Actively Recruiting
Metabolism and Sleep Apnea Treatment
Led by University of Miami · Updated on 2026-03-23
100
Participants Needed
1
Research Sites
275 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metabolism and Sleep Apnea Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Ability to provide consent
- For Aim 2 group: moderate-to-severe obstructive sleep apnea (AHI ≥ 15/h)
- For Aim 2 group: demonstration of PAP use > 4 hours per night on 70% of nights during a 1-week run-in period
- For Aim 2 group: successful completion of all procedures for Aim 1
You will not qualify if you...
- Body Mass Index (BMI) greater than 40 kg/m2
- History of myocardial infarction, coronary revascularization, heart failure, or stroke
- Type 1 or Type 2 diabetes mellitus
- Current or prior use of PAP or oral appliance therapy for OSA (Aim 1) or current use for Aim 2
- Use of oral corticosteroids
- Unstable medical conditions including uncontrolled angina, congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, or active psychiatric disease such as major depression
- Presence of other sleep disorders such as circadian rhythm disorder or habitual sleep duration less than 6 hours
- Use of supplemental oxygen during wakefulness or sleep
- Central sleep apnea, obesity hypoventilation syndrome, or Cheyne-Stokes respiration based on home sleep test
- Resting awake oxygen saturation (SpO2) less than 90%
- For Aim 2 group: commercial driver or report of motor vehicle accident or near-miss due to sleepiness within the past 2 years
- For Aim 2 group: Epworth sleepiness score of 18 or more
- Participation in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33143
Actively Recruiting
Research Team
N
Naresh Punjabi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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