Metabolism and Sleep Apnea Treatment
University of Miami
100 participants
May 20, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- Aim 1 Group:
- 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 Criteria23
- 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:
- 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%
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Interventions
Auto-PAP device (ResMed AirsenseTM Autoset) with a heated humidifier will be provided along with an appropriate mask and connecting hose for nightly use
Lifestyle intervention will include counseling on (a) education on nutrition and exercise; and (b) behavioral support for identifying lifestyle change strategies and problem-solving barriers to improve the regularity and duration of sleep. This will be conducted using brochures on weight loss and sleep hygiene
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05539716