Back to resultsLifestyle Program for Obstructive Sleep Apnea With Severe Obesity
Primary Purpose
Obstructive Sleep Apnea, Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based pulmonary rehabilitation (PR) system
Sponsored by
About this trial
This is an interventional supportive care trial for Obstructive Sleep Apnea
Eligibility Criteria
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).
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Severe Comorbid OSA
Arm Description
Newly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system
Outcomes
Primary Outcome Measures
Feasibility of proposed system in patients with OSA and Obesity
Qualitative Interview
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05343000
Brief Title
Lifestyle Program for Obstructive Sleep Apnea With Severe Obesity
Official Title
A Lifestyle Program for Severe Comorbid Obstructive Sleep Apnea With Severe Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Severe Comorbid OSA
Arm Type
Experimental
Arm Description
Newly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system
Intervention Type
Behavioral
Intervention Name(s)
Home-based pulmonary rehabilitation (PR) system
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of proposed system in patients with OSA and Obesity
Description
Qualitative Interview
Time Frame
Qualitative Interviews will be completed at the end of the two week trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna Hoult, MA
Phone
507-293-1989
Email
hoult.johanna@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Taylor
Phone
507-293-1989
Email
taylor.joshua@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Benzo, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Lifestyle Program for Obstructive Sleep Apnea With Severe Obesity
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