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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
REST pilot Trial 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.Check my eligibility
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.See study design
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.
REST pilot Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean number of hours used on average over the last 30 days
Secondary outcome measures
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 moreREST pilot 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
2019
N/A
~2140
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,455 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received treatment at the San Francisco General Hospital Sleep Clinic.You have used a special device to help with sleep apnea in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Health coaching arm
- Group 2: Usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applicants still being accepted into the experiment?
"Affirmative. According to clinicaltrials.gov, this research trial has been open since November 18th 2020 and is actively recruiting potential participants. 100 volunteers are needed from one site for the study's duration."
Answered by AI
To what extent are participants enrolled in this investigation?
"Affirmative. According to the clinicaltrials.gov website, the trial is still open and seeking enrollees. It was originally posted on November 18th 2020 with its latest update occurring May 23rd 2022. This research seeks 100 participants from a single site."
Answered by AI
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