Behavioral Optimization to Overcome Obstructive Sleep Apnea Treatment Barriers

NCT ID: NCT07207473

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-01
• Study Completion Date: 2030-12-31

Brief 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 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:

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.

Conditions

Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Behavioral strategy program X plus Y

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Behavioral strategy program X

Intervention Type: BEHAVIORAL

Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy Tests behavioral strategy X.

Interventions

Behavioral strategy program X plus 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.

Intervention Type: BEHAVIORAL

Behavioral strategy 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Constance H Fung, MD MSHS

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Locations

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, United States

Countries

United States

Central Contacts

Constance H Fung, MD MSHS

Role: CONTACT

Constance.Fung@va.gov

(818) 891-7711 ext. 36075

Erin E Der-mcleod

Role: CONTACT

erin.der-mcleod@va.gov

(818) 891-7711

Facility Contacts

Michael K Ong, MD PhD

Role: primary

Michael.Ong2@va.gov

310-478-3711 ext. 42345

Scott E Krahl, PhD MA BA

Role: backup

scott.krahl@va.gov

(818) 895-5861

M. Safwan Badr, MD

Role: primary

M.Badr@va.gov

313-576-1000 ext. 65710

Susmita Chowdhuri, MD

Role: backup

Susmita.Chowdhuri@va.gov

313-576-1000 ext. 64451

Other Identifiers

PULM-005-25S

Identifier Type: -

Identifier Source: org_study_id