Metabolism and Sleep Apnea Treatment
Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:
• Age between 18-70 years
• Ability to provide consent
• Age between 18-70 years
• Ability to provide consent
• Moderate-to-severe OSA (AHI ≥ 15/h);
• Demonstration of Positive Airway Pressure (PAP) use of \> 4 h/night on 70% of the nights during 1-week run-in period
• Successful completion of all of the procedures for Aim 1.
Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Naresh Punjabi, MD
npunjabi@miami.edu
305-243-3963
Time Frame
Start Date: 2022-05-20
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 100
Treatments
No_intervention: No Intervention (Aim 1) Group
Participants in this group will not receive an intervention and will only undergo several testing procedures conducted within 3 to 4 weeks to assess OSA severity.
Experimental: PAP Therapy and Lifestyle Intervention (Aim 2) Group
Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive the PAP therapy and Lifestyle Intervention for 12 weeks.
Experimental: Lifestyle Intervention Only (Aim 2) Group
Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive only the Lifestyle Intervention for 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: University of Miami
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)