ObesityPOWERNCT05104450

Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach

A study testing lifestyle intervention in people with Obesity and Sleep Apnea, Obstructive, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Obesity, Sleep Apnea, Obstructive
What is being tested?: lifestyle intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 696 participants
Where: 1 siteUnited States
Study dates: 4 Apr 2022to 1 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of obstructive sleep apnea (OSA) on sleep study (sleep provider confirmed)
Recent body mass index between 30.0-44.9 kg/m2 and at least one additional plausible BMI in last 12 months
Access to DVD player, computer, and/or internet
Able to participate fully in all study protocol/procedures including informed consent

Who cannot join

Inability to speak, read, or understand English
Recent or active weight loss interventions including use of prescription weight-loss medications, participation in group or individual weight loss programs provided by trained personnel, and prior bariatric surgery or plans for bariatric surgery during the study period.
Expected weight loss because of alternate explanations such as from illness
High variability in weight due to fluctuations in volume status (e.g. ascites - liver disease, chronic heart failure)
Safety and/or adherence concerns due to severe physical or mental health issues, or life expectancy <24 months
Pregnant, lactating, or planning to become pregnant during the study period
Participation in other intervention studies

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532

Other trials in United States

About this study

Official title: Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach (POWER)

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.

Read the detailed description

Objective(s) and Hypotheses: The investigators' primary aim is to test the effectiveness of a proactively delivered and pragmatic weight loss intervention to improve co-primary endpoints of sleep-related quality of life and weight among Veterans with obstructive sleep apnea (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. The investigators will also conduct an implementation process evaluation informed by the RE-AIM framework to identify predictors and determinants of population uptake of the intervention.
Research Design: The investigators plan a hybrid type 1 pragmatic randomized controlled trial assessing effectiveness and an implementation process evaluation.
Methodology The investigators will proactively identify patients with OSA and obesity nationwide in VA using data from the CDW (n=696), randomizing patients 1:1 to usual care plus the lifestyle-based weight loss intervention or usual care alone. The investigators will collect primary outcomes at 12 months, but will also collect outcomes at 3 and up to 21 months to assess trends over time.
Findings/Progress to Date:

Recruitment and outcome collection completed, analysis is ongoing and not yet complete.

Conditions: Obesity, Sleep Apnea, Obstructive
Being tested: lifestyle intervention
Keywords: weight loss, lifestyle, diet, exercise, randomized controlled trial
Medical subject headings: Obesity, Sleep Apnea, Obstructive, Weight Loss, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lifestyle interventionBehavioural
Intervention Arm: Usual Care plus a lifestyle behavior change intervention aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention 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.

Study groups in NCT05104450
Study group	Role	What they receive
lifestyle intervention	Experimental	The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care. Receives: Behavioral: lifestyle intervention
usual care control	No intervention	Participants in this arm will continue with usual care without the lifestyle intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Sleep-related Quality of Life
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.
Measured: baseline to 12 months post randomization
Change in Weight
The investigators will compare change in weights between intervention and control using clinic weights from VA medical record
Measured: baseline to between 9 and 15 months post randomization

Secondary outcomes (26)

