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)

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%

Inclusion Criteria:

Study patients must meet all of the following inclusion criteria:

• Socially disturbing snoring with/without obstructive sleep apnea syndrome
• Predominantly retropalatal obstructions established by ApneaGraph ≥60%, sleep nasendoscopy or successful application of the Velumount palatal device
• Findings for predominantly retropalatal obstructions in ENT-examination:
• No tonsils or tonsils grade I - II
• Normal finding of larynx and tongue base
• No lingual tonsil hypertrophy
• ASA (American Society of Anaesthesiology, 1963) criteria I or II
• Body mass index (BMI) < 33 kg/m2
• Age > 18 yrs
• Fix bed partner
• Ability to read and understand the patient's information

Exclusion Criteria:

• Previous Pillar implants
• Previous airway surgery other than nasal, adenoid, tonsil or UPPP
• Presence of other sleep disorders
• Psychiatric disorders
• Neurological disorders (e.g. Cerebrovascular injury)
• Dysmorphia of the cranial skeleton
• Pregnancy or breastfeeding
• Known hypersensitivity to nitinol
• Participation in another clinical study