Direct Referral for Apnea Monitoring (DREAM)

VA Office of Research and Development

Status: Active, not recruiting

Conditions: Obstructive Sleep Apnea (OSA)

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT05419323

19-27

IIR 15-339

Details and patient eligibility

About

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).

Full 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.

Enrollment: 6,501 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

6,501 participants in 3 patient groups

Traditional clinical pathway for OSA

Description:

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

Description:

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

Description:

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.