An interventional study of Implantation in Snoring and Obstructive Sleep Apnea, sponsored by Medartis AG. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Medartis AG · Not applicable, Interventional, and Treatment
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): A Pilot Study.
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.
122 studies on the registry are indexed under Snoring; 15 are open to participants now.
This study's enrollment of 25 is below the median of 43 across 95 interventional studies indexed under Snoring.
Browse Snoring studies →Medartis AG is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Socially disturbing snoring and obstructive sleep apnea syndrome with AHI≥10/h
Exclusion Criteria:
Previous Pillar implants
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implantation of 6 PPIS implants in each patient
Device: Implantation
Implantation of 6 PPIS implants
AHI reduction
AHI reduction
Time frame: 3 months post-op
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Feb 2024, 76 months.
Of 45 interventional studies with no phase under Snoring, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 31. This study's 76 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Medartis AG