Sleep Apnea, ObstructiveSUPRANCT04861038
Study Using Negative Pressure to Reduce Apnea
A study testing aerSleep II in people with Sleep Apnea, Obstructive and Apnea, Sleep, run by Sommetrics, Inc. at 15 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Apnea, Sleep
- What is being tested?
- aerSleep II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 15 sitesUnited States
- Study dates
- 29 Nov 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
The MetroHealth System
Cleveland, Ohio, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Delta Waves
Colorado Springs, Colorado, 80918
Bogan Sleep Consultants
Columbia, South Carolina, 29201
BioSerenity
Columbia, South Carolina, 29212
The Ohio State University
Columbus, Ohio, 43210
Preferred Research Partners
Little Rock, Arkansas, 72211
Infinitive Bioresearch
Los Angeles, California, 90048
Baptist Hospital
Miami, Florida, 33176
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
UPMC
Pittsburgh, Pennsylvania, 15213
Sleep Therapy & Research Center
San Antonio, Texas, 78229
BetterNight
San Diego, California, 92123
Clayton Sleep Institute
St Louis, Missouri, 63123
University of Arizona
Tucson, Arizona, 85719
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive, Apnea, Sleep
- Being tested
- aerSleep II
- Keywords
- sleep apnea, OSA, obstructive sleep apnea, CPAP failure, apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerSleep IIDevice
Continuous negative external pressure (cNEP) system that maintains an open airway by applying negative pressure to the anterior neck via a soft silicone collar
| Study group | Role | What they receive |
|---|---|---|
| aerSleep II | Experimental | 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 Receives: Device: aerSleep II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained response to aerSleep II therapy at 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.
Measured: 24 weeks
Adverse Device Effects
The primary safety endpoint is to characterize the adverse device effects experienced throughout the study.
Measured: 24 weeks
Secondary outcomes (5)
ODI change
Demonstrate a change in Oxygen Desaturation Index (ODI) at HST #4 compared to baseline HST for initial responders
Measured: 24 weeks
AHI change from baseline for all subjects that acclimate to the aerSleep II device
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
Measured: 24 weeks
Change in sleep disturbance from baseline as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire
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
Measured: 24 weeks
Change in sleep impairment from baseline as measured by PROMIS Sleep Sleep-Related Impairment questionnaire
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
Measured: 24 weeks
Change in sleep from baseline as measured by Patient Global Impression Scale questionnaire
Determine any change in sleep at the end of the study from baseline as measured by the Patient Global Impression Scale questionnaire
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start29 Nov 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sommetrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kingman P. Strohl, M.D., Principal investigator, Case Western Reserve University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861038
- Sponsor's protocol ID
- SOM-029
- Acronym
- SUPRA
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2021
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Using Negative Pressure to Reduce Apnea (SUPRA)
- ClinicalTrials.gov ID
- NCT04861038
- Acronym / sponsor ID
- SUPRA / SOM-029
- Conditions
- Sleep Apnea, Obstructive, Apnea, Sleep
- Keywords
- sleep apnea, OSA, obstructive sleep apnea, CPAP failure, apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Sommetrics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aerSleep II | Experimental | Device: aerSleep IIUse 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Previous treatment attempt with CPAP resulting in failure to treat or discontinuation due to intolerance, subject choice, or struggle to use CPAP
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerSleep IIContinuous negative external pressure (cNEP) system that maintains an open airway by applying negative pressure to the anterior neck via a soft silicone collar | Device | aerSleep II |
Primary outcome
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.
Adverse Device Effects
Time frame: 24 weeks
The primary safety endpoint is to characterize the adverse device effects experienced throughout the study.
5 secondary outcomes
ODI change
Time frame: 24 weeks
AHI change from baseline for all subjects that acclimate to the aerSleep II device
Time frame: 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
Change in sleep impairment from baseline as measured by PROMIS Sleep Sleep-Related Impairment questionnaire
Time frame: 24 weeks
Change in sleep from baseline as measured by Patient Global Impression Scale questionnaire
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kingman P. Strohl, M.D. principal investigator
Case Western Reserve University School of Medicine
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerSleep II in people with Sleep Apnea, Obstructive and Apnea, Sleep, run by Sommetrics, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained response to aerSleep II therapy at 24 weeks (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.