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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.

Must not have

Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

Individuals < 18 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up qualitative interviews will be completed at the end of the two week trial

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am newly diagnosed with severe sleep apnea and have a BMI over 35.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able to understand and follow study instructions.

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I am under 18 years old.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and qualitative interviews will be completed at the end of the two week trial for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of proposed system in patients with OSA and Obesity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met