Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea

Sommetrics

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: cNEP

Study type: Interventional

Funder types: Industry

Identifiers

NCT03375905

SOM-014

Details and patient eligibility

About

The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• both parents ethnically Japanese, or one parent Japanese and the other east-Asian
• PSG (polysomnogram) done within the previous 12 months that shows an AHI of 10-50/hr and <80% of apneas and hypopneas are obstructive
• cNEP collar fits and is well-tolerated

Key exclusion Criteria:

• BMI >34
• abnormalities in neck structure
• sleep disturbance other than obstructive sleep apnea
• serious medical illness
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

cNEP

Experimental group

Description:

cNEP treatment

Treatment:

Device: cNEP