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Behavioral Intervention

Lifestyle Intervention for Obstructive Sleep Apnea (POWER Trial)

N/A
Waitlist Available
Led By Lucas M Donovan, MD MS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of obstructive sleep apnea (OSA) on sleep study (sleep provider confirmed)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to between 18 and 24 months post randomization
Awards & highlights

POWER Trial Summary

This trial is testing the effectiveness of a proactively delivered and pragmatic lifestyle intervention to improve sleep-related quality of life and weight among patients with OSA and obesity.

Who is the study for?
This trial is for individuals with obstructive sleep apnea (OSA) and obesity, having a BMI between 30.0-44.9 kg/m2. Participants should have access to digital media for the intervention and be able to fully engage in study procedures. Those actively in weight loss programs, with certain health conditions or life expectancies under two years, pregnant women, or non-English speakers are excluded.Check my eligibility
What is being tested?
The trial tests a remote lifestyle intervention aimed at improving sleep-related quality of life and reducing weight in patients with OSA and obesity. It involves video-based education, self-guided materials on diet and exercise over a year, with support from a lifestyle coach compared to usual care.See study design
What are the potential side effects?
As this is a lifestyle intervention focusing on diet changes and increased physical activity rather than medication or surgery, side effects may include muscle soreness from new exercises or adjustments to dietary changes but are generally minimal compared to drug treatments.

POWER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with obstructive sleep apnea.

POWER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to between 18 and 24 months post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to between 18 and 24 months post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
change in sleep-related quality of life
change in weight
Secondary outcome measures
Global Rating of Change
PROMIS - Sleep Disturbance Survey change
PROMIS - Sleep Related Impairment Survey change
+10 more

POWER Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: lifestyle interventionExperimental Treatment1 Intervention
The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.
Group II: usual care controlActive Control1 Intervention
Participants in this arm will continue with usual care without the lifestyle intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lifestyle intervention
2022
Completed Phase 4
~2550

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,305,733 Total Patients Enrolled
40 Trials studying Obesity
9,391 Patients Enrolled for Obesity
Lucas M Donovan, MD MSPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA

Media Library

Lifestyle Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05104450 — N/A
Obesity Research Study Groups: usual care control, lifestyle intervention
Obesity Clinical Trial 2023: Lifestyle Intervention Highlights & Side Effects. Trial Name: NCT05104450 — N/A
Lifestyle Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05104450 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial actively recruiting participants?

"The public record on clinicaltrials.gov attests to the fact that this medical study, which was initially posted on April 4th 2022 and later revised on September 12th 2022, is not enrolling patients at present. Nevertheless, there are 1348 other trials actively recruiting participants across the country."

Answered by AI

What results are researchers hoping to achieve with this research endeavor?

"The main outcome of this trial, assessed from baseline to 12 months post-baseline, will be changes in weight. Other objectives include a comparison of Apnea Hypopnea Index (AHI), Functional Outcomes of Sleep Questionnaire (FOSQ) scores and OSA treatment usage between groups. AHI measures the number of times an individual stops breathing per hour during sleep; FOSQ is scored on a 5-20 scale with higher values indicating better outcomes; PAP usage can be tracked remotely for objective evaluation."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
What site did they apply to?
VA Puget Sound Health Care System Seattle Division, Seattle, WA
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach
2022. "Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05104450.
All > Apnea > Diet
~77 spots leftby Aug 2024
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