Sleep ApneaREST pilotNCT04209985
Reaching for Equity in Sleep Apnea Treatment (REST) Study
A study testing Health coaching in people with Sleep Apnea, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2020to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not English- or Spanish-speaking
- Younger than 18 years
- Does not have phone number at which could be reached
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General Hospital Sleep Clinic
San Francisco, California, 94110
About this study
Official title: Reaching for Equity in Sleep Apnea Treatment (REST): Pilot of Telephonic Health Coaching Intervention to Improve Adherence to Sleep Apnea Treatment
This study will test a brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of obstructive sleep apnea.
Read the detailed 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.
- Conditions
- Sleep Apnea
- Being tested
- Health coaching
- Keywords
- Health coaching, Adherence to treatment, Health disparities
- Medical subject headings
- Sleep Apnea Syndromes, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health coachingBehavioural
Brief telephonic intervention consisting of up to five phone calls from a health coach
| Study group | Role | What they receive |
|---|---|---|
| Health coaching arm | Experimental | 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. Receives: Behavioral: Health coaching |
| Usual care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Enrollment to 4 months post enrollment
Secondary outcomes (6)
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)
Measured: Enrollment to 4 months post enrollment
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)
Measured: Enrollment to 4 months post enrollment
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)
Measured: Enrollment to 4 months post enrollment
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)
Measured: Enrollment to 4 months post enrollment
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
Measured: Enrollment to 4 months post enrollment
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)
Measured: Enrollment to 4 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start18 Nov 2020
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomly assigned to receive health coaching or usual care. Patients assigned to usual care have access to all existing 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. Patients in the health coaching arm have access to all usual care resources. In addition, they will be assigned an unlicensed, trained health coach who will call them 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.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Willard-Grace, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209985
- Sponsor's protocol ID
- 19-27249
- Acronym
- REST pilot
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2019
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching for Equity in Sleep Apnea Treatment (REST): Pilot of Telephonic Health Coaching Intervention to Improve Adherence to Sleep Apnea Treatment
- ClinicalTrials.gov ID
- NCT04209985
- Acronym / sponsor ID
- REST pilot / 19-27249
- Conditions
- Sleep Apnea
- Keywords
- Health coaching, Adherence to treatment, Health disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test a brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of obstructive sleep apnea.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomly assigned to receive health coaching or usual care. Patients assigned to usual care have access to all existing 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. Patients in the health coaching arm have access to all usual care resources. In addition, they will be assigned an unlicensed, trained health coach who will call them 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.
| Arm | Type | Receives |
|---|---|---|
| Health coaching arm | Experimental | Behavioral: Health coachingFor 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. |
| Usual care | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Not English- or Spanish-speaking
- Younger than 18 years
- Does not have phone number at which could be reached
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health coachingBrief telephonic intervention consisting of up to five phone calls from a health coach | Behavioural | Health coaching arm |
Primary outcome
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)
6 secondary outcomes
Proportion using device at any time in last 30 days
Time frame: Enrollment to 4 months post enrollment
Patient-reported daytime sleepiness
Time frame: Enrollment to 4 months post enrollment
Attitudes to PAP treatment
Time frame: Enrollment to 4 months post enrollment
Confidence in using PAP therapy
Time frame: Enrollment to 4 months post enrollment
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
Mean proportion of last 30 days in which device used at least 4 hours/night
Time frame: Enrollment to 4 months post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Willard-Grace, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health coaching in people with Sleep Apnea, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of hours used on average over the last 30 days (time frame: Enrollment to 4 months post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 2 Nov 2026.