Back to search results

Metabolism and Sleep Apnea Treatment Study

This study is looking into whether obstructive sleep apnea (OSA), a condition where breathing repeatedly stops and starts during sleep, is connected to problems with how your body processes fat. Researchers want to understand how fat is handled in people with and without sleep apnea, what substances fat tissue releases, and how these might affect your body's energy and sugar use. You might be able to join if you are between 18 and 70 years old and do not have certain health conditions like severe obesity (BMI > 40), heart problems, or diabetes. The study will measure your whole body fat breakdown rate over up to 3 months to see if the treatments are successful. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 100 participants. It involves two interventions: PAP Therapy using an Auto-PAP device and Lifestyle Counseling on nutrition, exercise, and sleep habits.
What's involved
Participants will receive an Auto-PAP device for nightly use and participate in lifestyle counseling. The primary measurement, whole body lipolysis rate, will be taken up to 3 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 months, based on the primary endpoint timeframe.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05539716

Metabolism and Sleep Apnea Treatment

Recruiting
NAAges 18–70InterventionalSupportive care
University of Miami
~100 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:PAP TherapyLifestyle Counseling Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Whole body lipolysis rate
Measured over Up to 3 months

Conditions

Obstructive Sleep Apnea
Fat Disorder

Explore related trials

Gait DisturbanceObstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Naresh Punjabi, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Naresh Punjabi, MD
[email protected]
305-243-3963
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.

Exclusion

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%
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%

What this trial measures

  • Whole body lipolysis rateUp to 3 months

    Measured using the Intravenous Glucose Tolerance Test (IVGTT) in micromoles/L/min assessed at baseline and again at 3 months