Sleep Disorders Trial, Recruiting NCT05539716 Sponsor: University of Miami Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT05539716
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For the first part of the study (Aim 1):

  • You are between 18 and 70 years old
  • You are able to read and agree to a consent form

For the second part of the study (Aim 2), all of the above, plus:

  • You have moderate-to-severe sleep apnea, meaning your breathing stops or is disrupted at least 15 times per hour during sleep
  • You have been using a CPAP or similar breathing machine for more than 4 hours per night on at least 70% of nights during a one-week test period
  • You have successfully completed all steps from the first part of the study

Who may not be able to join:

For the first part of the study (Aim 1):

  • Your Body Mass Index (BMI) is 40 or above (a measure of weight relative to height)
  • You have previously had a heart attack, heart bypass surgery or stenting, heart failure, or a stroke
  • You have Type 1 or Type 2 diabetes
  • You are currently using or have previously used a CPAP machine or a dental/mouth device for sleep apnea
  • You take oral steroid medications (such as prednisone)
  • You have certain serious or unstable health conditions, such as uncontrolled chest pain, uncontrolled blood pressure, severe lung disease, cancer, or an active mental health condition like major depression
  • You have another sleep disorder, or you regularly sleep less than 6 hours per night
  • You use extra oxygen at any time, whether awake or asleep
  • Your sleep test shows a specific type of sleep apnea caused by the brain (central sleep apnea), a breathing problem related to obesity (obesity hypoventilation syndrome), or an abnormal breathing pattern called Cheyne-Stokes respiration (confirm with trial site)
  • Your blood oxygen level while awake and at rest is below 90%

For the second part of the study (Aim 2), all of the above, plus:

  • You are a commercial driver, or you have had a car accident or near-accident due to drowsiness in the past 2 years
  • Your score on a standard sleepiness questionnaire (Epworth Sleepiness Scale) is 18 or higher, indicating very severe daytime sleepiness
  • You are currently taking part in another clinical trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 5 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Naresh Punjabi, MD, University of Miami

Phone: 305-243-3963

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
20 May 2022
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Whole body lipolysis rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 5 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov