Obstructive Sleep Apnea study: PAP Therapy
Official title Metabolism and Sleep Apnea Treatment
ClinicalTrials.gov ID: NCT05539716
What this study is testing
- What it's testing
- Researchers want to see if obstructive sleep apnea is linked to abnormal fat metabolism, including the substances fat tissue releases and how they affect energy and sugar use.
- Who it's for
- Adults who have sleep apnea or who do not have sleep apnea.
- What's involved
- Participants will have their fat metabolism and related substances measured to compare those with and without sleep apnea.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Age between 18-70 years
- Ability to provide consent
You likely can't join if
- 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...
See the full eligibility criteria
- Age between 18-70 years
- Ability to provide consent
- 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...
- 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
- 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
- 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...
- 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%
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.