Evidence map›Paper›PMID 40773008›Full record

Trial reportEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2025

A novel palato-pharyngeal implant system for the treatment of snoring and obstructive sleep apnea.

Kurt Tschopp, Andreas Mullis, Christoph Knaus, Samuel Tschopp

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03640793 (Prospective Evaluation of a Palato-Pharyngeal Implant System), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03640793 nacompletednot on this map

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

TypeinterventionalSponsorMedartis AGRan2017 to 2024Enrolled25ConditionsSnoring, Obstructive Sleep ApneaArmsImplantation
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Kurt TschoppDepartment of Otorhinolaryngology, Head and Neck Surgery, Kantonsspital Baselland, Mühlemattstrasse 11, 4410, Liestal, Switzerland. kurt.tschopp@ksbl.ch.ORCID http://orcid.org/0000-0002-3679-5883
Andreas MullisMedartis AG, Basel, Switzerland.
Christoph KnausDepartment of Otorhinolaryngology, Head and Neck Surgery, Kantonsspital Baselland, Mühlemattstrasse 11, 4410, Liestal, Switzerland.
Samuel TschoppDepartment of Otorhinolaryngology, Head and Neck Surgery, Kantonsspital Baselland, Mühlemattstrasse 11, 4410, Liestal, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the safety and effectiveness of a minimally invasive nitinol-based palato-pharyngeal implant system (PPIS) stabilizing the lateral pharyngeal walls in patients with snoring and obstructive sleep apnea.

methodsThis first-in-man clinical trial of a minimally invasive nitinol-based PPIS comprised six implants. Twenty-four patients with socially disturbing snoring and obstructive sleep apnea were included. The primary endpoint was the Apnea-Hypopnea Index (AHI) reduction three months postoperatively. Secondary endpoints were the snoring intensity and general sleep quality, the Epworth Sleepiness Scale (ESS), and the Pittsburgh Sleep Quality Index (PSQI). Safety was assessed via implant extrusion and adverse event rates. Follow-up duration was five years.

resultsTwenty-four patients were implanted between November 2017 and November 2018 and followed until March 2024. At three months, median (IQR) AHI decreased modestly from 23/h (16-30) to 19/h (10-30). ESS decreased from 10 (6-13) to 5 (2-8), and the snoring index from 8 (8-9) to 4 (3-6). General sleep quality improved from 5.5 (4-8) to 2 (2-3), and PSQI from 6 (4.8-8) to 4 (2.8-5.2). All changes were statistically significant (p <.05). Improvements in patient-reported outcomes persisted over five years. The implants were well tolerated, with no reports of disturbing foreign body sensation. The extrusion rate was 6% (9/144 implants).

conclusionThis first-in-human clinical trial demonstrates that the PPIS is safe and well-tolerated. While a reduction in AHI was observed at three months postoperatively, the clinical significance of this reduction remains uncertain. Notably, the five-year follow-up indicates sustained and clinically meaningful improvements in patient-reported symptoms.

trial registrationClinicalTrials.gov Identifier NCT03640793.

Indexed as

PharynxProstheses and ImplantsProsthesis ImplantationSleep Apnea, ObstructiveSnoringAdultAgedAlloysFemaleHumansMaleMiddle AgedProsthesis DesignSleep QualityTreatment OutcomeAlloysnitinolImplantObstructive sleep apneaPalatal surgerySnoringUpper airway

Identifiers

PMID40773008

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.