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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
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with obstructive sleep apnea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to between 18 and 24 months post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to between 18 and 24 months post randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
change in sleep-related quality of life
change in weight
Secondary study objectives
Global Rating of Change
PROMIS - Sleep Disturbance Survey change
PROMIS - Sleep Related Impairment Survey change
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~2850
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,360,942 Total Patients Enrolled
Lucas M Donovan, MD MSPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have serious physical or mental health problems, or are not expected to live more than 2 years.My weight changes a lot because of fluid buildup.I am losing weight due to another illness.I can follow all study rules and give my informed consent.I have been diagnosed with obstructive sleep apnea.Your body mass index (BMI) has been between 30.0 and 44.9 in the past year.I am currently trying to lose weight through medication, programs, or surgery.You are currently involved in other research studies.
Research Study Groups:
This trial has the following groups:- Group 1: usual care control
- Group 2: lifestyle intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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