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

November 15, 2017 updated by: Sommetrics, Inc.

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"

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Alameda, California, United States, 94501
        • California Center for Sleep Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cNEP
continuous negative external pressure will be used nightly by all participants
Device: continuous negative external pressure
continuous negative external pressure will be applied to the anterior neck at night
Other Names:
  • cNEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in baseline apnea hypopnea index from baseline
Time Frame: End of Week 2 of home use
Reduction in apnea hypopnea index (AHI) from the baseline value of >50% and also <15/hr
End of Week 2 of home use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of adverse events
Time Frame: two week study period
Collection of adverse events
two week study period
Apnea hypopnea index, as measured by home sleep testing
Time Frame: two weeks
Comparison of AHI from home sleep testing in this study to those of the polysomnogram (PSG) in SOM-012
two weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical global impression of cNEP experience
Time Frame: end of week two of home use
Assessment of the tolerability of cNEP to the subject via a clinical global impression scale
end of week two of home use
Bed partner's views of cNEP via a clinical global impression scale
Time Frame: end of two weeks of home use
Determination of the bed partner's views of the subject using cNEP in the home setting using a clinical global impression scale
end of two weeks of home use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sommetrics, Inc.

Investigators

  • Principal Investigator: Jerrold Kram, MD, California Center for Sleep Disorders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

March 25, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOM-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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