Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial
| Status: | Withdrawn |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 22 - 70 |
| Updated: | 11/19/2017 |
| Start Date: | October 2017 |
| End Date: | September 2018 |
Home Study of Subjects With Obstructive Sleep Apnea Who Have Previously Completed an In-Lab Continuous Negative External Pressure (cNEP) Titration and Were Considered to be "Responders"
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.
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.
Inclusion Criteria:
- must have completed study SOM-012 and been categorized as a "responder"
- the subject agrees to participation by signing an informed consent statement
Exclusion Criteria:
- 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
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