Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT03640793
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03640793
Study Brief:
Protocol Section:
NCT03640793