- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04861038
Study Using Negative Pressure to Reduce Apnea (SUPRA)
April 15, 2024 updated by: Sommetrics, Inc.
Study Using Negative Pressure to Reduce Apnea (SUPRA)
The objective of this study is to determine the safety and effectiveness of the aerSleep® II device for treatment of moderate to severe Obstructive Sleep Apnea (OSA) over 24 weeks of home use in spontaneously breathing adult subjects who are intolerant of Continuous Positive Airway Pressure (CPAP) therapy.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a multi-center, single-arm, prospective, observational intervention study to determine the safety and effectiveness of the aerSleep II System.
Up to 900 subjects will be enrolled at up to 30 study sites in the United States and outside the United States to ensure that approximately 79 subjects who are termed initial responders can be evaluated after 24 weeks of home use with the aerSleep II device.
As part of screening and prior to intervention, home sleep testing will be performed to establish baseline apnea-hypopnea index (AHI).
Subjects meeting study criteria will wear the aerSleep II device at home.
After a 1-week period of acclimation, subjects will have a second HST (HST #2).
Initial responders with a ≥50% reduction in AHI from baseline with an AHI <20/hour will be continued on home treatment.
Non-responders will be discontinued from the study.
After 12 weeks, subjects will have an interim home sleep study.
After 24 weeks of home use, subjects will have HST #4 to determine the primary effectiveness endpoint.
Study Type
Interventional
Enrollment (Estimated)
900
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eric Koehler
- Phone Number: 760.295.5620
- Email: ekoehler@sommetrics.com
Study Contact Backup
- Name: Richard Rose, M.D.
- Email: rrose@sommetrics.com
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85719
- University of Arizona
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72211
- Preferred Research Partners
-
-
California
-
Los Angeles, California, United States, 90048
- Infinitive Bioresearch
-
San Diego, California, United States, 92123
- BetterNight
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80918
- Delta Waves
-
-
Florida
-
Miami, Florida, United States, 33176
- Baptist Hospital
-
-
Missouri
-
Saint Louis, Missouri, United States, 63123
- Clayton Sleep Institute
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, United States, 44109
- The MetroHealth System
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
-
Pittsburgh, Pennsylvania, United States, 15213
- UPMC
-
-
South Carolina
-
Columbia, South Carolina, United States, 29201
- Bogan Sleep Consultants
-
Columbia, South Carolina, United States, 29212
- BioSerenity
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Sleep Therapy & Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years old
- Body mass index ≤42 kg/m2
- Prior documented diagnosis of OSA by means of a polysomnography (PSG) test or home sleep test (HST)
Documented evidence from a screening HST following consent to demonstrate:
- AHI 15 - 50/hour
- >80% of the apneas and hypopneas are obstructive
- Previous treatment attempt with CPAP resulting in failure to treat or discontinuation due to intolerance, subject choice, or struggle to use CPAP
- Have not used CPAP or oral appliances within 1 week of the screening home sleep test and agree not to use CPAP or oral appliances throughout the study duration
- Access to and ability to use a smart device such as a smartphone or tablet
- Able to speak, read, and write English
- In the opinion of the investigator, the subject will be able to understand and comply with all study procedures.
Exclusion Criteria:
- Known sleep disorder other than OSA, such as narcolepsy, restless leg syndrome, idiopathic hypersomnolence or chronic insomnia
- Craniofacial abnormalities that may be contributing to OSA
- Previous surgery, injury, or radiation to the neck which, in the Investigator's judgment, could interfere with collar fit or comfort
- Excessive hair or beard in the area of the neck where the collar will be placed, and/or unwillingness to shave that area for the duration of this study
- Inflammatory skin condition, such as acne or eczema in the area where the collar will be affixed to the skin, which, in the Investigator's judgment, could interfere with collar fit or comfort
- Known silicone allergy
- Night shift work because of irregular sleep-wake cycles
- Excessive alcohol intake, defined as that leading to interference with work, home life, or the ability to optimally perform normal everyday duties and tasks
- Use of illicit drugs currently or within the past 5 years
- Serious pulmonary disease (e.g., cor pulmonale, CO2 retention, or poorly controlled asthma)
- Use of home oxygen or baseline oxygen saturation <94%
- Cancer that has been in remission for less than one year
- Psychiatric illness that, in the opinion of the Investigator, is not reasonably well-controlled with treatment
- Serious cardiac disease (e.g., congestive heart failure, unstable coronary artery disease, or poorly controlled rhythm disturbance)
- Prior carotid endarterectomy, prior percutaneous coronary angiography (including any placement of carotid stents), or known stenosis of either internal carotid artery > 70% from prior carotid imaging (e.g., carotid duplex ultrasound, angiography, computed tomography angiography, or magnetic resonance angiography)
- Previous surgery for peripheral arterial disease
Presence of possible or definite carotid artery disease, defined as any of the following:
- history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) with uncertain etiology that is compatible with carotid artery disease
- diminished carotid pulse on screening physical examination*
- > 70% stenosis in either extra-cranial internal carotid artery as determined by duplex ultrasound* (only performed on those who do not exhibit 17 a. or b.)
- Tonsil size 3 or 4 (Appendix C)*
- Currently pregnant* or planning to become pregnant during participation in this study
- Unable to obtain adequate collar fit*
- Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, or bias the results
- The investigator believes that the subject's participation may not be in his or her best interest
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: aerSleep II
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
|
Continuous negative external pressure (cNEP) system that maintains an open airway by applying negative pressure to the anterior neck via a soft silicone collar
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained response to aerSleep II therapy at 24 weeks
Time Frame: 24 weeks
|
The primary effectiveness endpoint is to demonstrate that a majority of adult subjects who are initial responders to aerSleep II therapy experience a change of at least 50% of their baseline AHI with an AHI rate less than 20 per hour at the final home sleep test at 24 weeks.
|
24 weeks
|
Adverse Device Effects
Time Frame: 24 weeks
|
The primary safety endpoint is to characterize the adverse device effects experienced throughout the study.
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ODI change
Time Frame: 24 weeks
|
Demonstrate a change in Oxygen Desaturation Index (ODI) at HST #4 compared to baseline HST for initial responders
|
24 weeks
|
AHI change from baseline for all subjects that acclimate to the aerSleep II device
Time Frame: 24 weeks
|
Determine the proportion of subjects that acclimate to the device that exhibit a change in AHI after 24 weeks of home use with the aerSleep II device
|
24 weeks
|
Change in sleep disturbance from baseline as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire
Time Frame: 24 weeks
|
Determine the change in sleep disturbance at the end of the study compared to baseline using the validated PROMIS Short Form Sleep Disturbance 8b questionnaire
|
24 weeks
|
Change in sleep impairment from baseline as measured by PROMIS Sleep Sleep-Related Impairment questionnaire
Time Frame: 24 weeks
|
Determine the change in sleep impairment at the end of the study from baseline as measured by the validated PROMIS Short Form Sleep-Related Impairment 8a questionnaire
|
24 weeks
|
Change in sleep from baseline as measured by Patient Global Impression Scale questionnaire
Time Frame: 24 weeks
|
Determine any change in sleep at the end of the study from baseline as measured by the Patient Global Impression Scale questionnaire
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kingman P. Strohl, M.D., Case Western Reserve University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2021
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
April 22, 2021
First Submitted That Met QC Criteria
April 22, 2021
First Posted (Actual)
April 27, 2021
Study Record Updates
Last Update Posted (Actual)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOM-029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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