Study Using Negative Pressure to Reduce Apnea

NCT04861038 | Active Not Recruiting FDA Device

• 1 other identifier: SOM-029
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 15

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.

Conditions

Sleep Apnea, Obstructive; Apnea, Sleep

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Sustained response to aerSleep II therapy at 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

  The primary safety endpoint is to characterize the adverse device effects experienced throughout the study.

  24 weeks

Secondary Outcomes (5)

• ODI change

  24 weeks

• AHI change from baseline for all subjects that acclimate to 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

  24 weeks

• Change in sleep impairment from baseline as measured by PROMIS Sleep Sleep-Related Impairment questionnaire

  24 weeks

• Change in sleep from baseline as measured by Patient Global Impression Scale questionnaire

  24 weeks

Study Arms (1)

aerSleep II

EXPERIMENTAL

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

Interventions

aerSleep II DEVICE

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

aerSleep II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Body mass index ≤42 kg/m2
• Prior documented diagnosis of OSA by means of a polysomnography (PSG) test or home sleep test (HST)
• Documented evidence from a screening HST following consent to demonstrate:
• AHI 15 - 50/hour
• \>80% of the apneas and hypopneas are obstructive
• Previous treatment attempt with CPAP resulting in failure to treat or discontinuation due to intolerance, subject choice, or struggle to use CPAP
• 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
• Access to and ability to use a smart device such as a smartphone or tablet
• Able to speak, read, and write English
• In the opinion of the investigator, the subject will be able to understand and comply with all study procedures.

You may not qualify if:

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

Sponsors & Collaborators

• Sommetrics, Inc.: lead

Study Sites (15)

University of Arizona

Tucson, Arizona, 85719, United States

Location

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Infinitive Bioresearch

Los Angeles, California, 90048, United States

Location

BetterNight

San Diego, California, 92123, United States

Location

Delta Waves

Colorado Springs, Colorado, 80918, United States

Location

Baptist Hospital

Miami, Florida, 33176, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

The MetroHealth System

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Bogan Sleep Consultants

Columbia, South Carolina, 29201, United States

Location

BioSerenity

Columbia, South Carolina, 29212, United States

Location

Sleep Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kingman P. Strohl, M.D.

  Case Western Reserve University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: November 29, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)