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

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT03375905

Run by

Sommetrics, Inc.

People needed

8

Starts

2017-12-07

Expected to finish

2019-04-26

Last updated by the study team

2019-09-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• The Sleep Lab — Kaneohe, Hawaii, United States

Full record on ClinicalTrials.gov

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