Lifestyle Counseling + PAP Therapy for Obstructive Sleep Apnea
(MaST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this research study is to see if obstructive sleep apnea (OSA) is associated with abnormalities in fat metabolism. Through this research study, the Investigator will evaluate how fat is metabolized in people with and without sleep apnea, what substances the fat tissue releases, and how these substances might change the way the body uses energy and sugar.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use oral corticosteroids or have unstable medical conditions. It's best to discuss your specific medications with the trial team.
Is lifestyle counseling and PAP therapy safe for humans?
Lifestyle counseling, which includes techniques like motivational interviewing, is generally considered safe and is used to help people adopt healthier habits. PAP therapy, including CPAP, BiPAP, and APAP, is widely used for treating sleep apnea and is generally safe, though some people may experience minor side effects like nasal congestion or discomfort.12345
How is the Lifestyle Counseling + PAP Therapy treatment for obstructive sleep apnea different from other treatments?
This treatment is unique because it combines lifestyle counseling, which helps patients make healthier choices, with PAP therapy, a common method that uses air pressure to keep airways open during sleep. The combination aims to improve adherence and effectiveness by addressing both behavioral and physical aspects of sleep apnea.678910
What data supports the effectiveness of the treatment Lifestyle Counseling + PAP Therapy for Obstructive Sleep Apnea?
Research shows that lifestyle counseling, which includes motivational interviewing and brief action planning, can help patients adopt healthier behaviors by increasing their motivation and commitment to change. This approach, combined with the use of PAP therapy (a machine that helps keep your airways open while you sleep), may improve outcomes for patients with obstructive sleep apnea by addressing both behavioral and physical aspects of the condition.1231112
Who Is on the Research Team?
Naresh Punjabi, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with moderate-to-severe obstructive sleep apnea who can use a PAP device for at least 4 hours on most nights. It's not for those with diabetes, severe heart conditions, certain sleep disorders, or a BMI over 40. Participants should not be using other OSA treatments or involved in another clinical study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Lifestyle Intervention and/or PAP therapy for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lifestyle Counseling Intervention
- PAP Therapy
Lifestyle Counseling Intervention is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator