Clinical Trials Logo
  1. Home
  2. Obesity
  3. NCT05343000
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2