Health Coaching for Sleep Apnea

(REST pilot Trial)

Overseen By George Su, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-English/Spanish, Under 18, No phone

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 4 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether phone-based health coaching can help people consistently use their sleep apnea treatment, a positive airway pressure (PAP) device. A health coach will call participants to address common issues, such as equipment discomfort or technical problems. Eligible participants have sleep apnea, use a PAP device but not enough at night, and receive care from San Francisco General Hospital Sleep Clinic. As an unphased trial, this study offers participants the opportunity to enhance their treatment adherence through personalized support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that health coaching is safe for improving adherence to sleep apnea treatment?

Research has shown that health coaching can safely help people with obstructive sleep apnea adhere to their treatment. One study found that health coaching improved the use of positive airway pressure (PAP) devices, which are often used to treat sleep apnea. This suggests that health coaching can make it easier for patients to continue using their devices, enhancing treatment effectiveness.

No reports of harmful side effects from the health coaching itself emerged, indicating that patients tolerate it well. Health coaching involves trained coaches assisting patients through phone calls, addressing challenges like understanding the condition, managing discomfort, or resolving device issues. This approach makes the process more supportive and manageable without adding medical risks.

Overall, for those considering joining this trial, evidence suggests that the health coaching component is safe and could aid in maintaining adherence to sleep apnea treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about health coaching for sleep apnea because it offers a personalized approach to improving treatment adherence. Unlike traditional options, such as CPAP machines that require technical proficiency and consistent use, health coaching involves direct interaction with patients to tackle barriers like lack of understanding and technical difficulties. This method aims to enhance patient engagement and comfort, potentially leading to better outcomes by ensuring that patients are more effectively using their prescribed treatments.

What evidence suggests that health coaching is effective for improving adherence to sleep apnea treatment?

Research shows that health coaching, which participants in this trial may receive, helps people consistently use their positive airway pressure (PAP) devices for sleep apnea. One study found that patients who received health coaching increased their PAP machine usage from about 5.1 hours to 6 hours per night after six weeks. Regular use of PAP devices is crucial for managing sleep apnea, leading to better breathing and sleep quality. Health coaching supports patients by helping them understand their condition, manage discomfort, and solve technical problems with the equipment. Overall, evidence suggests that health coaching significantly improves adherence to PAP therapy and enhances health outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Rachel Willard-Grace, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have received treatment at the San Francisco General Hospital Sleep Clinic.

English- or Spanish-speaking

Not currently meeting Medicare standards for adherence of at least 4 hours per night for at least 70% of the last 30 nights

Exclusion Criteria

Not English- or Spanish-speaking

Does not have phone number at which could be reached

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telephonic health coaching to improve adherence to positive airway pressure therapy

4 months

Up to 5 calls (telephonic)

Follow-up

Participants are monitored for adherence and patient-reported outcomes such as daytime sleepiness

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Health coaching

Trial Overview

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.

How Is the Trial Designed?

Group I: Health coaching arm Experimental Treatment 1 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 care Active Control 1 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 Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

In a study of 26 obstructive sleep apnea patients over 20 weeks, Erickson coaching led to significant reductions in body weight, neck circumference, waist-to-hip ratio, and body fat percentage, with an average weight loss of 5.2%.

77% of participants achieved a weight reduction of over 3%, and factors like attending coaching sessions and reaching personal physical performance goals were linked to successful weight loss, highlighting the effectiveness of coaching in promoting healthy lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erickson solution-focused coaching for weight management in obese patients with obstructive sleep apnoea: ECOHEALTH pilot study. Tkacova, R., Paranicova, I., Timkova, E., et al.[2021]

In a study of 40 obese patients with moderate-to-severe obstructive sleep apnoea syndrome (OSAS), the Mediterranean diet (MD) combined with physical activity significantly reduced the apnoea-hypopnoea index (AHI) during REM sleep compared to a prudent diet (PD).

The MD group also experienced a greater reduction in waist circumference and waist-to-height and waist-to-hip ratios, indicating improved body composition, which is beneficial for managing OSAS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Mediterranean diet versus prudent diet combined with physical activity on OSAS: a randomised trial. Papandreou, C., Schiza, SE., Bouloukaki, I., et al.[2022]

Health and wellness coaching (HWC) is emerging as an effective method for promoting lifestyle changes to prevent and treat chronic diseases like diabetes and heart disease, based on a systematic review of 219 articles, 150 of which were data-based.

