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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
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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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoglossal nerve stimulation | Device | Device-mediated stimulation of the hypoglossal nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification and access of the target outcomes | Consistent 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 electrode array 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 |
| Electrode array 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 an OSA diagnostic or surgical procedure.
Subject suffers with moderate to severe OSA based on history and a physical exam.
Subject has failed, refused or has not tolerated CPAP treatment.
Subject is willing and capable of providing informed consent.
Subject is willing to have a representative electrode array temporarily placed in the submandibular, sublingual and mylohyoid space.
--Subject is willing to participate in the designated follow-up visits.
Subject must be in good general health.
Subject is able to understand and has voluntarily signed and dated the IRB or EC approved informed consent form (ICF) prior to initiation of any screening or study-specific procedure.
Subject must be minimum of 21 years and maximum 80 years of age.
Subject's Hypoglossal Nerve must be able to be visualized using ultrasound
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt Bill Wilkerson Centre | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38943442 | Result | Kent DT, Li Y. Percutaneous Approaches to Hypoglossal Nerve Stimulation: A Pilot Study During Drug-Induced Sleep Endoscopy. Otolaryngol Head Neck Surg. 2024 Oct;171(4):1250-1253. doi: 10.1002/ohn.880. Epub 2024 Jun 29. |
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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 |