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Negative Pressure Device

Negative Pressure Device for Sleep Apnea (SUPRA Trial)

N/A
Waitlist Available
Led By Kingman P. Strohl, M.D.
Research Sponsored by Sommetrics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old
Age ≥ 18 years old
Timeline
Screening 3 days
Treatment 5 months
Follow Up 3 days
Awards & highlights

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.

Who is the study for?
Adults over 18 with a BMI ≤42 kg/m2 who have moderate to severe Obstructive Sleep Apnea (AHI 15 - 50/hour) and are intolerant of CPAP therapy. Participants must not have used CPAP or oral appliances for at least a week before the study, be able to use smart devices, and read/write English. Exclusions include previous neck surgeries, oxygen use, other sleep disorders, certain heart conditions, drug abuse history, psychiatric illness not well-controlled by treatment.Check my eligibility
What is being tested?
The aerSleep II device is being tested for its safety and effectiveness in treating Obstructive Sleep Apnea over a period of 24 weeks. The trial involves adults who can't tolerate standard CPAP therapy using this new device at home to see if it improves their condition.See study design
What are the potential side effects?
While specific side effects are not listed here, potential issues could arise from wearing the aerSleep II device such as skin irritation where the collar is placed or discomfort due to fit. It's important that participants report any adverse reactions they experience during the trial.

SUPRA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am 18 years old or older.
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I have moderate sleep apnea, struggled with CPAP, and haven't used it or oral appliances in the last week.

SUPRA Trial Timeline

Screening ~ 3 days
Treatment ~ 5 months
Follow Up ~3 days
This trial's timeline: 3 days for screening, 5 months for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Device Effects
Sustained response to aerSleep II therapy at 24 weeks
Secondary outcome measures
AHI change from baseline for all subjects that acclimate to the aerSleep II device
Change in sleep disturbance from baseline as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire
Change in sleep from baseline as measured by Patient Global Impression Scale questionnaire
+2 more

SUPRA Trial Design

1Treatment groups
Experimental Treatment
Group I: aerSleep IIExperimental Treatment1 Intervention
Use of aerSleep II device to provide continuous external negative pressure to treat moderate to severe OSA in spontaneously breathing subjects who are intolerant of CPAP

Find a Location

Who is running the clinical trial?

Sommetrics, Inc.Lead Sponsor
6 Previous Clinical Trials
83 Total Patients Enrolled
Kingman P. Strohl, M.D.Principal InvestigatorCase Western Reserve University School of Medicine
1 Previous Clinical Trials

Media Library

aerSleep II (Negative Pressure Device) Clinical Trial Eligibility Overview. Trial Name: NCT04861038 — N/A
Obstructive Sleep Apnea Research Study Groups: aerSleep II
Obstructive Sleep Apnea Clinical Trial 2023: aerSleep II Highlights & Side Effects. Trial Name: NCT04861038 — N/A
aerSleep II (Negative Pressure Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04861038 — N/A
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT04861038 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

What is the total population size of participants in this clinical trial?

"The study necessitates 250 qualified participants, which can be sourced from UPMC in Pittsburgh, Arkansas and Preferred Research Partners in Little Rock, Ohio."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
Florida
Other
California
How old are they?
18 - 65
What site did they apply to?
Baptist Hospital
Thomas Jefferson University
Other
BetterNight
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
2
1
0

Why did patients apply to this trial?

I would like to try this. I have tried a cpap and Bipap and do not like. I have OSA, and I tried the CPAP, but could not use it.
PatientReceived no prior treatments
I have tried to use CPAP several times can't tolerate it. I’ve tried several different mask with my Airsence 10 and continue to have issues.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Does it work right away? If it is a device and it works , what happens after the trial is over?
PatientReceived no prior treatments
How long are the visits? I’m a patient with Bogan Sleep Med now is that an issue?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. BetterNight: < 48 hours
Typically responds via
Phone Call
Email
~136 spots leftby Sep 2024