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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.

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. Summary 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.

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.

(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. 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. 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. 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. 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.

Abstract 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.

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. Measurement(s) Demographic Data • Alcohol Consumption • Smoking Behavior • Socioeconomic Factors • Personal Medical History • Sleepiness • Sleep Quality • Objective Alertness Technology Type(s) Survey • Epworth Sleepiness Scale Questionnaire • Pittsburgh Sleep Quality Index • Psychomotor Vigilance Task 3-Minute Version (PVT-B) Sample Characteristic - Organism Homo sapiens Sample Characteristic - Location United States of America Machine-accessible metadata file describing the reported data: https://doi.org/10.6084/m9.figshare.12647108

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. 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. 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. 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. 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.

Introduction The Psychomotor Vigilance Test is a well-validated measure of sustained attention used to assess daytime alertness in sleep research studies.1 It is commonly used in a variety of research settings due to its high sensitivity to sleep loss and absence of learning effects,2 making it an ideal tool to assess objective alertness. As some types of sleep research transition out of controlled laboratory environments, tools like the PVT require modification to maximize their reliability. The validation of the 3-minute version (PVT-B) against the 10-minute PVT is an example of this modification.3 However, considerable work is needed to improve trust in the utility of the PVT-B in and outside of traditional laboratory settings. Methods We carefully analyzed data from a mobile-based version of the PVT-B, noting responses that occurred during the interstimulus interval which were termed “wrong taps.” Wrong taps indicated that participants were not performing the task as instructed. In some cases, wrong taps occurred across multiple trials of the same PVT block, indicative of participants repeatedly tapping the screen throughout the task to minimize response times. A comprehensive examination of wrong taps was carried out in order to identify instances where this pattern emerged. Results A total of 1,338,538 PVT-B trials from 7,028 participants were examined to determine the number of wrong taps present across all trials. While 91.7% of PVT-B trials were free of wrong taps, 8.3% of PVT-B trials contained 1 or more wrong taps and 5.2% contained 2 or more wrong taps. It appears that a maximum of one wrong tap per trial is acceptable and trials containing 2 or more should be excluded to maximize PVT data quality. Conclusion Utilizing a metric like wrong taps can help identify individuals taking the PVT-B who are tapping the screen multiple times prior to stimulus display. Closely examining this metric can help to ensure the validity of PVT-B administrations. Two possible uses of the metric could be to provide feedback during training trials and to remove trials where this strategy was employed. Support (if any) This analysis was supported by the VA San Diego Healthcare System Research Service.

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. Citation: Mann EA, Nandkumar S, Addy N, et al. Study design considerations for sleep-disordered breathing devices. J Clin Sleep Med . 2020;16(3):441–449.