Clinical trial NCT04861038: Study Using Negative Pressure to Reduce Apnea
Official title: Study Using Negative Pressure to Reduce Apnea (SUPRA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Apnea, Obstructive
Apnea, Sleep
Keywords: sleep apnea
OSA
obstructive sleep apnea
CPAP failure
apnea
Lead sponsor: Sommetrics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Sustained response to aerSleep II therapy at 24 weeks
timeFrame: 24 weeks
measure: Adverse Device Effects
timeFrame: 24 weeks
Secondary outcomes:
measure: ODI change
timeFrame: 24 weeks
measure: AHI change from baseline for all subjects that acclimate to the aerSleep II device
timeFrame: 24 weeks
measure: Change in sleep disturbance from baseline as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire
timeFrame: 24 weeks
measure: Change in sleep impairment from baseline as measured by PROMIS Sleep Sleep-Related Impairment questionnaire
timeFrame: 24 weeks
measure: Change in sleep from baseline as measured by Patient Global Impression Scale questionnaire
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Los Angeles
country: United States
facility: Infinitive Bioresearch
state: California
city: San Diego
country: United States
facility: BetterNight
state: California
city: Colorado Springs
country: United States
facility: Delta Waves
state: Colorado
city: Miami
country: United States
facility: Baptist Hospital
state: Florida
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: Cleveland
country: United States
facility: The MetroHealth System
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Columbia
country: United States
facility: Bogan Sleep Consultants
state: South Carolina
city: Columbia
country: United States
facility: BioSerenity
state: South Carolina
city: San Antonio
country: United States
facility: Sleep Therapy & Research Center
state: Texas
Study officials:
affiliation: Case Western Reserve University School of Medicine
name: Kingman P. Strohl, M.D.
role: PRINCIPAL_INVESTIGATOR
References: