SnoringNCT03640793
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)
A study testing Implantation in people with Snoring and Obstructive Sleep Apnea, run by Medartis AG at 1 site in Switzerland.
Trial summary
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): A Pilot Study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snoring, Obstructive Sleep Apnea
- What is being tested?
- Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Oct 2017to 4 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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:
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- 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
Who cannot join
- • 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
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
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): A Pilot Study.
Read the 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.
- Conditions
- Snoring, Obstructive Sleep Apnea
- Being tested
- Implantation
- Keywords
- Snoring, Obstructive Sleep Apnea
- Medical subject headings
- Snoring, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantationDevice
Implantation of 6 PPIS implants
| Study group | Role | What they receive |
|---|---|---|
| Single center, prospective, non-randomized, non-blinded study | Experimental | Implantation of 6 PPIS implants in each patient Receives: Device: Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI reduction
AHI reduction
Measured: 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start9 Oct 2017
- Primary completion13 Feb 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center, prospective, non-randomized, and non-blinded study
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medartis AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kurt Tschopp, MD, Principal investigator, Kantonsspital Liestal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640793
- Sponsor's protocol ID
- P15214
- Status last verified
- Mar 2024
- First submitted
- 26 Oct 2017
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40773008
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03640793
- Acronym / sponsor ID
- P15214
- Conditions
- Snoring, Obstructive Sleep Apnea
- Keywords
- Snoring, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medartis AGIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, prospective, non-randomized, and non-blinded study
| Arm | Type | Receives |
|---|---|---|
| Single center, prospective, non-randomized, non-blinded study | Experimental | Device: ImplantationImplantation of 6 PPIS implants in each patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- • Socially disturbing snoring and obstructive sleep apnea syndrome with AHI≥10/h
Key exclusion criteria (14 listed)
- • Previous Pillar implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImplantationImplantation of 6 PPIS implants | Device | Single center, prospective, non-randomized, non-blinded study |
Primary outcome
AHI reduction
Time frame: 3 months post-op
AHI reduction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 40773008Tschopp 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Tschopp, MD principal investigator
Kantonsspital Liestal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation in people with Snoring and Obstructive Sleep Apnea, run by Medartis AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AHI reduction (time frame: 3 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.