Cardiovascular Risk Scores
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 1, the maximum is 30%, and a higher value indicates greater risk of cardiovascular disease (worse outcome).
Measured: baseline to 12 months post randomization
PROMIS - Sleep Disturbance Survey Change
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).
Measured: baseline to 3 months post randomization
PROMIS - Sleep Related Impairment Survey Change
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).
Measured: baseline to 3 months post randomization
Systolic Blood Pressure From VA Medical Record
The investigators will compare change in systolic blood pressure values between intervention and control.
Measured: baseline to 12 months post randomization
Treatment Usage Per Day
The investigators will compare change in daily OSA treatment usage between groups using self-report.
Measured: baseline to 3 months post randomization
Apnea Hypopnea Index 1b Criteria
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.
Measured: 12 months post randomization
Longer-term Change in Weight
The investigators will compare longer-term change in weight between intervention and control using clinic weights from VA medical record
Measured: baseline to between 18 and 24 months post randomization
Short-term Change in Sleep-related Quality of Life
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.
Measured: baseline to 3 months post randomization
Longer-term Change in Sleep-related Quality of Life
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.
Measured: baseline to 21 months post randomization
Global Rating of Change
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".
Measured: 3 months post randomization
Change in Self-reported Well-being
The investigators will compare change in self-reported well-being between groups. Participants will complete a 3-item Well-being signs (WBS) survey asking them to rate the proportion of time they are satisfied, involved, and functioning their best in activities that they value. The minimum value is 0% and the maximum value is 100%, and a higher value on WBS indicates a better outcome.
Measured: baseline to 3 months post randomization
Cardiovascular Risk Scores
The investigators will compare cardiovascular risk scores between intervention and control using the non-laboratory Framingham algorithm. The minimum value in this risk score is 1, the maximum is 30%, and a higher value indicates greater risk of cardiovascular disease (worse outcome).
Measured: baseline to 21 months post randomization
PROMIS - Sleep Disturbance Survey Change
The investigators will compare sleep-related 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).
Measured: baseline to 12 months post randomization
PROMIS - Sleep Disturbance Survey Change
The investigators will compare sleep-related 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).
Measured: baseline to 21 months post randomization
PROMIS - Sleep Related Impairment Survey Change
The investigators will compare 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).
Measured: baseline to 12 months post randomization
PROMIS - Sleep Related Impairment Survey Change
The investigators will compare 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).
Measured: baseline to 21 months post randomization
Systolic Blood Pressure From VA Medical Record
The investigators will compare change in systolic blood pressure values between intervention and control.
Measured: baseline to 21 months post randomization
Diastolic Blood Pressure From VA Medical Record
The investigators will compare change in diastolic blood pressure values between intervention and control.
Measured: baseline to 12 months post randomization
Diastolic Blood Pressure From VA Medical Record
The investigators will compare change in diastolic blood pressure values between intervention and control.
Measured: baseline to 21 months post randomization
Treatment Usage Per Day
The investigators will compare change in daily OSA treatment usage between groups using self-report.
Measured: baseline to 12 months post randomization
Treatment Usage Per Day
The investigators will compare change in daily OSA treatment usage between groups using self-report.
Measured: baseline to 21 months post randomization
Global Rating of Change
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".
Measured: 12 months post randomization
Global Rating of Change
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".
Measured: 21 months post randomization
Change in Self-reported Well-being
The investigators will compare change in self-reported well-being between groups. Participants will complete a 3-item Well-being signs (WBS) survey asking them to rate the proportion of time they are satisfied, involved, and functioning their best in activities that they value. The minimum value is 0% and the maximum value is 100%, and a higher value on WBS indicates a better outcome.
Measured: baseline to 12 months post randomization
Change in Self-reported Well-being
The investigators will compare change in self-reported well-being between groups. Participants will complete a 3-item Well-being signs (WBS) survey asking them to rate the proportion of time they are satisfied, involved, and functioning their best in activities that they value. The minimum value is 0% and the maximum value is 100%, and a higher value on WBS indicates a better outcome.
Measured: baseline to 21 months post randomization
Apnea Hypopnea Index 1a Criteria
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 1A criteria of the American Academy of Sleep Medicine.
Measured: 12 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 20221 May 2025

First posted3 Nov 2021
Study start4 Apr 2022
Primary completion1 Aug 2024
Study completion1 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The investigators will randomly assign participants to one of two groups.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 696 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05104450
Sponsor's protocol ID: IIR 20-240
Other IDs: I01HX003319
Acronym: POWER
Status last verified: May 2026
First submitted: 19 Oct 2021
Last updated: 12 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Leonhard AG, Donovan LM. First Steps Toward Implementing Primary Care Obstructive Sleep Apnea Management in Rural West Virginia. Ann Am Thorac Soc. 2025 Jul;22(7):982-983. doi: 10.1513/AnnalsATS.202505-496ED. No abstract available.
PubMed 40590657
Donovan LM, McDowell JA, Maskey P, Josey K, Bais AF, Plumley R, Dashtestani K, Leonhard AG, Wai TH, Pannick AP, Pai J, Zeliadt SB, Hoerster KD, Ma J, Au DH. Pragmatic trial of a self-directed intervention for weight loss in obstructive sleep apnea (POWER). Am J Respir Crit Care Med. 2026 Oct 30:aamag574. doi: 10.1093/ajrccm/aamag574. Online ahead of print.
PubMed 42960868

