Sleep ApneaBOOSTNCT07207473
Behavioral Optimization to Overcome Obstructive Sleep Apnea Treatment Barriers
A study testing Behavioral strategy program X plus Y and Behavioral strategy program X in people with Sleep Apnea, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Behavioral strategy program X plus Y and Behavioral strategy program X
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2026to 31 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- referred for an overnight diagnostic sleep test to evaluate for sleep-disordered breathing during the study period
- currently untreated for OSA (not prescribed therapy in the past year)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201-1916
M. Safwan Badr, MD, 313-576-1000 ext. 65710, M.Badr@va.gov
Susmita Chowdhuri, MD, 3135761000 ext. 64451, Susmita.Chowdhuri@va.gov
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
Constance H Fung, MD MSHS, (818) 891-7711 ext. 36075, Constance.Fung@va.gov
Constance H Fung, MD MSHS
About this study
Official title: Helping Veterans With Obstructive Sleep Apnea Determine What Matters Most in Choosing a Treatment Option: a Randomized Trial
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 detailed 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:
- Improve Sleep Quality: To determine if the new program improves patient-reported outcomes, specifically sleep quality.
- Enhance Therapy Adherence: To evaluate if the new program increases acceptance and adherence to OSA device therapy.
- 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.
- Conditions
- Sleep Apnea
- Being tested
- Behavioral strategy program X plus Y, Behavioral strategy program X
- Keywords
- sleep apnea, decision making, shared, health priorities
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral strategy program X plus YBehavioural
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 XBehavioural
Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy Tests behavioral strategy X.
| Study group | Role | What they receive |
|---|---|---|
| Sleep education program X + Y | Experimental | 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. Receives: Behavioral: Behavioral strategy program X plus Y |
| Sleep education program X | Active comparator | Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy Tests behavioral strategy X. Receives: Behavioral: Behavioral strategy program X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI total score will be used as a measurement of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
Measured: 6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.
Secondary outcomes (2)
Acceptance of therapy
Percentage of participants prescribed device therapy with > 0 days of use in the 30 days prior to the 6-month follow-up timepoint.
Measured: One week after the end of the intervention/control sessions, which is approximately 2 months after randomization.
Treatment adherence by machine report
Percentage of days of machine reported use >= 4 hours in the prior 30 days.
Measured: 6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start2 Nov 2026 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Constance H Fung, MD MSHS, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207473
- Sponsor's protocol ID
- PULM-005-25S
- Acronym
- BOOST
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Veterans With Obstructive Sleep Apnea Determine What Matters Most in Choosing a Treatment Option: a Randomized Trial
- ClinicalTrials.gov ID
- NCT07207473
- Acronym / sponsor ID
- BOOST / PULM-005-25S
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea, decision making, shared, health priorities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Improve Sleep Quality: To determine if the new program improves patient-reported outcomes, specifically sleep quality.
- Enhance Therapy Adherence: To evaluate if the new program increases acceptance and adherence to OSA device therapy.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep education program X + Y | Experimental | Behavioral: Behavioral strategy program X plus YBrief 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. |
| Sleep education program X | Active comparator | Behavioral: Behavioral strategy program XBrief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy Tests behavioral strategy X. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- referred for an overnight diagnostic sleep test to evaluate for sleep-disordered breathing during the study period
- currently untreated for OSA (not prescribed therapy in the past year)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Behavioral strategy program X plus YBrief 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. | Behavioural | Sleep education program X + Y |
| Behavioral strategy program XBrief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy Tests behavioral strategy X. | Behavioural | Sleep education program X |
Primary outcome
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.
2 secondary outcomes
Acceptance of therapy
Time frame: One week after the end of the intervention/control sessions, which is approximately 2 months after randomization.
Treatment adherence by machine report
Time frame: 6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
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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.
Constance H Fung, MD MSHS principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral strategy program X plus Y and Behavioral strategy program X in people with Sleep Apnea, run by VA Office of Research and Development at 2 sites 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 2 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: opening soon, as of the sponsor's last update on 5 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 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin E Der-mcleod ((818) 891-7711, erin.der-mcleod@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: 6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2026.