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ACTIVE NOT RECRUITING
NCT04861038
NA

Study Using Negative Pressure to Reduce Apnea

Sponsor: Sommetrics, Inc.

View on ClinicalTrials.gov

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.

Official title: Study Using Negative Pressure to Reduce Apnea (SUPRA)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2021-11-29

Completion Date

2025-12

Last Updated

2024-04-16

Healthy Volunteers

No

Interventions

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

Locations (15)

University of Arizona

Tucson, Arizona, United States

Preferred Research Partners

Little Rock, Arkansas, United States

Infinitive Bioresearch

Los Angeles, California, United States

BetterNight

San Diego, California, United States

Delta Waves

Colorado Springs, Colorado, United States

Baptist Hospital

Miami, Florida, United States

Clayton Sleep Institute

St Louis, Missouri, United States

The MetroHealth System

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

Bogan Sleep Consultants

Columbia, South Carolina, United States

BioSerenity

Columbia, South Carolina, United States

Sleep Therapy & Research Center

San Antonio, Texas, United States