Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)

Study Overview
=================
Brief Summary
-----------------
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): A Pilot Study.

Detailed Description
-----------------
The clinical study is designed as single center, prospective, non-randomized and non-blinded clinical study. Since the surgical procedure is independent of the population a single center study is applied. A double-blind study is not possible considering the implantation procedure with the surgeon always knowing if the device is set. Therefore, the study is designed to be non-randomized and non-blinded as a pilot trial. To reduce bias and other influences of single surgeon skills a principal investigator and one investigator are part of the clinical study. Further, subjects with previous treatments such as Pillar implant or previous airway surgery other than nasal, adenoid, tonsil or UPPP are excluded from the clinical study. A double-blind study is not possible considering the implantation procedure with the surgeon always knowing if the device is set. Therefore, the study is designed to be non-randomized and non-blinded as a pilot trial.

Official Title
-----------------
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): a Pilot Study

Conditions
-----------------
Snoring, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Socially disturbing snoring and obstructive sleep apnea syndrome with AHI≥10/h Predominantly retropalatal obstructions established either by: Drug-induced sedation nasendoscopy or ApneaGraph ≥60% (optional) or successful application of the Velumount palatal device (optional) Findings for predominantly retropalatal obstructions in ENT-examination: No tonsils or tonsils grade I Normal finding of larynx and tongue base, no omega-shaped epiglottis No lingual tonsil hypertrophy ASA (American Society of Anaesthesiology, 1963) classes I or II Body mass index (BMI) < 30 kg/m2 Age > 18 yrs Fix bed partner Ability to read and understand the patient's information Exclusion Criteria: • Previous Pillar implants Medartis palatinal implant (from previous phase I study) 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 Recurrent tonsillitis with prescription of antibiotics during the last 2 years (≥3x/year) Omega-shaped epiglottis Lingual tonsil hypertrophy Kinking of the internal carotid artery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single center, prospective, non-randomized, and non-blinded study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single center, prospective, non-randomized, non-blinded study<br>Implantation of 6 PPIS implants in each patient | Device: Implantation<br>* Implantation of 6 PPIS implants<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AHI reduction | AHI reduction | 3 months post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Snoring, Obstructive Sleep Apnea