Direct Referral for Apnea Monitoring

Recruiting

• Conditions: Obstructive Sleep Apnea (OSA)

• Registration Number: NCT05419323
• Lead Sponsor: VA Office of Research and Development

Brief Summary

The primary objective of this project is to compare a health care delivery model, Direct Referral for Apnea Monitoring (DREAM), with initial in-person (Traditional) clinic appointments for Veterans at risk for obstructive sleep apnea (OSA). A secondary objective is to determine the negative predictive value (NPV) of home sleep apnea testing (HSAT).

Detailed Description

Patients referred to one of 3 participating VA sleep medicine clinics (San Francisco VA, VA Portland or VA Pittsburgh) for OSA will be assigned either to the Traditional clinical pathway (which might include an initial encounter with a sleep care provider through in-person visits, telephone clinics, or video conferencing) or the DREAM pathway which will omit the initial encounter with a care provider. After a clinician conducts a chart review of medical records, patients in the DREAM pathway will be referred for sleep testing. All patients will be tracked from the time of referral until 90-days past the initiation of treatment. To determine the NPV of HSAT, results of sleep tests will be compared for patients who undergo both HSAT and polysomnographic (PSG) procedures. Concurrent PSG and HSAT studies will be done at Portland, Pittsburgh, and San Francisco.

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2413

Inclusion Criteria

Age 18 years Agrees to be seen by a VA sleep program Reason for referral to sleep clinic: New OSA Evaluation

Exclusion Criteria

Age < 18 years Declines to be seen by a VA sleep program Reason for referral to sleep clinic: anything other than a new OSA evaluation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time from referral	1 year	For Arms 1 \& 2: Compare time from referral to sleep testing and treatment of OSA
AHI scores	4 years	For Arm 3: Compare apnea-hypopnea index (AHI) scores between HSAT and PSG procedures
PAP adherence	1 year	For Arms 1 \& 2: PAP treatment adherence (for example, Percentage of days with usage \>= 4 hours) between Traditional and DREAM clinical pathways

Trial Locations

Locations (3)

San Francisco VA Medical Center, San Francisco, CA; 🇺🇸 San Francisco, California, United States

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA; 🇺🇸 Pittsburgh, Pennsylvania, United States

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States