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Active, Not Recruiting

NCT Number: NCT06525337

Adherence to Health Coaching with Wearable Devices: Enhancing Patient Engagement and Outcomes

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Williams Brice Building, Conway, South Carolina, United States

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About this study

Purpose:

The purpose of this research study is to compare the effects of a wearable sleep ring combined with health coaching in the STANDARDCARE (STAND) group to a CONTROL (CON) group with no sleep ring and no health coaching. The investigators aim to see if this combination improves patient satisfaction and progress with using a CPAP machine.

Procedures:

If participants agree to participate, they will be asked to do the following:

Baseline Assessment:

Participants will attend a baseline assessment with their doctor that includes an overview and explanation of the study. They will conduct all standardized sleep tests as advised by their doctor. Upon meeting inclusion criteria, they will then be randomized to a STANDARDCARE (STAND) group or CONTROL (CON) group. During this time, body weight and height will be measured. Participants will then be asked to fill out several surveys that will involve questions related to overall health, quality of life, sleep adherence, and demographics (age, race).

STANDARDCARE GROUP (STAND):

If participants are randomized to this group, they will be asked to download one app. They will first be asked to download the Apnimed App, which will be used for collecting wearable sleep ring data daily. Participants will also be given step-by-step instructions on how to use the app. They will be asked to use the Apnimed sleep ring every night and sync data on the app in the morning. Following the initial baseline visit, participants will receive weekly individualized video health coaching sessions with a health coach through video conference using Zoom for 6 weeks. During these sessions, they will receive weekly educational online modules focusing on sleep, nutrition, and fitness centered on sleep science and adherence to the CPAP machine. Participants will be able to keep using the ring as much or as little as desired after the 6-week period. The research team will administer the final survey at 3 months following participants' first usage of the ring. Participants will fill out a survey at the beginning of the study, at 6 weeks, and 3 months after enrolling.

CONTROL GROUP (CON):

If participants are randomized to this group, they will not receive any wearable sleep ring or health coaching. They will have two visits with the study physician at baseline and at the end of the study. Participants will only be instructed to use the CPAP machine daily or undergo standard medical treatment as prescribed. They will be asked to fill out the surveys again at the end of 6 weeks and 3 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older
  • Both genders
  • All ethnicities
  • Must reside in the state of TN
  • Newly diagnosed with obstructive sleep apnea (OSA)
  • Prescribed with moderate to severe OSA.7). AHI of > 15

Exclusion criteria

  • Unable or unwilling to use wearable device,
  • end stage renal failure
  • heart failure or stroke
  • Although not anticipated for this study population, women cannot be or suspect they may be pregnant.

Treatment and study plan

STANDARDCARE (STAND) group

Behavioral

Will receive a device and health coaching

CONTROL (CON) group

Other

Will not use any devices or receive health coaching

Primary outcomes

  1. Oxygen Desaturation Index (ODI)

    Time frame: Daily for 90 days

    The ODI is a measurement that helps diagnose and manage obstructive sleep apnea (OSA) by quantifying how often and how much a person's blood oxygen level drops during sleep.

  2. Quality-of-life survey responses

    Time frame: Through Study Completion, an average of 3 months

    Quality-of-life survey responses assess an individual's overall well-being, encompassing physical, mental, and social health.

Sponsors and collaborators

Lead sponsor

Coastal Carolina University

Other

Collaborators

  • Apnimed
  • inHealth Medical Services, Inc.

Registry information

Official study title

Adherence of Health Coaching with Wearable Device

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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