BackgroundObstructive 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. MethodsParticipants 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. ResultsThe 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. ConclusionIn 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.
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.
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.
Background: Obstructive sleep apnea is a prevalent condition with potentially serious medical and psychosocial consequences. Nasal continuous positive airway pressure (CPAP) is the ...treatment-of-choice and has been shown to reduce the frequency of nocturnal respiratory events, improve sleep architecture and decrease daytime sleepiness. Patient compliance with CPAP is disappointingly low. Previous studies examining determinants of CPAP compliance have limited the variables studied to patient (sociodemographic), disease status, and treatment variables, with few reliable determinants found.
Methods: The purpose of the current study was to investigate the relationship between objectively measured CPAP compliance and variables from social cognitive theory (SCT) and the transtheoretical model (TM). Scales that measure variables from each model were developed and reliability evaluated. The relationship between the SCT and TM variables and compliance at 1-month post-CPAP-fitting was prospectively evaluated on 51 first-time CPAP users. SCT and TM variables were measured on the day of CPAP-fitting, at 1-week post-CPAP-fitting, and at 1-month post-CPAP-fitting.
Results: SCT variables measured 1-week post-CPAP-fitting (
R
2=0.261,
P=0.001) and TM variables measured 1-week post-CPAP-fitting (
R
2=0.17,
P=0.002) accounted for a statistically significant amount of variance in objective CPAP compliance measured at 1 month. The decisional balance index (from TM) individually accounted for a significant amount of variance in objective CPAP compliance in the above analyses.
Conclusions: The ability of these new behavior change scales to predict CPAP compliance provides us with a new direction of research to better understand factors associated with compliance. The principal advantage of these theory-driven and empirically validated scales are that they measure modifiable factors that can provide the basis for sound interventions to improve CPAP compliance.
Abstract
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.
To explore the relationship between psychologic variables measured prior to continuous positive airway pressure (CPAP) treatment and subsequent CPAP compliance.
Participants were assigned to a CPAP ...treatment group. Psychologic questionnaires administered prior to the start of treatment assessed depression, anxiety, stress, anger or hostility, social support, social desirability, and coping. Polysomnography was performed on admission (prior to start of treatment) and at the end of 1 week of treatment. Compliance was measured nightly by an intemal clock counter in the CPAP unit and averaged over the 1-week treatment period.
N/A.
Twenty-three CPAP-naive patients with obstructive sleep apnea were enrolled in a study of the effects of CPAP on sympathetic nervous system functioning, quality of life, and psychologic functioning.
N/A.
Objectively measured average daily compliance was significantly associated with a measure of coping strategies. Multiple regression analyses revealed that Active Ways of Coping accounted for a significant amount of variance in CPAP compliance, even after the respiratory disturbance index, daytime sleepiness, and Passive Ways of Coping were taken into account. No other psychologic variable assessed prior to CPAP treatment was associated with subsequent CPAP compliance.
These results suggest that individuals who engage in active coping strategies with new and difficult situations used CPAP more. It may be that encouraging patients to use coping techniques, such as planful problem solving, will help to improve compliance with CPAP.
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.
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.
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.
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%).
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.
Abstract 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.
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