Metabolism and Sleep Apnea Treatment

Obstructive Sleep Apnea Clinical Trial

— MaST  

Official title:

Metabolism and Sleep Apnea Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05539716
• Other study ID #: 20210670
• Secondary ID: 5R01HL146709-04
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: January 2024
• Source: University of Miami
• Contact: Naresh Punjabi, MD
• Phone: 305-243-3963
• Email: npunjabi[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 might change the way the body uses energy and sugar.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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%

Related Conditions & MeSH terms

• Apnea
• Fat Disorder
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• PAP Therapy
Auto-PAP device (ResMed AirsenseTM Autoset) with a heated humidifier will be provided along with an appropriate mask and connecting hose for nightly use

Behavioral:
• Lifestyle Counseling Intervention
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

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole body lipolysis rate	Measured using the Intravenous Glucose Tolerance Test (IVGTT) in micromoles/L/min assessed at baseline and again at 3 months	Up to 3 months
Secondary	Free Fatty Acids (FFA) Oxidation Rate	Measured using the IVGTT in micromoles/L/min assessed at baseline and again at 3 months	Up to 3 months
Secondary	Adipocyte insulin resistance	Measured using the IVGTT in micromoles-microunits/L-ml assessed at baseline and again at 3 months	Up to 3 months
Secondary	Lipolysis suppression slope	Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months	Up to 3 months
Secondary	Free fatty acid rebound slope	Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months	Up to 3 months
Secondary	Free fatty acid insulin sensitivity parameter	Measured using the IVGTT in (picomoles/L x min)^-1 assessed at baseline and again at 3 months	Up to 3 months
Secondary	Insulin sensitivity	Measured using the IVGTT in (milliunits/L x min)^-1 assessed at baseline and again at 3 months	Up to 3 months
Secondary	Acute insulin response to glucose	Measured using the IVGTT in (milliunits/L) x minute assessed at baseline and again at 3 months	Up to 3 months
Secondary	Glucose effectiveness	Measured using the IVGTT in per minute assessed at baseline and again at 3 months	Up to 3 months