, with pre-CPAP AHI added as a covariate to control for baseline OSA severity. Results. Baseline emotional distress predicted the drop in AHI in response to placebo CPAP. Highly distressed patients showed greater placebo response, with a 34% drop (i.e., improvement) in AHI. Conclusion. These findings underscore the importance of placebo-controlled studies of CPAP treatment. Whereas such trials are routinely included in drug trials, this paper argues for their importance even in mechanical-oriented sleep interventions.

Fatigue in sleep apnea: the role of depressive symptoms and self-reported sleep quality.

UNLABELLED: OBJECTIVES OR BACKGROUND: Obstructive Sleep Apnea (OSA) is characterized by partial or complete cessation of breath during sleep. OSA is associated with increased cardiovascular risk as well as psychosocial complications such as daytime somnolence, depression, and fatigue. The goal of the present study was to better understand fatigue in OSA by examining self-reported sleep quality, depressive symptoms, excessive daytime sleepiness, and OSA severity in a group of newly diagnosed OSA patients. METHODS: Two hundred and forty newly diagnosed OSA patients enrolled in the study. Participants completed several questionnaires at baseline. RESULTS: Depressive symptoms accounted for 15% of variance in fatigue beyond that of demographics and OSA severity (p<0.001). Self-reported sleep quality accounted for 11% of variance beyond that of depressive symptoms (p<0.001). The total model accounted for 48% of the variance in fatigue. Post hoc analysis found that the total model accounted for only 14% of the variance in sleepiness (as measured by the Epworth Sleepiness Scale). CONCLUSION: The current study confirms the findings of previous OSA studies, which found depressive symptoms have a greater association with fatigue than OSA disease severity variables. This study extends those findings by showing that self-reported sleep quality is independently associated with fatigue, even after taking into account demographic, comorbid conditions, OSA disease severity, sleepiness, and depressive symptoms. The role of sleep quality as an independent contributor to daytime fatigue in OSA may be under appreciated. Sleep quality should be closely followed in the clinical management of OSA.

Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea.

BACKGROUND: Obstructive sleep apnea (OSA) is a prevalent and serious medical condition characterized by repeated complete or partial obstructions of the upper airway during sleep and is prevalent in 2% to 4% of working middle-aged adults. Nasal continuous positive airway pressure (CPAP) is the gold-standard treatment for OSA. Because compliance rates with CPAP therapy are disappointingly low, effective interventions are needed to improve CPAP compliance among patients diagnosed with OSA. OBJECTIVE: The aim was to determine whether wireless telemonitoring of CPAP compliance and efficacy data, compared to usual clinical care, results in higher CPAP compliance and improved OSA outcomes. METHODS: 45 patients newly diagnosed with OSA were randomized to either telemonitored clinical care or usual clinical care and were followed for their first 2 months of treatment with CPAP therapy. CPAP therapists were not blinded to the participants' treatment group. RESULTS: 20 participants in each group received the designated intervention. Patients randomized to telemonitored clinical care used CPAP an average of 4.1 +/- 1.8 hours per night, while the usual clinical care patients averaged 2.8 +/- 2.2 hours per night (P = .07). Telemonitored patients used CPAP on 78% +/- 22% of the possible nights, while usual care patients used CPAP on 60% +/- 32% of the nights (P = .07). No statistically significant differences between the groups were found on measures of CPAP efficacy, including measures of mask leak and the Apnea-Hypopnea Index. Patients in the telemonitored group rated their likelihood to continue using CPAP significantly higher than the patients in the usual care group. Patients in both groups were highly satisfied with the care they received and rated themselves as "not concerned" that their CPAP data were being wirelessly monitored. CONCLUSIONS: Telemonitoring of CPAP compliance and efficacy data and rapid use of those data by the clinical sleep team to guide the collaborative (ie, patient and provider) management of CPAP treatment is as effective as usual care in improving compliance rates and outcomes in new CPAP users. This study was designed as a pilot-larger, well-powered studies are necessary to fully evaluate the clinical and economic efficacy of telemonitoring for this population.

A self-management approach to improving continuous positive airway pressure adherence and outcomes.

Obstructive sleep apnea (OSA) is a condition with serious medical and psychosocial consequences. Low patient adherence to nasal continuous positive airway pressure (CPAP) limits the effectiveness of treatment. Intervention studies based on intensive support protocols have shown modest improvement in CPAP adherence; however, this approach would require significant resources and effort for integration into the existing U.S. health care system. The purpose of this article is to describe the self-management approach to chronic illness, justify the self-management approach as applied to sleep apnea patients prescribed CPAP, and to report initial pilot data on feasibility and efficacy of the Sleep Apnea Self-Management Program. CPAP adherence measured at the end of the 4-session program averaged 5.5 +/- 2.3 hr per night. The Sleep Apnea Self-Management Program (SASMP) has the potential to be an effective and practical way to improve CPAP adherence and is designed for integration into current OSA clinical processes.

Social-cognitive correlates of CPAP adherence in experienced users.

