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OpenTrials
Completed

NCT Number: NCT05419323

Direct Referral for Apnea Monitoring

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Francisco VA Medical Center, San Francisco, CA, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time from referral

    Time frame: 1 year

    For Arms 1 & 2: Compare time from referral to sleep testing and treatment of OSA

  2. PAP adherence

    Time frame: 1 year

    For Arms 1 & 2: PAP treatment adherence (for example, Percentage of days with usage >= 4 hours) between Traditional and DREAM clinical pathways

  3. AHI scores

    Time frame: 4 years

    For Arm 3: Compare apnea-hypopnea index (AHI) scores between HSAT and PSG procedures

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • San Francisco Veterans Affairs Medical Center

Registry information

Official study title

Improving Access to Sleep Apnea Care: A Pragmatic Study of New Consultation Models

Acronym: DREAM

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2022
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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