← Back to Search

Health Coaching for Sleep Apnea (REST pilot Trial)

N/A

Recruiting

Led By Rachel Willard-Grace, MPH

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment to 4 months post enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a short phone call from a health coach can help people with sleep apnea stick to their positive airway pressure (PAP) therapy.

Who is the study for?

The REST study is for English or Spanish speakers over 18 who have sleep apnea and got a modem-enabled airway pressure device from San Francisco General Hospital Sleep Clinic but aren't using it enough (less than Medicare's standard). They need to be reachable by phone.

What is being tested?

This trial tests if a short health coaching program done over the phone can help people with obstructive sleep apnea stick to their positive airway pressure therapy better.

What are the potential side effects?

Since this trial involves telephonic health coaching, there are no direct medical side effects. However, participants may experience changes in sleep patterns due to improved adherence to therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment to 4 months post enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment to 4 months post enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to 4 months post enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Attitudes to PAP treatment

Confidence in using PAP therapy

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

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Health coaching armExperimental Treatment1 Intervention

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.

Group II: Usual careActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Health coaching

2021

Completed Phase 3

~2230

Do I qualify?Apply below to find out