Reaching for Equity in Sleep Apnea Treatment (REST) Study

Sleep Apnea Clinical Trial

— REST pilot  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04209985
• Other study ID #: 19-27249
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: George Su, MD
• Phone: 628-206-8314
• Email: George.Su[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Behavioral:
• Health coaching
Brief telephonic intervention consisting of up to five phone calls from a health coach

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital Sleep Clinic	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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