Clinical trials: Negative Pressure Ventilation
Obstructive Sleep Apnea
Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial
This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two…
- Trial name
- NCT03108417
- Testing
- continuous negative external pressure
- Where
- United States
- Sponsor
- Sommetrics, Inc.
Airway Obstruction, Apnea
Effectiveness of Continuous Negative External Pressure in Preventing Upper Airway Impairment During Routine Colonoscopy
The primary goal of this study is to determine the effectiveness and safety of delivering continuous negative external pressure (cNEP) to the upper airway as a means of preventing episodes of respiratory impairment (RI) such as…
- Conditions
- Airway Obstruction, Apnea, Hypopnea
- Trial name
- NCT01895062
- Testing
- Airway Management System (AMS)
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- 5i Sciences, Inc.
Obstructive Sleep Apnea
Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study
Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary treatment for OSA. Negative external pressure, applied over the anterior neck under the mandible, has shown encouraging results as an…
- Trial name
- NCT04718142
- Testing
- vNEP
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Somne, LLC
Obstructive Sleep Apnea (OSA)
A Post-marketing Surveillance of the Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea
This is a post-marketing surveillance study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
- Trial name
- NCT02698059
- Testing
- iNAP® Sleep Therapy System (iNAP)
- Where
- 8 sites in Germany, Taiwan
- Volunteers
- 63 people
- Sponsor
- Somnics, Inc.
Obstructive Sleep Apnea, Sleep Apnea
Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial
The goal of this study is to allow continued access to the aerSleep II System for subjects that have completed the SOM-029 study until the device is commercially available.
- Trial name
- CO-STAR (NCT05608486)
- Testing
- aerSleep II
- Sponsor
- Sommetrics, Inc.
Obstructive Sleep Apnea
Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea
This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
- Trial name
- NCT02324790
- Testing
- iNAP® Sleep Therapy System
- Where
- 4 sites in Taiwan
- Volunteers
- 34 people
- Sponsor
- Somnics, Inc.
Sleep Apnea, Obstructive, Apnea, Sleep
Study Using Negative Pressure to Reduce Apnea
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…
- Trial name
- SUPRA (NCT04861038)
- Testing
- aerSleep II
- Where
- 15 sites in United States
- Volunteers
- 900 people
- Sponsor
- Sommetrics, Inc.
Sleep Apnea, Obstructive
cNEP for the Treatment of Obstructive Sleep Apnea
The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea
- Trial name
- cNEP (NCT02677168)
- Testing
- cNEP
- Where
- Canada
- Volunteers
- 71 people
- Sponsor
- Sommetrics, Inc.