Study Using Negative Pressure to Reduce Apnea (SUPRA)

April 15, 2024 updated by: Sommetrics, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • University of Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners
    • California
      • Los Angeles, California, United States, 90048
        • Infinitive Bioresearch
      • San Diego, California, United States, 92123
        • BetterNight
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Delta Waves
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63123
        • Clayton Sleep Institute
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44109
        • The MetroHealth System
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Bogan Sleep Consultants
      • Columbia, South Carolina, United States, 29212
        • BioSerenity
    • Texas
      • San Antonio, Texas, United States, 78229
        • Sleep Therapy & Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 weeks
Adverse Device Effects
Time Frame: 24 weeks
The primary safety endpoint is to characterize the adverse device effects experienced throughout the study.
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ODI change
Time Frame: 24 weeks
Demonstrate a change in Oxygen Desaturation Index (ODI) at HST #4 compared to baseline HST for initial responders
24 weeks
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
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
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
24 weeks
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
24 weeks
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sommetrics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kingman P. Strohl, M.D., Case Western Reserve University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SOM-029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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