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Study Using Negative Pressure to Reduce Apnea (SUPRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04861038
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : December 9, 2022
Sponsor:
Information provided by (Responsible Party):
Sommetrics, Inc.

Tracking Information
First Submitted Date  ICMJE April 22, 2021
First Posted Date  ICMJE April 27, 2021
Last Update Posted Date December 9, 2022
Actual Study Start Date  ICMJE November 29, 2021
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2021)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2021)
  • 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 reduction 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2021)
  • ODI change [ Time Frame: 24 weeks ]
    Demonstrate a change in Oxygen Desaturation Index (ODI) at HST #4 compared to baseline HST for initial responders
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2021)
  • ODI reduction [ Time Frame: 24 weeks ]
    Demonstrate a reduction in Oxygen Desaturation Index (ODI) at HST #4 compared to baseline HST for initial responders
  • AHI reduction 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 reduction in AHI after 24 weeks of home use with the aerSleep II device
  • Reduction in sleep disturbance from baseline as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire [ Time Frame: 24 weeks ]
    Determine the reduction in sleep disturbance at the end of the study compared to baseline using the validated PROMIS Short Form Sleep Disturbance 8b questionnaire
  • Reduction in sleep impairment from baseline as measured by PROMIS Sleep Sleep-Related Impairment questionnaire [ Time Frame: 24 weeks ]
    Determine the reduction in sleep impairment at the end of the study from baseline as measured by the validated PROMIS Short Form Sleep-Related Impairment 8a questionnaire
  • Improvement in sleep from baseline as measured by Patient Global Impression Scale questionnaire [ Time Frame: 24 weeks ]
    Determine any improvement in sleep at the end of the study from baseline as measured by the Patient Global Impression Scale questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Using Negative Pressure to Reduce Apnea
Official Title  ICMJE Study Using Negative Pressure to Reduce Apnea (SUPRA)
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.
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 fifteen 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Apnea, Obstructive
  • Apnea, Sleep
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Device: aerSleep II
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2022)
900
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2021)
200
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Body mass index ≤42 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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eric Koehler 760.295.5620 ekoehler@sommetrics.com
Contact: Richard Rose, M.D. rrose@sommetrics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04861038
Other Study ID Numbers  ICMJE SOM-029
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Sommetrics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sommetrics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kingman P. Strohl, M.D. Case Western Reserve University School of Medicine
PRS Account Sommetrics, Inc.
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP