Lifestyle Program for Obstructive Sleep Apnea With Severe Obesity

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05343000

Collaborator

(none)

Enrollment

Location

Arm

6.9

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea Obesity	Behavioral: Home-based pulmonary rehabilitation (PR) system	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pilot studyPilot study

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Severe Comorbid OSA Newly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system	Behavioral: Home-based pulmonary rehabilitation (PR) system 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.

Arm

Intervention/Treatment

Experimental: Severe Comorbid OSA

Newly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system

Behavioral: Home-based pulmonary rehabilitation (PR) system

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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