An interventional study of The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. in Reduction of Initial AHI and Reduction of Initial Snoaring Index, sponsored by Medartis AG. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-13.
Sponsored by Medartis AG · Not applicable, Interventional, and Treatment
Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
The new OSAS Implant is intended for use in the palate (hard and soft palate/ see picture above) in order to stiffen and stabilize the soft palate, which may reduce the severity of airway obstructions and of snoring in patients suffering from OSA (Obstructive Sleep Apnea). Indications for use of the System include: symptomatic, habitual, social snoring due to palatal flutter or upper airway obstruction primarily caused by the retropalatal obstruction. The System is labeled for use by physicians only.
The primary endpoint is the Apnea-Hypopnea-Index (AHI) in the 90 days follow-up.
Study hypothesis: Reduction of initial AHI ≥20%
Medartis AG is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Study patients must meet all of the following inclusion criteria:
Exclusion Criteria:
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.
The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. Two implants are placed underneath the rostral part of the palatal bone and continue into the upper part of the soft palate .
Device: The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.
The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. Two implants are placed underneath the rostral part of the palatal bone and continue into the upper part of the soft palate
Reduction of initial AHI by ≥20%
The primary endpoint is the Apnea-Hypopnea-Index (AHI) at the 90 days follow-up. Study hypothesis: Reduction of initial AHI ≥20%. AHI is measured using cardio-respiratory polygraphy. Two measurements are performed before treatment and at 90 days follow-up in order to reduce effects from night-to-night variability.
Time frame: 90days
Reduction of initial snoring index ≥30%
Endpoint snoring is measured on a continuous Visual Analog Scale (VAS) by the bed partner. Study hypothesis: Reduction of initial snoring index ≥30%
Time frame: 90days
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Medartis AG