cNEP for the Treatment of Obstructive Sleep Apnea

Sommetrics

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Device: cNEP

Study type: Interventional

Funder types: Industry

Identifiers

NCT02677168

SOM-015

Details and patient eligibility

About

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

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

cNEP

Experimental group

Description:

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

Treatment:

Device: cNEP