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Study Using Negative Pressure to Reduce Apnea (SUPRA)

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ClinicalTrials.gov Identifier: NCT04861038
Recruitment Status : Not yet recruiting
First Posted : April 27, 2021
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
Sommetrics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Apnea, Sleep Device: aerSleep II Not Applicable

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 200 subjects will be enrolled at up to ten study sites in 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Using Negative Pressure to Reduce Apnea (SUPRA)
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

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
Device: aerSleep II
Continuous negative external pressure (cNEP) system that maintains an open airway by applying negative pressure to the anterior neck via a soft silicone collar




Primary Outcome Measures :
  1. 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.

  2. Adverse Device Effects [ Time Frame: 24 weeks ]
    The primary safety endpoint is to characterize the adverse device effects experienced throughout the study.


Secondary Outcome Measures :
  1. ODI change [ Time Frame: 24 weeks ]
    Demonstrate a change in Oxygen Desaturation Index (ODI) at HST #4 compared to baseline HST for initial responders

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Body mass index <38 kg/m2
  3. Prior documented diagnosis of OSA by means of a polysomnography (PSG) test or home sleep test (HST)
  4. Documented evidence from a screening HST following consent to demonstrate:

    1. AHI 15 - 50/hour
    2. >80% of the apneas and hypopneas are obstructive
  5. Previous treatment attempt with CPAP resulting in failure to treat or discontinuation due to intolerance, subject choice, or struggle to use CPAP
  6. 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
  7. Access to and ability to use a smart device such as a smartphone or tablet
  8. Able to speak, read, and write English
  9. In the opinion of the investigator, the subject will be able to understand and comply with all study procedures.

Exclusion Criteria:

  1. Known sleep disorder other than OSA, such as narcolepsy, restless leg syndrome, idiopathic hypersomnolence or chronic insomnia
  2. Craniofacial abnormalities that may be contributing to OSA
  3. Previous surgery, injury, or radiation to the neck which, in the Investigator's judgment, could interfere with collar fit or comfort
  4. 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
  5. 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
  6. Known silicone allergy
  7. Night shift work because of irregular sleep-wake cycles
  8. Excessive alcohol intake, defined as that leading to interference with work, home life, or the ability to optimally perform normal everyday duties and tasks
  9. Use of illicit drugs (including marijuana) currently or within the past 5 years
  10. Serious pulmonary disease (e.g., cor pulmonale, CO2 retention, or poorly controlled asthma)
  11. Use of home oxygen or baseline oxygen saturation <94%
  12. Cancer that has been in remission for less than one year
  13. Psychiatric illness that, in the opinion of the Investigator, is not reasonably well-controlled with treatment
  14. Serious cardiac disease (e.g., congestive heart failure, unstable coronary artery disease, or poorly controlled rhythm disturbance)
  15. 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)
  16. Previous surgery for peripheral arterial disease
  17. Presence of possible or definite carotid artery disease, defined as any of the following:

    1. history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) with uncertain etiology that is compatible with carotid artery disease
    2. diminished carotid pulse on screening physical examination*
    3. > 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.)
  18. Tonsil size 3 or 4 (Appendix C)*
  19. Currently pregnant* or planning to become pregnant during participation in this study
  20. Unable to obtain adequate collar fit*
  21. Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, or bias the results
  22. The investigator believes that the subject's participation may not be in his or her best interest

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04861038


Contacts
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Contact: Eric Koehler 760.295.5620 ekoehler@sommetrics.com
Contact: Richard Rose, M.D. rrose@sommetrics.com

Locations
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United States, Florida
Baptist Hospital
Miami, Florida, United States, 33176
Contact: Yudmilla Barbon         
Principal Investigator: Harneet Walia, MD         
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43210
Contact: Alicia Gonzalez Zacarias         
Principal Investigator: Ulysses Magalang, MD         
United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Contact: Shirley Longinotti         
Principal Investigator: Sanjay Patel, MD         
United States, South Carolina
Bogan Sleep Consultants
Columbia, South Carolina, United States, 29201
Contact: Heather Byrd         
Principal Investigator: Richard Bogan, MD         
BioSerenity
Columbia, South Carolina, United States, 29212
Contact: Alisha Henderson         
Principal Investigator: Alyssa Cairns, PhD         
Sponsors and Collaborators
Sommetrics, Inc.
Investigators
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Principal Investigator: Kingman P. Strohl, M.D. Case Western Reserve University School of Medicine
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Responsible Party: Sommetrics, Inc.
ClinicalTrials.gov Identifier: NCT04861038    
Other Study ID Numbers: SOM-029
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases