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

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

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

Study Overview

• Status: Completed
• Conditions: Snoring; Obstructive Sleep Apnea
• Intervention / Treatment: Device: Implantation

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel Land
    • Basel, Basel Land, Switzerland, 4410
      • Kantonsspital Liestal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medartis AG
• Investigators: Principal Investigator: Kurt Tschopp, MD, Kantonsspital Liestal

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): February 13, 2024
• Study Completion (Actual): March 4, 2024

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Snoring, Obstructive Sleep Apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Respiratory Sounds; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Snoring
• Other Study ID Numbers: P15214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No