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Behavioral Intervention

Lifestyle Program for Obstructive Sleep Apnea with Obesity

N/A
Waitlist Available
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 below
Select...
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 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

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

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,814 Previous Clinical Trials
47,291,043 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,296 Total Patients Enrolled
Roberto Benzo, MDPrincipal InvestigatorMayo Clinic
5 Previous Clinical Trials
220 Total Patients Enrolled

Media Library

Home-based pulmonary rehabilitation (PR) system (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05343000 — N/A
Obstructive Sleep Apnea Research Study Groups: Severe Comorbid OSA
Obstructive Sleep Apnea Clinical Trial 2023: Home-based pulmonary rehabilitation (PR) system Highlights & Side Effects. Trial Name: NCT05343000 — N/A
Home-based pulmonary rehabilitation (PR) system (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05343000 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research venture have any available openings?

"According to clinicaltrials.gov, this specific research initiative is no longer recruiting patients. The trial was initially posted on December 1st 2022 and the last update occured on October 31st 2022. Although this study has concluded recruitment, there are still 1295 other trials currently seeking participants."

Answered by AI
~9 spots leftby Aug 2024