cNEP for the Treatment of Obstructive Sleep Apnea

NCT ID: NCT02677168

Last Updated: 2018-04-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-11-03

Brief Summary

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

Detailed Description

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Conditions

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Sleep Apnea, Obstructive

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

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

Group Type EXPERIMENTAL

cNEP

Intervention Type DEVICE

continuous negative external pressure

Interventions

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cNEP

continuous negative external pressure

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 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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Adam Blackman, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto Sleep Institute

Locations

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Toronto Sleep Institute

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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SOM-015

Identifier Type: -

Identifier Source: org_study_id

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