Lifestyle Intervention for Obstructive Sleep Apnea

(POWER Trial)

Overseen By Jennifer McDowell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Weight-loss medications

Disqualifiers: Bariatric surgery, Pregnancy, Severe health issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a video-based lifestyle program can help individuals with obstructive sleep apnea (OSA) and obesity improve sleep quality and lose weight. Participants will either continue with their usual care or receive additional support through a lifestyle intervention. This program includes behavioral therapy, dietary counseling, and physical activity to promote better eating habits and increased physical activity. The trial aims to determine if these changes can also reduce heart disease risks and enhance overall well-being. Individuals diagnosed with OSA and a body mass index (BMI) between 30 and 44.9 may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative lifestyle changes that could enhance health and well-being.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using prescription weight-loss medications, you would not be eligible to participate.

What prior data suggests that this lifestyle intervention is safe for patients with obstructive sleep apnea and obesity?

Research has shown that lifestyle changes, like losing weight and being more active, are generally safe for people with obstructive sleep apnea (OSA). One study found that an 8-week lifestyle program improved OSA symptoms without causing major side effects compared to usual care. Participants did not face significant safety issues during the program.

Another study found that following a Mediterranean diet and making lifestyle changes aided weight loss and improved adherence to positive airway pressure (PAP) therapy, a common treatment for sleep apnea. No serious safety concerns were reported.

Overall, evidence suggests that lifestyle changes, such as regular exercise and healthy eating, are safe for people with OSA and can offer health benefits without causing significant harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the lifestyle intervention for obstructive sleep apnea because it offers a non-invasive alternative to standard treatments like CPAP machines and oral appliances. Unlike these traditional methods, which primarily focus on managing symptoms, this intervention targets the root causes by encouraging sustainable behavioral changes such as improved diet, exercise, and sleep habits. This approach not only aims to reduce sleep apnea symptoms but also promotes overall health and well-being, potentially offering a holistic and long-term solution.

What evidence suggests that this lifestyle intervention is effective for obstructive sleep apnea?

Research has shown that lifestyle changes, such as improving diet and increasing exercise, can significantly aid in managing obstructive sleep apnea (OSA). In this trial, participants in the lifestyle intervention arm will receive a behavioral lifestyle intervention alongside usual care. One study found that an eight-week program focused on weight loss and lifestyle changes reduced OSA symptoms more effectively than standard care. Another study found that a year-long lifestyle program helped maintain improvements in mild OSA. Weight loss through these changes also benefits other health areas, such as lowering blood pressure and facilitating the use of treatments like CPAP, a machine that aids breathing during sleep. Overall, evidence supports that lifestyle changes can effectively reduce the symptoms and severity of OSA, particularly for individuals who are overweight or obese. ^{1 4 5 6 7}

Who Is on the Research Team?

Lucas M Donovan, MD MS

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a lifestyle-based weight loss intervention with remote coaching, focusing on gradual lifestyle behavior change aimed at improving eating habits and increasing physical activity.

12 months

Remote video-based sessions and self-directed learning

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 12, and 21 months post-randomization.

21 months

Questionnaires at 3, 12, and 21 months

Implementation Process Evaluation

Conduct an implementation process evaluation informed by the RE-AIM framework to identify barriers and facilitators to widespread implementation.

Concurrent with treatment and follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: lifestyle intervention Experimental Treatment 1 Intervention

The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.

Group II: usual care control Active Control 1 Intervention

Participants in this arm will continue with usual care without the lifestyle intervention.

Lifestyle Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Lifestyle Intervention for:

• Obesity
• Weight Loss
• Type 2 Diabetes Prevention

Approved in European Union as Lifestyle Intervention for:

• Obesity
• Overweight
• Weight-Related Diseases

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3773205/

Effectiveness of Lifestyle Interventions on Obstructive Sleep ... Conclusions: Published evidence suggests that weight loss through lifestyle and dietary interventions results in improvements in obstructive sleep apnea ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06382883

Lifestyle and Physical Activity as Part Of Obstructive Sleep ... In this study, it is hypothesized that participants receiving SEMC-intervention in combination with CPAP therapy will experience greater alleviation of OSA ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523019809

Sustained improvement in mild obstructive sleep apnea ... Conclusion: Favorable changes achieved by a 1-y lifestyle intervention aimed at weight reduction with a healthy diet and physical activity were sustained in ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2791455

Effect of an Interdisciplinary Weight Loss and Lifestyle ... An 8-week interdisciplinary weight loss and lifestyle intervention significantly improved OSA severity and other outcomes compared with usual care alone.

5. mdpi.com mdpi.com/2075-1729/13/8/1755

A Dietary and Lifestyle Intervention Improves Treatment ... In conclusion, our results provide evidence that overweight/obese patients with moderate to severe OSA can benefit significantly in terms of PAP adherence, BP, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025004626

Effect of sleep apnoea interventions on multiple health ... This umbrella review identified CPAP as the most effective intervention for reducing AHI and daytime sleepiness in patients with OSA, while physical activity ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9034401/

Effect of an Interdisciplinary Weight Loss and Lifestyle ... An 8-week interdisciplinary weight loss and lifestyle intervention significantly improved OSA severity and other outcomes compared with usual care alone.