Obstructive Sleep ApneaMaSTNCT05539716
Metabolism and Sleep Apnea Treatment
A study testing PAP Therapy and Lifestyle Counseling Intervention in people with Obstructive Sleep Apnea and Fat Disorder, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Fat Disorder
- What is being tested?
- PAP Therapy and Lifestyle Counseling Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2022to 1 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33143
Naresh Punjabi, MD, 305-243-3963, npunjabi@miami.edu
Naresh Punjabi, MD
About this study
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.
- Conditions
- Obstructive Sleep Apnea, Fat Disorder
- Being tested
- PAP Therapy, Lifestyle Counseling Intervention
- Medical subject headings
- Sleep Apnea, Obstructive, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAP TherapyDevice
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 Counseling InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| No Intervention (Aim 1) Group | No intervention | 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. |
| PAP Therapy and Lifestyle Intervention (Aim 2) Group | Experimental | 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. Receives: Device: PAP Therapy; Behavioral: Lifestyle Counseling Intervention |
| Lifestyle Intervention Only (Aim 2) Group | Experimental | 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. Receives: Behavioral: Lifestyle Counseling Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body lipolysis rate
Measured using the Intravenous Glucose Tolerance Test (IVGTT) in micromoles/L/min assessed at baseline and again at 3 months
Measured: Up to 3 months
Secondary outcomes (8)
Free Fatty Acids (FFA) Oxidation Rate
Measured using the IVGTT in micromoles/L/min assessed at baseline and again at 3 months
Measured: Up to 3 months
Adipocyte insulin resistance
Measured using the IVGTT in micromoles-microunits/L-ml assessed at baseline and again at 3 months
Measured: Up to 3 months
Lipolysis suppression slope
Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months
Measured: Up to 3 months
Free fatty acid rebound slope
Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months
Measured: Up to 3 months
Free fatty acid insulin sensitivity parameter
Measured using the IVGTT in (picomoles/L x min)^-1 assessed at baseline and again at 3 months
Measured: Up to 3 months
Insulin sensitivity
Measured using the IVGTT in (milliunits/L x min)^-1 assessed at baseline and again at 3 months
Measured: Up to 3 months
Acute insulin response to glucose
Measured using the IVGTT in (milliunits/L) x minute assessed at baseline and again at 3 months
Measured: Up to 3 months
Glucose effectiveness
Measured using the IVGTT in per minute assessed at baseline and again at 3 months
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start20 May 2022
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Naresh Punjabi, University of Miami
- Investigators
- Naresh Punjabi, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539716
- Sponsor's protocol ID
- 20210670
- Other IDs
- 5R01HL146709-04
- Acronym
- MaST
- Status last verified
- Mar 2026
- First submitted
- 16 May 2022
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No