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| Name | Class |
|---|---|
| University College London Hospitals | OTHER |
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This proof-of-concept study will evaluate the impact of surgically placing and stimulating the hypoglossal nerve and/or a second neural target Ansa Cervicalis, with a set of off-the-shelf electrode arrays.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypoglossal nerve and/or Ansa Cervicalis stimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoglossal nerve and/or Ansa Cervicalis stimulation | Device | Device stimulation of the hypoglossal nerve and/or Ansa Cervicalis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of participants with changes in cross-sectional area airway opening during target stimulation | Assessment of patients with changes in acute cross-sectional area airway opening measured in cm2 under nasoendoscopy when stimulating two neural targets (the HGN and AC). Video imaging and physician interpretation of nasoendoscopic images will be used to review outcome measures. | Day 0 |
| Assessment of changes in airflow outcomes | Assessment of acute changes in airflow when stimulating the HGN in combination with the AC during a flow limited event (hypopnea or apnea). | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participant adverse events observed during the study | To evaluate and report all observed participant adverse events observed during study. | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospital | London | NWI 2PG | United Kingdom |
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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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