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Behavioral Intervention
Lifestyle Program for Obstructive Sleep Apnea with Obesity
N/A
Recruiting
Led By Roberto Benzo, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed with severe Obstructive Sleep Apnea (OSA) and severe obesity (BMI > 35).
Adult patients, 18 years of age or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up qualitative interviews will be completed at the end of the two week trial
Awards & highlights
Study Summary
This trial is testing a new remote monitoring system for people with severe obesity and sleep apnea. The system will provide health coaching to help participants make behavior changes that improve their health and quality of life.
Who is the study for?
This trial is for adults over 18 with severe obesity (BMI > 35) and newly diagnosed with severe Obstructive Sleep Apnea. It's not suitable for those under 18 or patients who can't provide accurate data or follow instructions due to serious neurological or psychiatric conditions.Check my eligibility
What is being tested?
The study is testing a home-based pulmonary rehabilitation system designed to help people with severe obesity and sleep apnea. The program includes remote monitoring and health coaching to encourage lifestyle changes that improve health and quality of life.See study design
What are the potential side effects?
Since the intervention involves lifestyle modification rather than medication, typical drug side effects are not expected. However, participants may experience fatigue or muscle soreness from increased physical activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am newly diagnosed with severe sleep apnea and have a BMI over 35.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ qualitative interviews will be completed at the end of the two week trial
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~qualitative interviews will be completed at the end of the two week trial
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of proposed system in patients with OSA and Obesity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Severe Comorbid OSAExperimental Treatment1 Intervention
Newly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,239 Previous Clinical Trials
3,771,584 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,221 Total Patients Enrolled
Roberto Benzo, MDPrincipal InvestigatorMayo Clinic
5 Previous Clinical Trials
220 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am newly diagnosed with severe sleep apnea and have a BMI over 35.I am able to understand and follow study instructions.I am under 18 years old.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Severe Comorbid OSA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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