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| Name | Class |
|---|---|
| Adelaide Institute for Sleep Health, Flinders University | UNKNOWN |
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This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypoglossal nerve stimulation | Experimental | Device-mediated stimulation of the hypoglossal nerve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoglossal nerve stimulation | Device | Device stimulation of the hypoglossal nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target identification and access outcomes | Identification of and access to the target stimulation location aligned with the medial branch of the Hypoglossal Nerve | Day 0 |
| Tongue protrusion outcomes | Visual verification of protrusion of the tongue during stimulation at the target stimulation location with a representative electrode array. | Day 0 |
| Characterization of lead placement outcomes | Spatial characterization of the orientation of the electrode array and lead body to the target stimulation location considering suitable chronic anchoring locations. | Day 0 |
| Lead placement and removal outcomes | To demonstrate the ability to safely place and remove the electrode array, per protocol instructions. | Day 0 |
| Safety outcomes | To evaluate and report all observed adverse events, serious adverse events, unanticipated adverse events and adverse device effects observed during the study | Day 30 |
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Inclusion Criteria:
Subject must be eligible for a diagnostic or surgical procedure and
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide Institute for Sleep Health, Flinders University | Adelaide | South Australia | 5042 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40921399 | Result | Osman AM, Carney AS, Ooi EH, Joshi H, Toson B, Tran C, Hudson AL, Nguyen P, Gelekis N, Eastwood PR, Catcheside P, Eckert DJ. Effect of Novel Hypoglossal Stimulation on Airflow and Airway Collapsibility in OSA. Chest. 2026 Jan;169(1):257-268. doi: 10.1016/j.chest.2025.08.020. Epub 2025 Sep 6. |
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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 |
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| D020920 |
| Dyssomnias |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |