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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

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 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

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

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,551 Previous Clinical Trials
15,257,786 Total Patients Enrolled
1 Trials studying Sleep Apnea
131 Patients Enrolled for Sleep Apnea
Rachel Willard-Grace, MPHPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
360 Total Patients Enrolled

Media Library

Health coaching Clinical Trial Eligibility Overview. Trial Name: NCT04209985 — N/A
Sleep Apnea Research Study Groups: Health coaching arm, Usual care
Sleep Apnea Clinical Trial 2023: Health coaching Highlights & Side Effects. Trial Name: NCT04209985 — N/A
Health coaching 2023 Treatment Timeline for Medical Study. Trial Name: NCT04209985 — N/A
~6 spots leftby Dec 2024
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