Reduction of Initial AHI Clinical Trial
Official title:
Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
The new OSAS Implant is intended for use in the palate (hard and soft palate/ see picture above) in order to stiffen and stabilize the soft palate, which may reduce the severity of airway obstructions and of snoring in patients suffering from OSA (Obstructive Sleep Apnea). Indications for use of the System include: symptomatic, habitual, social snoring due to palatal flutter or upper airway obstruction primarily caused by the retropalatal obstruction. The System is labeled for use by physicians only. The primary endpoint is the Apnea-Hypopnea-Index (AHI) in the 90 days follow-up. Study hypothesis: Reduction of initial AHI ≥20% ;