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

NCT03640793 | Completed DMC

• 1 other identifier: P15214
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Snoring; Obstructive Sleep Apnea

Keywords

Snoring, Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• AHI reduction

  AHI reduction

  3 months post-op

Study Arms (1)

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

EXPERIMENTAL

Implantation of 6 PPIS implants in each patient

Device: Implantation

Interventions

Implantation DEVICE

Implantation of 6 PPIS implants

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medartis AG: lead

Study Sites (1)

Kantonsspital Liestal

Basel, Basel-Landschaft, 4410, Switzerland

Location

Related Publications (1)

• Tschopp K, Mullis A, Knaus C, Tschopp S. A novel palato-pharyngeal implant system for the treatment of snoring and obstructive sleep apnea. Eur Arch Otorhinolaryngol. 2025 Sep;282(9):4877-4885. doi: 10.1007/s00405-025-09545-z. Epub 2025 Aug 7.

  PMID: 40773008 DERIVED

MeSH Terms

Conditions

Snoring; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kurt Tschopp, MD

  Kantonsspital Liestal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center, prospective, non-randomized, and non-blinded study

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: August 21, 2018
• Study Start: October 9, 2017
• Primary Completion: February 13, 2024
• Study Completion: March 4, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)