Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndr… (NCT03640793) | Clinical Trial Compass
CompletedNot Applicable
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)
Switzerland25 participantsStarted 2017-10-09
Plain-language summary
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): A Pilot Study.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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