Reaching for Equity in Sleep Apnea Treatment (REST) Study

NCT04209985 | Completed

• 1 other identifier: 19-27249
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test a brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of obstructive sleep apnea.

Conditions

Sleep Apnea

Keywords

Health coaching; Adherence to treatment; Health disparities

Outcome Measures

Primary Outcomes (1)

• Mean number of hours used on average over the last 30 days

  Total number of hours PAP device used during 30 day period divided by 30 days (PAP device is part of existing clinical care)

  Enrollment to 4 months post enrollment

Secondary Outcomes (6)

• Proportion using device at any time in last 30 days

  Enrollment to 4 months post enrollment

• Patient-reported daytime sleepiness

  Enrollment to 4 months post enrollment

• Attitudes to PAP treatment

  Enrollment to 4 months post enrollment

• Confidence in using PAP therapy

  Enrollment to 4 months post enrollment

• Mean number of hours used on average over the last 30 days on nights that device was used

  Enrollment to 4 months post enrollment

Study Arms (2)

Health coaching arm

EXPERIMENTAL

For the health coaching arm, an unlicensed, trained health coach will call patients up to five times to identify and resolve barriers to adherence, including lack of understanding of their condition or the treatment, discomfort in acclimating to treatment, technical difficulties in mask fit or device settings, and challenges in navigating durable medical equipment providers.

Behavioral: Health coaching

Usual care

NO INTERVENTION

Patients assigned to usual care have access to all other available resources, including technical support from durable medical equipment providers, respiratory therapist visits with the Sleep Clinic, group visits, or visits with their primary care provider.

Interventions

Health coaching BEHAVIORAL

Brief telephonic intervention consisting of up to five phone calls from a health coach

Health coaching arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English- or Spanish-speaking
• At least 18 years of age
• Had previously received a modem-enabled positive airway pressure device for the treatment of sleep apnea
• Not currently meeting Medicare standards for adherence of at least 4 hours per night for at least 70% of the last 30 nights
• Received care from the San Francisco General Hospital Sleep Clinic

You may not qualify if:

• Not English- or Spanish-speaking
• Younger than 18 years
• Does not have phone number at which could be reached

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital Sleep Clinic

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Health Behavior; Behavior

Study Officials

• Rachel Willard-Grace, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomly assigned to receive health coaching or usual care. Patients assigned to usual care have access to all existing resources, including technical support from durable medical equipment providers, respiratory therapist visits with the Sleep Clinic, group visits, or visits with their primary care provider. Patients in the health coaching arm have access to all usual care resources. In addition, they will be assigned an unlicensed, trained health coach who will call them up to five times to identify and resolve barriers to adherence, including lack of understanding of their condition or the treatment, discomfort in acclimating to treatment, technical difficulties in mask fit or device settings, and challenges in navigating durable medical equipment providers.

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 24, 2019
• Study Start: November 18, 2020
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)