BACKGROUND AND PURPOSES: Obstructive sleep apnea (OSA) is a condition with serious medical and psychosocial consequences. However, poor adherence with nasal continuous positive airway pressure (CPAP) treatment limits the effectiveness of treatment. Behavior change factors offer one avenue of research to better understand the correlates of CPAP adherence. PATIENTS AND METHODS: Fifty-eight participants who had been diagnosed with OSA and prescribed CPAP treatment agreed to complete questionnaires that assessed sleep apnea symptoms, behavior change factors, and CPAP side effects, and to have their CPAP data downloaded. Behavior change factors from both social cognitive theory (SCT) and the transtheoretical model (TM) were assessed. The primary aim of the study was to examine the relationship between these social-cognitive factors and objectively measured CPAP adherence. RESULTS: Participants had been using CPAP for a mean of 2.1 years. SCT variables (adjusted R(2)=0.115, P=.008) and TM variables (adjusted R(2)=0.157, P<.0001) each accounted for a statistically significant amount of variance in CPAP adherence. CONCLUSIONS: The results suggest that social-cognitive factors may be associated with CPAP adherence in experienced CPAP users. The principal advantage to these theory-driven and empirically validated factors is that they are modifiable and can provide the basis for effective interventions to increase CPAP adherence.

The anatomic basis for the acquisition of speech and obstructive sleep apnea: evidence from cephalometric analysis supports The Great Leap Forward hypothesis.

BACKGROUND AND PURPOSE: We previously postulated how evolutionary changes in man's upper respiratory tract to facilitate speech, a phenomenon Jared Diamond calls The Great Leap Forward, have predisposed man to obstructive sleep apnea (OSA) [Diamond J. The Third Chimpanzee: the evolution and future of the human animal. New York: HarperCollins Publishers; 1992. p. 21, 23, 32-54, 54-6; Davidson TM. The Great Leap Forward: the anatomic evolution of obstructive sleep apnea. Sleep Medicine 2003;4:185-94]. We grouped these anatomic changes into four categories: klinorynchy, laryngeal descent, craniobase angulation and supralaryngeal vocal tract (SVT) ratio of SVT(H):SVT(V). This study was designed to investigate the relationship between cephalometric measures corresponding to these anatomic changes and OSA. PATIENTS AND METHODS: One hundred and twenty-three male subjects presenting with symptoms of OSA underwent unattended multi-channel home sleep studies. We obtained cephalometric measurements from standard lateral cephalograms. Pearson correlation coefficients were calculated between cephalometrics and apnea-hypopnea index (AHI), age, and body mass index (BMI). RESULTS: Our results showed significant correlation between AHI and klinorynchy, laryngeal descent, and craniobase angulation. CONCLUSIONS: Overall, our data supports the theory that evolutionary anatomic changes to facilitate speech correlate with OSA severity. The cumulative changes in each cephalometric category trended in the directions hypothesized and support the Great Leap theory of OSA evolution.

Nightly variability of sleep-disordered breathing measured over 3 nights.

OBJECTIVE: To examine the nightly variability of sleep-disordered breathing (SDB) as measured by the apnea-hypopnea index (AHI). STUDY DESIGN AND SETTING: Retrospective comparison of 3 sequential nights of testing performed in the home in 1091 patients who were referred for diagnostic testing of SDB. RESULTS: The Pearson and Intraclass correlation coefficients ranged between 0.88 and 0.90 for each pair of nights. Based on night 1, approximately 90% of patients were classified consistently with "AHI-high" (the highest AHI measured across the 3 nights) using an AHI threshold of 5. However, 10% were misclassified on night 1 relative to the highest AHI level. CONCLUSION AND SIGNIFICANCE: These findings suggest that (1) 1 night of diagnostic testing for SDB is not sufficient to diagnosis SDB in approximately 1 of every 10 cases, and (2) there is little, if any, significant nightly change in SDB in the home environment. EBM RATING: D.

Socioeconomic status is associated with nocturnal blood pressure dipping.

OBJECTIVE: With the advent of ambulatory blood pressure monitoring has come the awareness that blood pressure (BP) normally drops, or "dips," at night by roughly 10%. A number of pathological conditions have been associated with the nondipping of nocturnal BP. In general, researchers have looked at dipping in neurological and cardiovascular disorders. We examined the extent to which nocturnal nondipping might be influenced by relatively gross measures of social environment. METHODS: This study examined 78 healthy adults and adults with mild hypertension who were not currently receiving medication, aged 25 to 52 years (mean age = 38.2). Forty-two participants self-identified as black and 36 identified as white. RESULTS: Age, body mass index, apnea-hypopnea index, screening BP, ethnicity, and socioeconomic status (SES) were significantly associated with nocturnal BP dipping, accounting for 41% of the variance in dipping (F[6,51] = 5.473, p <.001). When SES was entered on the last step of a hierarchical regression analysis, it independently accounted for 8% of the variance in dipping, even after accounting for ethnicity, such that the lower the SES, the more the nondipping. CONCLUSION: It remains to be seen what aspect of the social environment may be driving this association between nondipping and lower social class. However, investigators might consider including social class in their models in future studies.

The effect of measurement unreliability on sleep and respiratory variables.

INTRODUCTION: Unreliability associated with scoring sleep variables is a potentially problematic issue in clinical and research studies. When scoring unreliability is unrecognized, it can contribute to the following: increase variability in the measures of interest, decrease a study's ability to detect important relationships, attenuate correlation coefficients, and increase clinical trial costs. METHODS: This paper first models the relationship between scoring variability and reliability in commonly studied sleep variables. The paper then models the relationship between unreliability and sample size requirements and statistical power. Standard methods are used to model reliability using the intraclass correlation coefficient. RESULTS: The analysis shows that when scoring unreliability is minimized (i.e., scoring reliability is maximized), correlation coefficients are more robust, sample size requirements are reduced, statistical power is increased, and clinical trial costs are reduced. DISCUSSION: When scoring unreliability is recognized, research studies can compensate by increasing the number of research subjects studied; however, it is at the cost of increasing the costs of research and exposing greater numbers of subjects to possible study risks. An effective solution is to implement rigorous initial and ongoing training efforts to maintain high inter-rater and intra-rater reliability coefficients.