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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%
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSAS Palatal Implant | Other | 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90days |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | 90days |
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Inclusion Criteria:
Study patients must meet all of the following inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Tschopp, MD | Kantonsspital Liestal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Liestal | Basel | Basel-Landschaft | 4410 | Switzerland |
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