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach (POWER)
ClinicalTrials.gov ID: NCT05104450
Acronym / sponsor ID: POWER / IIR 20-240
Conditions: Obesity, Sleep Apnea, Obstructive
Keywords: weight loss, lifestyle, diet, exercise, randomized controlled trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 696 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 4 Apr 2022 (actual)
Primary completion: 1 Aug 2024 (actual)
Study completion: 1 May 2025 (actual)
First posted: 3 Nov 2021 (actual)
Results: Posted 21 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objective(s) and Hypotheses: The investigators' primary aim is to test the effectiveness of a proactively delivered and pragmatic weight loss intervention to improve co-primary endpoints of sleep-related quality of life and weight among Veterans with obstructive sleep apnea (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. The investigators will also conduct an implementation process evaluation informed by the RE-AIM framework to identify predictors and determinants of population uptake of the intervention.
Research Design: The investigators plan a hybrid type 1 pragmatic randomized controlled trial assessing effectiveness and an implementation process evaluation.
Methodology The investigators will proactively identify patients with OSA and obesity nationwide in VA using data from the CDW (n=696), randomizing patients 1:1 to usual care plus the lifestyle-based weight loss intervention or usual care alone. The investigators will collect primary outcomes at 12 months, but will also collect outcomes at 3 and up to 21 months to assess trends over time.
Findings/Progress to Date:

Recruitment and outcome collection completed, analysis is ongoing and not yet complete.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: The investigators will randomly assign participants to one of two groups.

Arm	Type	Receives
lifestyle intervention	Experimental	Behavioral: lifestyle interventionThe investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.
usual care control	No intervention	–Participants in this arm will continue with usual care without the lifestyle intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of obstructive sleep apnea (OSA) on sleep study (sleep provider confirmed)
Recent body mass index between 30.0-44.9 kg/m2 and at least one additional plausible BMI in last 12 months
Access to DVD player, computer, and/or internet
Able to participate fully in all study protocol/procedures including informed consent

Key exclusion criteria (7 listed)

Inability to speak, read, or understand English
Recent or active weight loss interventions including use of prescription weight-loss medications, participation in group or individual weight loss programs provided by trained personnel, and prior bariatric surgery or plans for bariatric surgery during the study period.
Expected weight loss because of alternate explanations such as from illness
High variability in weight due to fluctuations in volume status (e.g. ascites - liver disease, chronic heart failure)
Safety and/or adherence concerns due to severe physical or mental health issues, or life expectancy <24 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lifestyle interventionIntervention Arm: Usual Care plus a lifestyle behavior change intervention aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention 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.	Behavioural	lifestyle intervention

Primary outcome

Change in Sleep-related Quality of Life
Time frame: baseline to 12 months post randomization
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.
Change in Weight
Time frame: baseline to between 9 and 15 months post randomization
The investigators will compare change in weights between intervention and control using clinic weights from VA medical record

