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

Pilot Study to Evaluate the Effectiveness and Safety of the aerSleep™ System in an Ethnic Japanese Population Diagnosed With Obstructive Sleep Apnea (OSA)

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.

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