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Recruiting NCT05539716

Metabolism and Sleep Apnea Treatment

No phase Interventional Obstructive Sleep Apnea Fat Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PAP Therapy, Lifestyle Counseling Intervention.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea, Fat Disorder. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Whole body lipolysis rate [Time frame: Up to 3 months]
Secondary outcome measures (8)
  • Free Fatty Acids (FFA) Oxidation Rate [Time frame: Up to 3 months]
  • Adipocyte insulin resistance [Time frame: Up to 3 months]
  • Lipolysis suppression slope [Time frame: Up to 3 months]
  • Free fatty acid rebound slope [Time frame: Up to 3 months]
  • Free fatty acid insulin sensitivity parameter [Time frame: Up to 3 months]
  • Insulin sensitivity [Time frame: Up to 3 months]
  • Acute insulin response to glucose [Time frame: Up to 3 months]
  • Glucose effectiveness [Time frame: Up to 3 months]

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%

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT05539716 · 20210670 · 5R01HL146709-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