Skip to main content
OpenTrials
Completed

NCT Number: NCT05343000

Lifestyle Program for Obstructive Sleep Apnea With Severe Obesity

The purpose of this study is to develop a data driven system for persons with severe obesity sleep apnea that utilizes remote monitoring with health coaching to create behavior changes aimed at improving health and quality of life.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea Apnea Body Weight Dyssomnias Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, 18 years of age or older.
  • Diagnosis of Obstructive Sleep Apnea (OSA) and obesity (BMI > or = to 35).

Exclusion criteria

  • Individuals < 18 years of age.
  • Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

Treatment and study plan

Home-based pulmonary rehabilitation (PR) system

Behavioral

Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors upload the patient's activities, physiological data, and answers to the daily self-report questions to a secure website. This website also allows health coaches to view patient data via overview, weekly, daily, and trend reports. Health coaches call patients regularly to celebrate progress, assist with any issues, and set new goals.

Primary outcomes

  1. Ability to Use the Devices at Home

    Time frame: 2 Weeks

    The number of participants who were able to utilize the devices at home.

  2. Usability of Proposed System in Patients With OSA and Obesity

    Time frame: 2 Weeks

    Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the ease of using the technology on a scale of 1 to 10 (1=very difficult, 10=very easy), with higher scores indicating a better outcome.

  3. Helpfulness of Set-up Instructions of Proposed System in Patients With OSA and Obesity

    Time frame: 2 Weeks

    Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the helpfulness of the setup instructions from 1 to 10 (1=not at all helpful, 10=very helpful), with lower scores indicating a worse outcome.

Secondary outcomes

  1. Participant Reported Confidence Using Proposed System in Patients With OSA and Obesity

    Time frame: 2 Weeks

    Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. The number of participants who rated their confidence in using the proposed system greater than a 6 on a 10-point scale. The scale ranged from 1=not confident to 10=very confident, with higher scores indicating greater confidence.

  2. Perceived Benefit of Proposed System in Patients With OSA and Obesity

    Time frame: 2 Weeks

    Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. The number of participants who rated their perceived benefit from the system greater than a 7 on a 10-point scale. The scale ranged from 1=not beneficial to 10=very beneficial, with higher scores indicating greater benefit.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Minnesota HealthSolutions
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

A Lifestyle Program for Severe Comorbid Obstructive Sleep Apnea With Severe Obesity

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 25, 2022
Registry last updated
Oct 16, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.