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

Sommetrics

Status: Withdrawn

Conditions: Obstructive Sleep Apnea

Treatments: Device: continuous negative external pressure

Study type: Interventional

Funder types: Industry

Identifiers

NCT03108417

SOM-013

Details and patient eligibility

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.

Sex: All

Ages: 22 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

cNEP

Experimental group

Description:

continuous negative external pressure will be used nightly by all participants

Treatment:

Device: continuous negative external pressure