Exploring the link between metabolism and sleep apnea
Metabolism and Sleep Apnea Treatment
NA · University of Miami · NCT05539716
This study is testing how sleep apnea affects fat metabolism and whether treatments like PAP therapy and lifestyle changes can improve energy and sugar use in people with this condition.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Miami (other) |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05539716 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 who can provide consent and do not have severe obesity or significant comorbid conditions.
Not a fit: Patients with a BMI over 40, diabetes, or other serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with obstructive sleep apnea by addressing metabolic dysfunction.
How similar studies have performed: While the specific approach of linking fat metabolism to sleep apnea is novel, related studies have shown promising results in understanding metabolic disorders associated with sleep conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Miami, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea, Fat Disorder