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

Medartis

Status: Completed

Conditions: Snoring; Obstructive Sleep Apnea

Treatments: Device: Implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03640793

P15214

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Single center, prospective, non-randomized, non-blinded study

Experimental group

Description:

Implantation of 6 PPIS implants in each patient

Treatment:

Device: Implantation