NCT07207473

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
56mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2030

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

September 26, 2025

Last Update Submit

April 20, 2026

Conditions

Sleep Apnea

Keywords

sleep apneadecision making, sharedhealth priorities

Outcome Measures

Primary Outcomes (1)

  • 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.

    6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.

Secondary Outcomes (2)

  • Acceptance of therapy

    One week after the end of the intervention/control sessions, which is approximately 2 months after randomization.

  • Treatment adherence by machine report

    6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.

Other Outcomes (1)

  • Decisional Conflict Scale - 1 item

    End of session 1, which is within 7 days of randomization.

Study Arms (2)

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.

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.

Behavioral: Behavioral strategy program X

Interventions

Behavioral strategy program X plus YBEHAVIORAL

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 + Y
Behavioral strategy program XBEHAVIORAL

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

Sleep education program X

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

West Los Angeles, California, 90073-1003, United States

Location

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201-1916, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Constance H Fung, MD MSHS

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin E Der-mcleod

CONTACT

(818) 891-7711erin.der-mcleod@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors will be blinded to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2025

First Posted

October 6, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)