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

NCT ID: NCT03108417

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-31

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cNEP

continuous negative external pressure will be used nightly by all participants

Group Type EXPERIMENTAL

continuous negative external pressure

Intervention Type DEVICE

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

Interventions

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continuous negative external pressure

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

Intervention Type DEVICE

Other Intervention Names

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cNEP

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sommetrics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jerrold Kram, MD

Role: PRINCIPAL_INVESTIGATOR

California Center for Sleep Disorders

Locations

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California Center for Sleep Disorders

Alameda, California, United States

Site Status

Countries

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United States

Other Identifiers

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SOM-013

Identifier Type: -

Identifier Source: org_study_id