Direct Referral for Apnea Monitoring (DREAM)

May 8, 2026 updated by: VA Office of Research and Development

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

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

6501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121-1563
        • San Francisco VA Medical Center, San Francisco, CA
    • Oregon
      • Portland, Oregon, United States, 97207-2964
        • VA Portland Health Care System, Portland, OR
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will include patients referred for new OSA evaluations at Sleep Medicine clinics at the 3 VA study sites. Participants will be identified via a review of their medical records by the PIs (study physicians) after they are referred for OSA evaluations at the 3 study sites.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Traditional clinical pathway for OSA

After referral, patients will have an initial encounter with a sleep care provider which might include in-person visits, telephone clinics, or video conferencing.

Intervention/Treatment: Patients in Arm 1 will receive routine care for OSA at one of the participating VA Sleep Medicine clinics.
DREAM clinical pathway for OSA

After referral, patients will not have an 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.

Intervention/Treatment: Patients in Arm 2 will receive routine care for OSA at one of the participating VA Sleep Medicine clinics.
Negative predictive value of HSAT

Results of sleep tests will be compared for patients who undergo both HSAT and polysomnographic (PSG) procedures.

Intervention/Treatment: Patients in Arm 3 will undergo

a) HSAT sleep testing followed by PSG testing, or b) simultaneous administration of PSG and HSAT sleep testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from referral
Time Frame: 1 year
For Arms 1 & 2: Compare time from referral to sleep testing and treatment of OSA
1 year
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
1 year
AHI scores
Time Frame: 4 years
For Arm 3: Compare apnea-hypopnea index (AHI) scores between HSAT and PSG procedures
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

San Francisco Veterans Affairs Medical Center

Investigators

  • Principal Investigator: Kathleen Fumiko Sarmiento, MD MPH, San Francisco VA Medical Center, San Francisco, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

March 31, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 15-339
  • 19-27 (Other Identifier: San Francisco Veterans Affairs Medical Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared at the conclusion of this study.

IPD Sharing Time Frame

From study initiation to completion, 2020-2025

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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