Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial

Withdrawn before enrolling · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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 weeks in a home setting. It will also be determined whether two weeks of home use of cNEP is associated with any adverse events.

Key facts

Study ID

NCT03108417

Run by

Sommetrics, Inc.

People needed

0

Starts

2017-10-01

Expected to finish

2018-09-01

Last updated by the study team

2017-11-17

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• must have completed study SOM-012 and been categorized as a "responder"
• the subject agrees to participation by signing an informed consent statement

You may not qualify if…

• medical or social circumstances have changed since participation in SOM-012 such that continued use of cNEP may provide questionable benefit or associated with increased risk

Where it is running

• California Center for Sleep Disorders — Alameda, California, United States

Full record on ClinicalTrials.gov

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