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NCT05343000 Clinical Trial

Lifestyle Program for Obstructive Sleep Apnea With Severe Obesity

Obesity Clinical Trial

Official title:
A Lifestyle Program for Severe Comorbid Obstructive Sleep Apnea With Severe Obesity

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05343000
Other study ID # 21-011497
Secondary ID R43HL162131
Status Recruiting
Phase N/A
First received
Last updated
Start date February 3, 2024
Est. completion date August 2024

Study information
Verified date April 2024
Source Mayo Clinic
Contact Johanna Hoult, MA
Phone 507-293-1989
Email hoult.johanna@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility of proposed system in patients with OSA and Obesity Qualitative Interview Qualitative Interviews will be completed at the end of the two week trial
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