Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial
Sponsored by Sommetrics, Inc.
About this trial
Last updated 8 years ago
Study ID
SOM-013
Status
Withdrawn
Type
Interventional
Phase
N/A
Placebo
No
Accepting
22 to 70 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 7 years ago
What is this trial about?
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.
What are the participation requirements?
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