The review highlights the need for further research to establish consensus on HWC definitions and standards, as the current literature is scattered and lacks a comprehensive summary, making it challenging for practitioners and researchers to access relevant information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compendium of the Health and Wellness Coaching Literature. Sforzo, GA., Kaye, MP., Todorova, I., et al.[2020]

Obstructive sleep apnoea (OSA) is often linked with obesity, affecting about 70% of patients, and while CPAP therapy is the standard treatment, it does not lead to significant long-term weight loss or improvements in cardiovascular health.

The study proposes that Erikson coaching, a lifestyle intervention, could enhance adherence to healthy behaviors in obese OSA patients, potentially leading to weight reduction and better metabolic health, which may ultimately reduce cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erickson health coaching: An innovative approach for weight management in obese patients with obstructive sleep apnoea? Tkacova, R.[2019]

CPAP devices are effective in preventing apnea and improving sleep quality in people with obstructive sleep apnea, but many patients prefer less effective oral appliances due to challenges with CPAP use.

Support groups for CPAP users can significantly enhance motivation, provide practical knowledge, and create a caring community, suggesting that healthcare providers should recommend these groups to improve patient adherence and experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CPAP devices: encouraging patients with sleep apnea. Dickerson, SS., Kennedy, MC.[2022]

Obstructive sleep apnoea (OSA) is common, affecting about 25% of men and 10% of women in the U.S., and can lead to serious health issues like cardiovascular disease, even in those without daytime sleepiness.

Patients with a high likelihood of moderate to severe OSA can be effectively managed in primary care settings using simplified care models, which may improve access to treatment and address lifestyle factors contributing to the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to assess, diagnose, refer and treat adult obstructive sleep apnoea: a commentary on the choices. Mansfield, DR., Antic, NA., McEvoy, RD.[2019]

The Health Coaching Program, tested by 20 family doctors over 12 months, successfully engaged 91% of invited patients, demonstrating high acceptance and feasibility among both patients and physicians.

Of the patients who participated, 37% completed all four steps of the program, and about 50% achieved a positive behavior change, indicating the program's effectiveness in promoting health behavior improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Health counseling in primary care doctors' offices: a new wind! The Health Coaching Program of the Swiss College of Primary Care Medicine]. Neuner-Jehle, S., Grüninger, U., Schmid, M.[2015]

Patient coaching is an effective process that helps individuals achieve their health goals, whether for preventive measures or chronic treatment.

By creating a supportive environment for open communication, coaching can lead to quicker and more efficient improvements in health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Coaching and diabetes]. Roca, JM.[2011]

In a study involving 1535 patients with type 2 diabetes, coronary artery disease, and congestive heart failure, telephone health coaching (THC) did not show a statistically significant effect on reducing mortality and morbidity compared to usual care over an 8-year follow-up period.

However, participants who actively engaged in the health coaching showed potential benefits in secondary analyses, suggesting that THC may be effective for those willing to participate, indicating a need for further research to identify which patients could benefit most from this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eight-year post-trial follow-up of morbidity and mortality of telephone health coaching. Mustonen, E., Hörhammer, I., Patja, K., et al.[2021]

HealtheSteps™ is a lifestyle prescription program that effectively engages participants at risk for chronic diseases through bi-monthly coaching sessions focused on physical activity and healthy eating, showing high acceptability among both coaches and participants.

Participants appreciated the program's accountability features but suggested enhancements like increased feedback from coaches and more resources on healthy eating, indicating areas for improvement without needing major changes to the program's structure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process evaluation of the HealtheSteps™ lifestyle prescription program. Blunt, W., Gill, DP., Riggin, B., et al.[2019]

A 12-month telemonitoring and coaching program significantly improves CPAP adherence over time compared to no support, maintaining higher usage rates at 12 and 18 months.

In contrast, a shorter 3-month support program increases CPAP use initially but does not sustain improvements beyond the support period, highlighting the importance of longer-term interventions for effective treatment of obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an Extended Telemonitoring and Coaching Program on Continuous Positive Airway Pressure Adherence. Patel, SR., Bakker, JP., Stitt, CJ., et al.[2022]

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