26 secondary outcomes

Cardiovascular Risk Scores
Time frame: baseline to 12 months post randomization
PROMIS - Sleep Disturbance Survey Change
Time frame: baseline to 3 months post randomization
PROMIS - Sleep Related Impairment Survey Change
Time frame: baseline to 3 months post randomization
Systolic Blood Pressure From VA Medical Record
Time frame: baseline to 12 months post randomization
Treatment Usage Per Day
Time frame: baseline to 3 months post randomization
Apnea Hypopnea Index 1b Criteria
Time frame: 12 months post randomization
Longer-term Change in Weight
Time frame: baseline to between 18 and 24 months post randomization
Short-term Change in Sleep-related Quality of Life
Time frame: baseline to 3 months post randomization
Longer-term Change in Sleep-related Quality of Life
Time frame: baseline to 21 months post randomization
Global Rating of Change
Time frame: 3 months post randomization
Change in Self-reported Well-being
Time frame: baseline to 3 months post randomization
Cardiovascular Risk Scores
Time frame: baseline to 21 months post randomization
PROMIS - Sleep Disturbance Survey Change
Time frame: baseline to 12 months post randomization
PROMIS - Sleep Disturbance Survey Change
Time frame: baseline to 21 months post randomization
PROMIS - Sleep Related Impairment Survey Change
Time frame: baseline to 12 months post randomization
PROMIS - Sleep Related Impairment Survey Change
Time frame: baseline to 21 months post randomization
Systolic Blood Pressure From VA Medical Record
Time frame: baseline to 21 months post randomization
Diastolic Blood Pressure From VA Medical Record
Time frame: baseline to 12 months post randomization
Diastolic Blood Pressure From VA Medical Record
Time frame: baseline to 21 months post randomization
Treatment Usage Per Day
Time frame: baseline to 12 months post randomization
Treatment Usage Per Day
Time frame: baseline to 21 months post randomization
Global Rating of Change
Time frame: 12 months post randomization
Global Rating of Change
Time frame: 21 months post randomization
Change in Self-reported Well-being
Time frame: baseline to 12 months post randomization
Change in Self-reported Well-being
Time frame: baseline to 21 months post randomization
Apnea Hypopnea Index 1a Criteria
Time frame: 12 months post randomization

Results and safety

Results posted to the registry on 21 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lifestyle Intervention	348	344
Usual Care Control	348	345

Primary outcome: Change in Sleep-related Quality of Life

Time frame: baseline to 12 months post randomization. Mean (Standard Deviation). Unit: units on a scale

Measure	Lifestyle Intervention n = 272	Usual Care Control n = 315
Value	1.43 (2.73)	0.93 (2.89)

Lifestyle Intervention vs Usual Care Control: Mean Difference (Net): 0.64 (95% CI 0.25 to 1.04), p = 0.001, Mixed Models Analysis

Population analysed: The investigators report here the unadjusted mean changes between baseline and 12 month follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 12 month follow-up; see Statistical Analysis 1 for those results.

Primary outcome: Change in Weight

Time frame: baseline to between 9 and 15 months post randomization. Mean (Standard Deviation). Unit: kg

Measure	Lifestyle Intervention n = 285	Usual Care Control n = 291
Value	-2.10 (6.75)	-0.88 (5.86)

Lifestyle Intervention vs Usual Care Control: Mean Difference (Net): -1.06 (95% CI -2.05 to -0.06), p = 0.037, Mixed Models Analysis

Population analysed: The investigators report here the unadjusted mean changes between baseline and 9-to-15 month post-randomization follow-up. The analysis population for adjusted between-group differences includes participants with a measurement at baseline and/or 9-to-15 month follow-up; see Statistical Analysis 1 for those results.

26 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lifestyle Intervention	54 of 348 (15.5%)	126 of 348 (36.2%)	1 of 348
Usual Care Control	40 of 348 (11.5%)	127 of 348 (36.5%)	2 of 348

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 40590657Leonhard AG, Donovan LM. First Steps Toward Implementing Primary Care Obstructive Sleep Apnea Management in Rural West Virginia. Ann Am Thorac Soc. 2025 Jul;22(7):982-983. doi: 10.1513/AnnalsATS.202505-496ED. No abstract available.
Derived from this study: PubMed 42960868Donovan LM, McDowell JA, Maskey P, Josey K, Bais AF, Plumley R, Dashtestani K, Leonhard AG, Wai TH, Pannick AP, Pai J, Zeliadt SB, Hoerster KD, Ma J, Au DH. Pragmatic trial of a self-directed intervention for weight loss in obstructive sleep apnea (POWER). Am J Respir Crit Care Med. 2026 Oct 30:aamag574. doi: 10.1093/ajrccm/aamag574. Online ahead of print.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lucas M Donovan, MD MS principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing lifestyle intervention in people with Obesity and Sleep Apnea, Obstructive, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sleep-related Quality of Life (time frame: baseline to 12 months post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05104450, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.