NCT05539716 · University of Miami
Metabolism and Sleep Apnea Treatment
(MaST)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age between 18-70 years
- Ability to provide consent
Exclusion criteria
- Body Mass Index (BMI) \> 40 kg/m2
- Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
- Type 1 or Type 2 diabetes mellitus
- Current or prior use of PAP or oral appliance therapy for OSA
- Use of oral corticosteroids
- Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
- Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration \< 6h)
- Use of supplemental oxygen during wakefulness or sleep
- Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep test
- Resting awake Oxygen Saturation (SpO2) \< 90% Aim 2 Group: Inclusion criteria:
- 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. Exclusion criteria:
- BMI: ≥ 40 kg/m2
- Type 1 or Type 2 diabetes mellitus
- Current use of PAP or oral appliance therapy for OSA
- Commercial driver or report of motor vehicle accident or near-miss due to sleepiness within the 2 previous years
- Epworth sleepiness score of 18 or more
- Use of oral corticosteroids
- Participation in another clinical trial
- Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
- Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration \< 6h)
- Use of supplemental oxygen during wakefulness or sleep
- Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep test
- Resting awake SpO2 \< 90%
Where
- Miami, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 23, 2026 · Source of record for eligibility and locations