Clinical trial NCT03640793: Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Snoring
Obstructive Sleep Apnea
Keywords: Snoring, Obstructive Sleep Apnea
Lead sponsor: Medartis AG
Sponsor class: INDUSTRY
First posted: 2018-08-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single center, prospective, non-randomized, and non-blinded study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: AHI reduction
timeFrame: 3 months post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Kantonsspital Liestal
state: Basel Land
Study officials:
affiliation: Kantonsspital Liestal
name: Kurt Tschopp, MD
role: PRINCIPAL_INVESTIGATOR
References: