Metabolism and Sleep Apnea Treatment

Last updated: November 26, 2024
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

Lifestyle Counseling Intervention

PAP Therapy

Clinical Study ID

NCT05539716
20210670
5R01HL146709-04
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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, andstroke

  • 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 orresistant hypertension, severe chronic obstructive pulmonary disease, cancer, andactive psychiatric disease (e.g., major depression)

  • Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleepduration < 6h)

  • Use of supplemental oxygen during wakefulness or sleep

  • Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respirationbased 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 thenights during 1-week run-in period

  • Successful completion of all of the procedures for Aim 1.

Exclusion

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 sleepinesswithin 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 orresistant hypertension, severe chronic obstructive pulmonary disease, cancer, andactive psychiatric disease (e.g., major depression)

  • Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleepduration < 6h)

  • Use of supplemental oxygen during wakefulness or sleep

  • Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respirationbased on the home sleep test

  • Resting awake SpO2 < 90%

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Lifestyle Counseling Intervention
Phase:
Study Start date:
May 20, 2022
Estimated Completion Date:
September 01, 2026

Connect with a study center

  • University of Miami

    Miami, Florida 33143
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.