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| Name | Class |
|---|---|
| Hollywood Private Hospital | UNKNOWN |
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This Proof-of-Concept study will collect acute and sub-acute flow and/or AHI data following the placement of lead arrays under direct vision. The acute placement and data collection will be collected following the completion of the pre-scheduled neck dissection surgery. The sub-acute data will be collected in a sleep lab during a polysomnography (PSG). Both data collections will be done when stimulating (using an external pulse generator) the hypoglossal nerve or Genioglossus muscle (GG) and a second neural target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of Off-the-Shelf (OTS) electrode arrays.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Target stimulation | Experimental | Stimulation of a combination of targets: Hypoglossal nerve (HGN) and Ansa Cervicalis (AC), Genioglossus (GG) and AC, HGN and strap muscles, or GG and strap muscles, during an acute and sub-acute phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Target Stimulation (HGN, AC, GG, Strap muscles) | Device | Simulation of a combination of: HGN, AC, GG or strap muscles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Impacts on acute airway opening | Demonstration of acute airway opening as visually observed under nasoendoscopy when stimulating the HGN or GG and a second target (neural or direct muscle stimulation). | Day 0 to 3 |
| Impacts on airflow during a acute assessment | Acute increase in airflow when stimulating the HGN or GG and a second target (neural or direct muscle stimulation), measured by changes in amplitude (mA) during target stimulation. | Day 0 to 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Impacts on airway opening during a sub-acute assessment | Demonstration of sub-acute flow increase and/or AHI reduction when stimulating two targets simultaneously during natural sleep as measured with polysomnography (PSG), measured by polysomnography. | Day 0 to 3 |
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Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be eligible for inclusion in this study:
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded from participation in this study:
Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned.
Significant comorbidities that contraindicate surgery or general anesthesia.
Significant tongue weakness.
Aerodigestive tract tumor or reconstructive surgery performed at the same time as neck dissection.
Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:
Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery).
Prior hypoglossal nerve stimulation device implantation.
Currently pregnant or breastfeeding during the study period.
Concomitant oral or pharyngeal surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perth Head and Neck Surgery | Perth | Western Australia | 6009 | Australia |
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Electrode arrays placed adjacent to nerves are connected to an external pulse generator to evaluate the effect of short-term stimulation on airflow and/or AHI
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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