cNEP for the Treatment of Obstructive Sleep Apnea

Continuous Negative External Pressure (cNEP) for the Treatment of Obstructive Sleep Apnea (OSA)

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

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