MedTrace Logo

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

NCT03108417 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-11-17

No results posted yet for this study

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

Interventions

DEVICE

continuous negative external pressure

continuous negative external pressure will be applied to the anterior neck at night

Sponsors & Collaborators

  • Sommetrics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jerrold Kram, MD · California Center for Sleep Disorders

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2018-06-30
Completion
2018-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03108417 on ClinicalTrials.gov