cNEP for the Treatment of Obstructive Sleep Apnea (cNEP)

April 17, 2018 updated by: Sommetrics, Inc.

Continuous Negative External Pressure (cNEP) for the Treatment of Obstructive Sleep Apnea (OSA)

The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4P 1P2
        • Toronto Sleep Institute

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • PSG performed within the previous twelve months that documents the presence of obstructive sleep apnea (the "qualifying PSG")
  • on that PSG, AHI must be 10 - 50/hr and >80% of the apneas and hypopneas must be obstructive
  • no significant changes in health, medications, or lifestyle since the qualifying PSG

Key Exclusion Criteria:

  • previous major surgery, injury or radiation to the neck
  • beard or excessive hair on the area of the neck where the collar will be applied
  • carotid artery disease
  • serious medical conditions
  • pregnancy
  • use of home oxygen
  • silicone allergy
  • sleep disturbance other than obstructive sleep apnea

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
Subjects with OSA will be treated with cNEP (continuous negative external pressure) at home for three weeks
Device: cNEP
continuous negative external pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II
Time Frame: three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I
A response (either initial or sustained) is defined as an AHI that is < 50% of the qualifying PSG (polysomnography) that is also < 15/hr
three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I
occurrence of adverse events
Time Frame: three weeks
Adverse events that occur during the three weeks of cNEP home use.
three weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Initial Response" of AHI at PSG I
Time Frame: up to 12 months after the qualifying PSG
An AHI (apnea hypopnea index) that is <50% of that of the qualifying PSG, and <15/hr at PSG I, with cNEP in place.
up to 12 months after the qualifying PSG
Comparison of AHI at PSG I and PSG II
Time Frame: three weeks
The AHI determined at PSG II will be compared with that of PSG I
three weeks
time of SpO2 (oxygen saturation) < 90%
Time Frame: during each of the overnight PSGs
the number of minutes during the overnight PSG when SpO2 is < 90% with cNEP in place
during each of the overnight PSGs
hours of home use of cNEP per night
Time Frame: three weeks after initiation of home cNEP
the number of hours of each night at home that the subject uses cNEP
three weeks after initiation of home cNEP
Three CGI (clinical global impression) subjective measures
Time Frame: three weeks after the initiation of home cNEP
Seven-item Likert CGI scales of three subjective measures: 1) subject's view of cNEP vs CPAP, 2) overall satisfaction with cNEP, 3) bed partner's feelings about cNEP.
three weeks after the initiation of home cNEP

Collaborators and Investigators

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

Sponsor

Sommetrics, Inc.

Investigators

  • Principal Investigator: Adam Blackman, MD, Toronto Sleep Institute

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

May 1, 2016

Primary Completion (Actual)

November 3, 2017

Study Completion (Actual)

November 3, 2017

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOM-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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