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Metabolism and Sleep Apnea Treatment (MaST)

Primary Purpose

Obstructive Sleep Apnea, Fat Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PAP Therapy
Lifestyle Counseling Intervention
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

No Intervention

Experimental

Experimental

Arm Label

No Intervention (Aim 1) Group

PAP Therapy and Lifestyle Intervention (Aim 2) Group

Lifestyle Intervention Only (Aim 2) Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Whole body lipolysis rate
Measured using the Intravenous Glucose Tolerance Test (IVGTT) in micromoles/L/min assessed at baseline and again at 3 months

Secondary Outcome Measures

Free Fatty Acids (FFA) Oxidation Rate
Measured using the IVGTT in micromoles/L/min assessed at baseline and again at 3 months
Adipocyte insulin resistance
Measured using the IVGTT in micromoles-microunits/L-ml assessed at baseline and again at 3 months
Lipolysis suppression slope
Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months
Free fatty acid rebound slope
Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 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
Insulin sensitivity
Measured using the IVGTT in (milliunits/L x min)^-1 assessed at baseline and again at 3 months
Acute insulin response to glucose
Measured using the IVGTT in (milliunits/L) x minute assessed at baseline and again at 3 months
Glucose effectiveness
Measured using the IVGTT in per minute assessed at baseline and again at 3 months

Full Information

First Posted
May 16, 2022
Last Updated
September 14, 2023
Sponsor
University of Miami
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05539716
Brief Title
Metabolism and Sleep Apnea Treatment
Acronym
MaST
Official Title
Metabolism and Sleep Apnea Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Fat Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Intervention (Aim 1) Group
Arm Type
No Intervention
Arm 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.
Arm Title
PAP Therapy and Lifestyle Intervention (Aim 2) Group
Arm Type
Experimental
Arm 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.
Arm Title
Lifestyle Intervention Only (Aim 2) Group
Arm Type
Experimental
Arm 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 only the Lifestyle Intervention for 12 weeks.
Intervention Type
Device
Intervention Name(s)
PAP Therapy
Intervention Description
Auto-PAP device (ResMed AirsenseTM Autoset) with a heated humidifier will be provided along with an appropriate mask and connecting hose for nightly use
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Counseling Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Whole body lipolysis rate
Description
Measured using the Intravenous Glucose Tolerance Test (IVGTT) in micromoles/L/min assessed at baseline and again at 3 months
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Free Fatty Acids (FFA) Oxidation Rate
Description
Measured using the IVGTT in micromoles/L/min assessed at baseline and again at 3 months
Time Frame
Up to 3 months
Title
Adipocyte insulin resistance
Description
Measured using the IVGTT in micromoles-microunits/L-ml assessed at baseline and again at 3 months
Time Frame
Up to 3 months
Title
Lipolysis suppression slope
Description
Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months
Time Frame
Up to 3 months
Title
Free fatty acid rebound slope
Description
Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months
Time Frame
Up to 3 months
Title
Free fatty acid insulin sensitivity parameter
Description
Measured using the IVGTT in (picomoles/L x min)^-1 assessed at baseline and again at 3 months
Time Frame
Up to 3 months
Title
Insulin sensitivity
Description
Measured using the IVGTT in (milliunits/L x min)^-1 assessed at baseline and again at 3 months
Time Frame
Up to 3 months
Title
Acute insulin response to glucose
Description
Measured using the IVGTT in (milliunits/L) x minute assessed at baseline and again at 3 months
Time Frame
Up to 3 months
Title
Glucose effectiveness
Description
Measured using the IVGTT in per minute assessed at baseline and again at 3 months
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naresh Punjabi, MD
Phone
305-243-3963
Email
npunjabi@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naresh Punjabi, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naresh Punjabi, MD
Phone
305-243-3963
Email
npunjabi@miami.edu
First Name & Middle Initial & Last Name & Degree
Naresh Punjabi, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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