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NCT05104450 · ClinicalTrials.gov registry record · NA
Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach
A NA study of Obesity and Sleep Apnea, Obstructive, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 696
- Enrollment target
- 1
- Study location
NCT05104450: Completed NA study of Obesity and Sleep Apnea, Obstructive, sponsored by VA Office of Research and Development.
NCT05104450 is a NA study of Obesity and Sleep Apnea, Obstructive that has completed, run by VA Office of Research and Development. The registered enrollment target is 696 participants, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05104450, a NA study of Obesity and Sleep Apnea, Obstructive, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 696 participants
- Enrollment target
- 1
- Study location
Study Summary
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 afte
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL lifestyle intervention
Study Locations (1)
Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 696 participants |
| Start Date | 2022-04-04 |
| Est. Completion | 2025-05-01 |
| Phase | NA |
What the finished NCT05104450 record still lists
NCT05104450 is an interventional study that assigns participants to a tested intervention. The registered 696 participants enrollment target is mid-sized for trials with a published cap, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (15% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which lifestyle intervention is the first listed.
NCT05104450 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT05104450 about?
NCT05104450 is a clinical study titled "Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach". 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,...
What is the current status of trial NCT05104450?
This trial is currently completed. It is a NA study. The enrollment target is 696 participants. The study started on 2022-04-04. Estimated completion is 2025-05-01.
What conditions does trial NCT05104450 study?
This clinical trial studies the following conditions: Obesity, Sleep Apnea, Obstructive.
What interventions are being tested in trial NCT05104450?
The interventions under investigation include: lifestyle intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05104450?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05104450 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05104450's enrollment target sits among peer trials
696 107th of 1053 higher than 947 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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