Metabolism and Sleep Apnea Treatment (MaST)
Obstructive Sleep Apnea, Fat Disorder
About this trial
This is an interventional supportive care trial for Obstructive Sleep Apnea
Eligibility 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%
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
No Intervention (Aim 1) Group
PAP Therapy and Lifestyle Intervention (Aim 2) Group
Lifestyle Intervention Only (Aim 2) Group
Participants in this group will not receive an intervention and will only undergo several testing procedures conducted within 3 to 4 weeks to assess OSA severity.
Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive the PAP therapy and Lifestyle Intervention for 12 weeks.
Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive only the Lifestyle Intervention for 12 weeks.