Study Using Negative Pressure to Reduce Apnea (SUPRA)

• ClinicalTrials.gov Identifier: NCT04861038
• Recruitment Status: Recruiting
• First Posted: April 27, 2021
• Last Update Posted: February 21, 2023
• Sponsor: Sommetrics, Inc.
• Information provided by (Responsible Party): Sommetrics, Inc.

Study Description

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 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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 900 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)
• Actual Study Start Date: November 29, 2021
• Estimated Primary Completion Date: September 2024
• Estimated Study Completion Date: September 2024

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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 ≤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

Contacts and Locations

Contacts

Contact: Eric Koehler; 760.295.5620; ekoehler@sommetrics.com

Contact: Richard Rose, M.D.; rrose@sommetrics.com

Locations

United States, Arizona

University of Arizona; Recruiting

Tucson, Arizona, United States, 85719

Contact: Chris Morton

Principal Investigator: Sairam Parthasarathy, MD

United States, Arkansas

Preferred Research Partners; Recruiting

Little Rock, Arkansas, United States, 72211

Contact: Stacy Tierney

Principal Investigator: Paul E. Wylie, MD

United States, California

Infinitive Bioresearch; Recruiting

Los Angeles, California, United States, 90048

Contact: Hassam Khan

Principal Investigator: Martin Hopp, M.D.

BetterNight; Recruiting

San Diego, California, United States, 92123

Contact: Christy Guerrero

Principal Investigator: Samuel Clark, MD

United States, Colorado

Delta Waves; Recruiting

Colorado Springs, Colorado, United States, 80918

Contact: Kimberly Vigil

Principal Investigator: Jon Olin, MD

United States, Florida

Baptist Hospital; Recruiting

Miami, Florida, United States, 33176

Contact: Margie McKercher

Principal Investigator: Harneet Walia, MD

United States, Missouri

Clayton Sleep Institute; Recruiting

Saint Louis, Missouri, United States, 63123

Contact: Matthew Uhles

Principal Investigator: Joseph Ojile, MD

United States, Ohio

The MetroHealth System; Active, not recruiting

Cleveland, Ohio, United States, 44109

Cleveland Clinic Foundation; Recruiting

Cleveland, Ohio, United States, 44195

Contact: Carla Obeid

Principal Investigator: Reena Mehra, MD

The Ohio State University; Recruiting

Columbus, Ohio, United States, 43210

Contact: Alicia Gonzalez Zacarias

Principal Investigator: Ulysses Magalang, MD

United States, Pennsylvania

Thomas Jefferson University; Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contact: Jay Shah

Principal Investigator: Colin Huntley, MD

UPMC; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contact: Pinar Garbioglu

Principal Investigator: Sanjay Patel, MD

United States, South Carolina

Bogan Sleep Consultants; Recruiting

Columbia, South Carolina, United States, 29201

Contact: Heather Byrd

Principal Investigator: Richard Bogan, MD

BioSerenity; Active, not recruiting

Columbia, South Carolina, United States, 29212

United States, Texas

Sleep Therapy & Research Center; Recruiting

San Antonio, Texas, United States, 78229

Contact: Skyler Edmisten

Principal Investigator: James Andry, MD

Sponsors and Collaborators

Sommetrics, Inc.

Investigators

• Principal Investigator: Kingman P. Strohl, M.D.; Case Western Reserve University School of Medicine

More Information

• Responsible Party: Sommetrics, Inc.
• ClinicalTrials.gov Identifier: NCT04861038
• Other Study ID Numbers: SOM-029
• First Posted: April 27, 2021
• Last Update Posted: February 21, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Sommetrics, Inc.:

sleep apnea; OSA; obstructive sleep apnea; CPAP failure; apnea

Additional relevant MeSH terms:

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