Health Coaching for Sleep Apnea

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn how integrating health and wellness coaching (HWC) with Continuous Positive Airway Pressure (CPAP) therapy affects adherence to treatment and overall health outcomes in individuals with obstructive sleep apnea. The main questions it aims to answer are: * Does HWC improve CPAP adherence compared to standard care, in terms of device usage metrics (hours per night and days per month)? * How does combining HWC with weight management influence CPAP adherence and weight loss? * What are the differences in treatment outcomes between individuals receiving standard care and those receiving HWC? Researchers will compare two groups: * Standard Care Group: Participants receiving standard CPAP therapy without additional health coaching. * HWC Group: Participants receiving CPAP therapy combined with health and wellness coaching focused on weight management and sleep hygiene. Participants will: * Attend 2 in-office visits with a study physician (2 hours maximum) * Have 6 virtual visits via video with a study health coach (3 hours maximum) if in the HWC group This study aims to provide valuable insights into enhancing treatment outcomes for individuals with sleep apnea by integrating health coaching with CPAP therapy.

Eligibility Criteria

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 gender does not affect my eligibility.

My ethnicity does not affect my eligibility.

I live in Tennessee.

Timeline

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)

Treatment Details

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.

Participant Groups

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