Health Coaching for Sleep Apnea

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Coastal Carolina University

Disqualifiers: End stage renal failure, heart failure, stroke, others

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

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding health and wellness coaching to standard CPAP therapy can improve treatment for people with obstructive sleep apnea (OSA), a condition where breathing stops and starts during sleep. It compares two groups: one receiving only CPAP therapy and another receiving CPAP plus coaching on weight management and sleep habits. The researchers aim to determine if the coaching helps people adhere to their CPAP therapy and aids in weight loss. Ideal participants have been recently diagnosed with moderate to severe OSA, use a CPAP machine, and live in Tennessee. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance OSA treatment options.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that integrating health coaching with CPAP therapy is safe?

Research has shown that combining health and wellness coaching (HWC) with wearable devices can help people adhere to their CPAP therapy for sleep apnea. Studies have found that patients using HWC tend to use their CPAP machines more regularly, potentially leading to better treatment outcomes.

In terms of safety, health coaching and wearable devices are generally safe. No strong evidence indicates harm or negative effects from these methods. While wearable devices can track sleep patterns, they do not replace medical check-ups. Therefore, they should not substitute for professional medical advice or treatment.

Overall, combining HWC with CPAP therapy aims to enhance treatment without adding significant safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about health coaching for sleep apnea because it leverages wearable technology to provide personalized, daily insights into sleep patterns. Unlike traditional treatments like CPAP machines, which primarily focus on maintaining airway pressure, this approach combines digital health tools with weekly video coaching sessions to encourage lifestyle changes and improve CPAP adherence. This integrative method not only helps patients understand their sleep data but also offers tailored guidance on sleep habits and nutrition, potentially leading to more sustainable health improvements.

What evidence suggests that health coaching with CPAP therapy is effective for sleep apnea?

This trial will compare the effects of health coaching with wearable devices to a control group receiving no intervention. Research has shown that health coaching combined with wearable devices can help people with obstructive sleep apnea use their CPAP (Continuous Positive Airway Pressure) machines more regularly. Participants receiving health coaching tend to use their CPAP machines more frequently, both in hours per night and days per month. This approach also aids in weight management, which is crucial for controlling sleep apnea. Health coaching focuses on improving sleep habits and nutrition, making it easier for participants to adhere to their treatment plan. Overall, these strategies show promise for enhancing treatment outcomes in people with sleep apnea. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Tennessee newly diagnosed with moderate to severe obstructive sleep apnea. It's open to all genders and ethnicities. Participants must be prescribed CPAP therapy for their condition.

Inclusion Criteria

My ethnicity does not affect my eligibility.

I live in Tennessee.

My gender does not affect my eligibility.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants attend a baseline assessment with their doctor, including standardized sleep tests and surveys on health, quality of life, and demographics.

1 visit

1 visit (in-person)

Treatment

Participants in the STANDARDCARE group receive weekly video health coaching sessions for 6 weeks, focusing on sleep, nutrition, and CPAP adherence. CONTROL group participants receive standard CPAP therapy.

6 weeks

6 visits (virtual) for STANDARDCARE group, 2 visits (in-person) for CONTROL group

Follow-up

Participants are monitored for adherence and effectiveness of CPAP therapy, with surveys completed at 6 weeks and 3 months.

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Health Coaching with Wearable Devices

Trial Overview The study compares two approaches: one group gets standard CPAP therapy, while the other combines CPAP with health coaching on weight management and sleep hygiene. The focus is on whether coaching improves treatment adherence and outcomes.

How Is the Trial Designed?

Group I: STANDARDCARE (STAND) group Experimental Treatment 1 Intervention

Participants will download the Apnimed App for daily sleep ring data collection, using it nightly and syncing data each morning. They will receive weekly video health coaching sessions for 6 weeks, focusing on sleep, nutrition, and CPAP adherence. Surveys will be completed at baseline, 6 weeks, and 3 months.

Group II: CONTROL (CON) group Experimental Treatment 1 Intervention

Participants in this group will receive no device and no health coaching.

Who Is Running the Clinical Trial?

Coastal Carolina University

Lead Sponsor

Trials

3

Recruited

130+

Apnimed

Industry Sponsor

Trials

17

Recruited

3,400+

inHealth Medical Services, Inc.

Collaborator

Trials

4

Recruited

150+

inHealth Medical Services, Inc.

Industry Sponsor

Citations

1. apnimed.com apnimed.com/wp-content/uploads/2025/05/sleep-372.pdf

The Role of Wearable Devices and Health Coaching The findings demonstrate improvements from baseline in PAP usage and OS post-HWC intervention. •The results suggest that HWC and CW could ...

2. academic.oup.com academic.oup.com/sleep/article/48/Supplement_1/A341/8135266

The Role of Wearable Devices and Health Coaching | SLEEP The findings demonstrate improvements from baseline in PAP usage and OS post-HWC intervention. The results suggest that HWC and CW could improve ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11422752/

Detection of Sleep Apnea Using Wearable AI - PubMed Central Wearable AI shows potential in identifying and classifying sleep apnea, but its current performance is suboptimal for routine clinical use.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2590238525003662

Article A wearable all-in-one obstructive sleep apnea ... A machine learning algorithm is leveraged to analyze the collected data, enabling real-time apnea detection accuracy of 92.7%. Rigorous ...

5. withpower.com withpower.com/trial/phase-sleep-apnea-obstructive-7-2024-85c11

Health Coaching for Sleep Apnea · Info for Participants ... Wearable Devices will have tolerable side effects & efficacy for patients with Obstructive Sleep Apnea and Obstructive Sleep Apnea. Learn more about the study.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S138994572500173X

World Sleep Society recommendations for the use of ... We outline best practices for using CHT-derived sleep data in healthy individuals while addressing current device limitations. Additionally, we explore ...

7. sleepandsinuscenters.com sleepandsinuscenters.com/blog/smartwatch-sleep-data-transforming-ent-care-and-diagnosis

Smartwatch Sleep Data: Transforming ENT Care and ... Wearables currently cannot detect all types of sleep apnea nor replace clinical evaluation and testing. Therefore, a diagnosis based solely on ...