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Sleep Apnea, Obstructive

cNEP for the Treatment of Obstructive Sleep Apnea

Sponsored by Sommetrics, Inc.

About this trial

Last updated 7 years ago

Study ID

SOM-015

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial about?

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

What are the Participation Requirements?

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

Locations

Location

Status