Image

Metabolism and Sleep Apnea Treatment

Metabolism and Sleep Apnea Treatment

Recruiting
18-70 years
All
Phase N/A

Powered by AI

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.

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%

Study details
    Obstructive Sleep Apnea
    Fat Disorder

NCT05539716

University of Miami

29 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.