Behavioral Optimization to Overcome Obstructive Sleep Apnea Treatment Barriers
Sleep Apnea
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 50 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 128 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
Previous studies have shown that programs encouraging the use of OSA treatments can help patients use these treatments more often, but the improvement is usually modest. This trial will test if giving patients a decision-making tool when they are first diagnosed with OSA, and combining their responses from this tool into a supportive program, will improve sleep quality and help them use their treatment more regularly.
Read the full description
Background and Significance:
Obstructive Sleep Apnea (OSA) is a significant health issue for many middle-aged and older Veterans. This condition can lead to daytime sleepiness and poor sleep quality and is a risk factor for more serious conditions such as cardiovascular disease, cognitive decline, and even increased risk of death. Common treatments for OSA include the use of medical devices such as positive airway pressure machines or oral appliances. However, many Veterans find these devices uncomfortable or difficult to use regularly. This clinical trial aims to test a new 4 session program to help Veterans stick to their OSA treatment plans using a more person-centered approach.
Innovation and Impact:
This innovative, person-centered approach is integral to the VA's "age-friendly" healthcare transformation. By focusing on what matters most to older Veterans, the investigators aim to enhance their compliance with, and the effectiveness of, OSA therapy. Aligning OSA treatment decisions with each Veteran's health priorities is expected to improve their overall wellbeing and make OSA treatments more effective.
Specific Aims:
1. Improve Sleep Quality: To determine if the new program improves patient-reported outcomes, specifically sleep quality.
2. Enhance Therapy Adherence: To evaluate if the new program increases acceptance and adherence to OSA device therapy.
3. Align Treatment with Priorities: To assess the impact of the program on ensuring that treatment decisions align with each patient's health priorities and values.
Methodology: The investigators will conduct a 5-year multi-site randomized controlled trial with a total of 128 Veterans across sites, aged 50 and older who have been newly diagnosed with OSA. Participants will be randomly assigned to either the new program or an active-control program (both programs include 1 self-directed session and 3 sessions delivered by sleep providers) that incorporate behavioral adherence strategies currently used in the investigators sleep centers. The research team will measure the outcomes 6 months after the program ends.
Path to Translation/Implementation:
The long-term goal of this work is to improve sleep quality and use of prescribed OSA therapies among middle-aged and older Veterans with OSA. If successful, the investigators will implement the intervention at the investigators' institutions and conduct a future type 2 hybrid design trial to test both the effectiveness of the program and its potential for wider implementation.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- referred for an overnight diagnostic sleep test to evaluate for sleep-disordered breathing during the study period
- currently untreated for obstructive sleep apnea (not prescribed therapy in the past year)
Exclusion Criteria:
- referral for overnight sleep test is for another reason than to diagnosis sleep-disordered breathing
- unable to read printed material (e.g., magazine) in English language
- unable to write
- unstable medical/psychiatric illness (e.g., recent hospitalization)
- Telephone Mini-Mental State Examination (MMSE) \< 21 or diagnosis of dementia
- unstable housing
- unable to attend study video or in-person visits
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Double masked
Sleep education program X + Y
Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy. Tests behavioral strategy program X plus Y.
Behavioral: Behavioral strategy program X plus Y
Sleep education program X
Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy Tests behavioral strategy X.
Behavioral: Behavioral strategy program X
Behavioral strategy program X plus Y BEHAVIORAL
Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy. Tests behavioral strategy program X plus Y.
Behavioral strategy program X BEHAVIORAL
Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy Tests behavioral strategy X.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.
The PSQI total score will be used as a measurement of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
Secondary measures
Acceptance of therapy
Time frame: One week after the end of the intervention/control sessions, which is approximately 2 months after randomization.
Percentage of participants prescribed device therapy with \> 0 days of use in the 30 days prior to the 6-month follow-up timepoint.
Treatment adherence by machine report
Time frame: 6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.
Percentage of days of machine reported use \>= 4 hours in the prior 30 days.
Other measures
Decisional Conflict Scale - 1 item
Time frame: End of session 1, which is within 7 days of randomization.
Decisional Conflict Scale "What's important" item. This item is scored as 0 (best) to 4 (worst).
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (2)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
2 locations
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los Angeles, California, United StatesStatus unknown
John D. Dingell VA Medical Center, Detroit, MIDetroit, Michigan, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- VA Office of Research and Development
- Study start
- Jan 4, 2027 Estimated
- Primary completion
- Sep 30, 2030 Estimated
- Study completion
- Mar 31, 2031 Estimated
- First posted
- Oct 6, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Helping Veterans With Obstructive Sleep Apnea Determine What Matters Most in Choosing a Treatment Option: a Randomized Trial
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026