Reaching for Equity in Sleep Apnea Treatment (REST) Study (REST pilot)

Reaching for Equity in Sleep Apnea Treatment (REST): Pilot of Telephonic Health Coaching Intervention to Improve Adherence to Sleep Apnea Treatment

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

Study Overview

• Status: Completed
• Conditions: Sleep Apnea
• Intervention / Treatment: Behavioral: Health coaching

Detailed Description

The investigators will carry out a pilot study in which patients will be randomly assigned to receive health coaching or usual care. Participants are English- and Spanish-speaking patients from a county-based public health system who have received a positive airway pressure device for the treatment of sleep apnea. An unlicensed, trained health coach will call patients three times to resolve barriers to adherence. Primary outcomes include both adherence measures collected by the device modem at baseline and 4 months, and patient-reported outcomes such as daytime sleepiness.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Zuckerberg San Francisco General Hospital Sleep Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health coaching arm; 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; Brief telephonic intervention consisting of up to five phone calls from a health coach
No Intervention: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion using device at any time in last 30 days	Numerator: Number of people using PAP device at any time in last 30 days; Denominator: Number of people in study arm (PAP device is part of existing clinical care)	Enrollment to 4 months post enrollment
Patient-reported daytime sleepiness	Mean score on the Epworth Sleepiness Scale (8 items with aggregate scale of 0-24 points, where 24 indicates greatest sleepiness symptoms)	Enrollment to 4 months post enrollment
Attitudes to PAP treatment	Mean score on the Attitudes to PAP Treatment Inventory (5 items with combined scale of 4-25, where higher scores indicate negative attitudes toward PAP treatment)	Enrollment to 4 months post enrollment
Confidence in using PAP therapy	Mean score on self-efficacy for use of PAP therapy (4 items, with combined scale from 0-40, where 40 indicates greatest self-efficacy)	Enrollment to 4 months post enrollment
Mean number of hours used on average over the last 30 days on nights that device was used	Total number of hours device used during 30 day period divided by the number of days on which the device was used	Enrollment to 4 months post enrollment
Mean proportion of last 30 days in which device used at least 4 hours/night	Mean across group of: (Numerator: Number of days in last 30 days that PAP device was used at least 4 hours; Denominator: 30 days) (PAP device is part of existing clinical care)	Enrollment to 4 months post enrollment

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Rachel Willard-Grace, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Actual): December 19, 2024
• Study Completion (Actual): December 19, 2024

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Health disparities; Health coaching; Adherence to treatment
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Health Behavior; Sleep Apnea Syndromes; Treatment Adherence and Compliance
• Other Study ID Numbers: 19-27249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No