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Negative Pressure Device for Sleep Apnea (SUPRA Trial)
SUPRA Trial Summary
This trial is testing a new device to treat sleep apnea in people who can't use CPAP. The device will be used at home for 24 weeks to see if it is safe and effective.
SUPRA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSUPRA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SUPRA Trial Design
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Who is running the clinical trial?
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- You have a mental health condition that is not being effectively managed with treatment, as determined by the study investigator.I do not have serious lung problems like severe asthma.I do not have serious heart conditions like heart failure or unstable heart disease.You have a history of stroke or TIA that may be related to issues with your carotid artery, or you have a significant blockage or abnormality in your carotid artery. Additionally, pregnancy, difficulties with fitting a collar or any condition that may affect study completion or accuracy of data collection may exclude you from participating. Lastly, the investigator may exclude you if they feel your participation is not in your best interest.I have had surgery or a procedure on my neck or heart arteries, or I have a severe narrowing in my neck arteries.I have had surgery for a condition affecting the blood flow in my limbs.is required
People must have a prior diagnosis of OSA in order to be eligible for this studyI am 18 years old or older.I have moderate sleep apnea, struggled with CPAP, and haven't used it or oral appliances in the last week.Approximately 80% of apneas and hypopneas are obstructive in nature.I have a sleep disorder that is not obstructive sleep apnea.I have facial abnormalities that might be causing my sleep apnea.I've had surgery, injury, or radiation to the neck that might affect wearing a collar.I am willing to shave my neck area if it has excessive hair for this study.I tried using CPAP for my condition but had to stop because it didn't work, I couldn't tolerate it, or I chose to stop.I am 18 years old or older.Your body mass index (BMI) is less than 38 kg/m2.You have used illegal drugs in the last 5 years or are currently using them.My cancer has been in remission for less than a year.The average person has an AHI of 15 - 50 per hour.This text states that the person can speak English, read English, and write English.You are allergic to silicone.You work night shifts and have an irregular sleep schedule.The investigator believes that the subject will be able to understand and comply with all study procedures.I haven't used CPAP or oral appliances for a week and won't use them during the study.I do not have skin conditions like acne or eczema where the device will be placed.
- Group 1: aerSleep II
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 5 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Frequently Asked Questions
To what degree can this research be found in various parts of the state?
"Currently, 16 sites across the country are admitting patients into this study. Residents of Pittsburgh, Little Rock and Columbus can take advantage of nearby locations while other cities provide further options to reduce travel demands for those who partake in the trial."
What goals are being pursued with this scientific investigation?
"The primary endpoint of this 24-week clinical trial is to gauge Adverse Device Effects. Secondary endpoints being evaluated include changes in sleep disturbance, as measured by the PROMIS Sleep Disturbance 8b questionnaire; sleep impairment, assessed through the PROMIS Short Form Sleep-Related Impairment 8a Questionnaire; and Oxygen Desaturation Index (ODI) at HST #4 relative to baseline for initial responders."
Are any new participants being recruited for this clinical experiment?
"Clinicaltrials.gov confirms that this trial, originally posted on November 29th 2021, is actively enrolling patients. The study has been edited to reflect new information as recently as November 8th 2022."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- BetterNight: < 48 hours
Typically responds via
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