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Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach
NA trial testing lifestyle intervention in Obesity in 696 participants. Completed in 1 May 2025.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 696 |
| Start date | 4 April 2022 |
| Primary completion | 1 August 2024 |
| Estimated completion | 1 May 2025 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
18 and older, any sex, with Obesity or Sleep Apnea, Obstructive. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The investigators will compare change in Functional Outcomes of Sleep questionnaire (FOSQ) score between groups. The minimum value of FOSQ is 5, the maximum is 20, and a higher value indicates a better outcome.
| Group | Value | 95% CI |
|---|---|---|
| Lifestyle Intervention | 1.43 | ± 2.73 |
| Usual Care Control | 0.93 | ± 2.89 |
The investigators will compare change in weights between intervention and control using clinic weights from VA medical record
| Group | Value | 95% CI |
|---|---|---|
| Lifestyle Intervention | -2.10 | ± 6.75 |
| Usual Care Control | -0.88 | ± 5.86 |
The investigators will compare change in cardiovascular risk scores between intervention and control using the non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease (worse outcome).
| Group | Value | 95% CI |
|---|---|---|
| Lifestyle Intervention | 0.22 | ± 3.47 |
| Usual Care Control | -0.20 | ± 3.65 |
The investigators will compare change in sleep disturbance between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance (worse outcome).
| Group | Value | 95% CI |
|---|---|---|
| Lifestyle Intervention | -3.34 | ± 7.69 |
| Usual Care Control | -3.02 | ± 6.76 |
The investigators will compare change in sleep-related impairment between intervention and control using the Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. Individuals' responses are used to generate a T-score, corresponding to a population mean of 50 with standard deviation of 10. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment (worse outcome).
| Group | Value | 95% CI |
|---|---|---|
| Lifestyle Intervention | -5.67 | ± 8.84 |
| Usual Care Control | -3.13 | ± 7.76 |
The investigators will compare change in systolic blood pressure values between intervention and control.
| Group | Value | 95% CI |
|---|---|---|
| Lifestyle Intervention | -0.22 | ± 15.73 |
| Usual Care Control | -2.26 | ± 15.06 |
The investigators will compare change in daily OSA treatment usage between groups using self-report.
| Group | Value | 95% CI |
|---|---|---|
| Lifestyle Intervention | 1.04 | ± 2.99 |
| Usual Care Control | 1.58 | ± 3.48 |
The investigators will conduct home sleep apnea tests among a subset of patients in each group to compare apnea hypopnea index (a physiologic measure of OSA severity) between groups at 12 months. The apnea hypopnea index measures the number of times per hour of sleep in which an individual stops breathing (apnea) or nearly stops breathing (hypopnea). For this outcome, we will measure apneas and hypopneas using the 1B criteria of the American Academy of Sleep Medicine.
| Group | Value | 95% CI |
|---|---|---|
| Lifestyle Intervention | 13.77 | ± 14.53 |
| Usual Care Control | 16.49 | ± 17.73 |
The investigators will compare longer-term change in weight between intervention and control using clinic weights from VA medical record
| Group | Value | 95% CI |
|---|---|---|
| Lifestyle Intervention | -2.64 | ± 7.71 |
| Usual Care Control | -1.98 | ± 7.79 |
The investigators will compare short-term change in Functional Outcomes of Sleep questionnaire (FOSQ) between groups. The minimum value of FOSQ is 5, the maximum is 20, and a higher value indicates a better outcome.
| Group | Value | 95% CI |
|---|---|---|
| Lifestyle Intervention | 1.30 | ± 2.34 |
| Usual Care Control | 0.67 | ± 2.35 |
The investigators will compare longer-term change in Functional Outcomes of Sleep questionnaire (FOSQ) between groups. The minimum value of FOSQ is 5, the maximum is 20, and a higher value indicates a better outcome.
| Group | Value | 95% CI |
|---|---|---|
| Lifestyle Intervention | 1.29 | ± 3.08 |
| Usual Care Control | 0.96 | ± 2.89 |
The investigators will compare perceived change in symptoms between groups using the single-item patients' global impression of change (PGI-C). PGI-C has been validated in the context of OSA treatment and asks patients to rate symptom changes on a 7 point scale from "1-Very Much Improved" to "7-Very Much Worse".
| Group | Value | 95% CI |
|---|---|---|
| Lifestyle Intervention | 3.29 | ± 1.00 |
| Usual Care Control | 3.40 | ± 1.00 |
Time frame: We systematically collected adverse events (AE) by body system as part of the the 12- and 21-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition. We also systematically reviewed the electronic health record for discharge summaries among all participants at 12 months, and at 21 month follow-up among those who did not complete follow-up surveys.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lifestyle Intervention | Usual Care Control |
|---|---|---|---|
| Cardiovascular | Cardiac disorders | — | — |
| Gastrointestinal | Gastrointestinal disorders | — | — |
| Musculoskeletal | Musculoskeletal and connective tissue disorders | — | — |
| Neurological | Nervous system disorders | — | — |
| Pulmonary/Respiratory | Respiratory, thoracic and mediastinal disorders | — | — |
| Renal/Urologic | Renal and urinary disorders | — | — |
| Hematological | Blood and lymphatic system disorders | — | — |
| Other | General disorders | — | — |
| Psychological | Psychiatric disorders | — | — |
| Hepatobiliary | Hepatobiliary disorders | — | — |
| Metabolic | Metabolism and nutrition disorders | — | — |
| Dermatological | Skin and subcutaneous tissue disorders | — | — |
| Reaction | System | Lifestyle Intervention | Usual Care Control |
|---|---|---|---|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | — | — |
| Cardiovascular | Cardiac disorders | — | — |
| Gastrointestinal | Gastrointestinal disorders | — | — |
| Other | General disorders | — | — |
| Pulmonary/Respiratory | Respiratory, thoracic and mediastinal disorders | — | — |
| Renal/Urologic | Renal and urinary disorders | — | — |
| Neurological | Nervous system disorders | — | — |
| Dermatological | Skin and subcutaneous tissue disorders | — | — |
| Psychological | Psychiatric disorders | — | — |
| Metabolic | Metabolism and nutrition disorders | — | — |
| Hepatobiliary | Hepatobiliary disorders | — | — |
| Hematological | Blood and lymphatic system disorders | — | — |
Most-reported serious reactions: Cardiovascular, Gastrointestinal, Musculoskeletal, Neurological, Pulmonary/Respiratory, Renal/Urologic, Hematological, Other.
Data from ClinicalTrials.gov NCT05104450 adverse events section.
Prevalent obesity related conditions like obstructive sleep apnea (OSA) represent an important opportunity to improve population health. OSA reduces quality of life and is associated with greater risk for cardiovascular disease. Although obesity is the single greatest reversible risk factor for OSA, patients with OSA and obesity rarely receive weight loss care to reverse OSA and other serious comorbidities. Efficacy trials reinforce that time and resource intensive lifestyle-based weight loss programs improve weight and physiologic measures of OSA severity (apnea hypopnea index, AHI). However, there are barriers to translating these findings into meaningful gains for population health. To meet these challenges, the investigators propose a pragmatic trial of proactively offering a remote video-based and self-directed lifestyle-based weight loss intervention with remote coaching to patients with OSA. The investigators primary aim is to test the effectiveness of a proactively delivered and pragmatic lifestyle intervention to improve co-primary endpoints of sleep-related quality of life and weight among patients with OSA and obesity. Secondarily, the investigators will compare additional outcomes between groups including cardiovascular risk scores, sleep symptoms, AHI, well-being, and global ratings of change. Finally, the investigators will also conduct an implementation process evaluation informed by the RE-AIM framework to identify barriers and facilitators to widespread implementation. The investigators will identify patients with OSA and obesity nationwide (n=696) in VA using data from the VA's Corporate Data Warehouse (CDW), and the investigators will contact potentially eligible patients. After confirming eligibility and consent, the investigators will randomly assign subjects to receive the study's lifestyle intervention or usual care alone. The study uses CDW to assess weight change. Subjects will complete questionnaires at baseline at 3, 12 and 21 months after randomization. The lifestyle intervention in POWER focuses on gradual lifestyle behavior change aimed at improving eating habits and increasing physical activity. It encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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