NCT03108417

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

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"

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sommetrics, Inc. · Industry
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	continuous negative external pressure	continuous negative external pressure will be applied to the anterior neck at night

Timeline

• Start date: 2017-10-01
• Primary completion: 2018-06-01
• Completion: 2018-09-01
• First posted: 2017-04-11
• Last updated: 2017-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study