Skip to main content
OpenTrials
Completed

NCT Number: NCT04209985

Reaching for Equity in Sleep Apnea Treatment (REST) Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Apnea Apnea Behavior Dyssomnias Health Behavior Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuckerberg San Francisco General Hospital Sleep Clinic

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Health Coaching

Behavioral

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

Primary outcomes

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

    Time frame: Enrollment to 4 months post enrollment

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

Secondary outcomes

  1. Proportion using device at any time in last 30 days

    Time frame: Enrollment to 4 months post enrollment

    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)

  2. Patient-reported daytime sleepiness

    Time frame: Enrollment to 4 months post enrollment

    Mean score on the Epworth Sleepiness Scale (8 items with aggregate scale of 0-24 points, where 24 indicates greatest sleepiness symptoms)

  3. Attitudes to PAP treatment

    Time frame: Enrollment to 4 months post enrollment

    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)

  4. Confidence in using PAP therapy

    Time frame: Enrollment to 4 months post enrollment

    Mean score on self-efficacy for use of PAP therapy (4 items, with combined scale from 0-40, where 40 indicates greatest self-efficacy)

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

    Time frame: Enrollment to 4 months post enrollment

    Total number of hours device used during 30 day period divided by the number of days on which the device was used

  6. Mean proportion of last 30 days in which device used at least 4 hours/night

    Time frame: Enrollment to 4 months post enrollment

    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)

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: REST pilot

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 24, 2019
Registry last updated
Apr 28, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.