Exploring the link between metabolism and sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research investigates the relationship between obstructive sleep apnea (OSA) and fat metabolism abnormalities. The study aims to evaluate how fat is metabolized in individuals with and without OSA, focusing on the substances released by fat tissue and their impact on energy and sugar utilization in the body. Participants will receive interventions including PAP therapy and lifestyle counseling to assess their effects on metabolic processes.

Why it matters

Who can join: the full rules

Aim 1 Group:

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 it's running

• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Naresh Punjabi, MD — University of Miami
• Study coordinator: Naresh Punjabi, MD
• Email: npunjabi@miami.edu
• Phone: 305-243-3963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.