Lifestyle Program for Obstructive Sleep Apnea With Severe Obesity

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Obesity
• Interventions: Behavioral: Home-based pulmonary rehabilitation (PR) system

• Registration Number: NCT05343000
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-25
• Study Start: 2024-02-03
• Status Verified: 2024-07
• Primary Completion: 2024-09-25
• Study Completion: 2024-09-25
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Adult patients, 18 years of age or older.
• Newly diagnosed with severe Obstructive Sleep Apnea (OSA) and severe obesity (BMI > 35).

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Severe Comorbid OSA	Home-based pulmonary rehabilitation (PR) system	Newly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system

Primary Outcome Measures

Name	Time	Method
Feasibility of proposed system in patients with OSA and Obesity	Qualitative Interviews will be completed at the end of the two week trial	Qualitative Interview

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States