Metabolism and Sleep Apnea Treatment (MaST)

University of Miami

Status

Enrolling

Conditions

Fat Disorder

Obstructive Sleep Apnea

Treatments

Behavioral: Lifestyle Counseling Intervention

Device: PAP Therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05539716

20210670

5R01HL146709-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and 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%

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 3 patient groups

No Intervention (Aim 1) Group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: PAP Therapy

Behavioral: Lifestyle Counseling Intervention

Lifestyle Intervention Only (Aim 2) Group

Experimental group

Description:

Treatment:

Behavioral: Lifestyle Counseling Intervention