Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation
Part of paid clinical trials in Nashville, Tennessee.
- Sponsor
- Vanderbilt University Medical Center
- Study ID
- NCT05650710
- Status
- Recruiting
Conditions
- Head and Neck Cancer
- Obstructive Sleep Apnea
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nerve stimulation using nerve stimulation device and sterile wire electrode. — DEVICEA nerve stimulator device will be used in this study as a research tool to investigate whether a future (currently nonexistent) medical device might be able to stimulate desired infrahyoid musculature in a therapeutic manner.
Study Details
Recently published data suggest that stimulation of the infrahyoid strap muscles increases pharyngeal patency in patients with obstructive sleep apnea, but the innervation of these muscles by the ansa cervicalis is variable. The investigators propose a study examining the anatomic variation of the ansa cervicalis and the effect of neurostimulation on muscle recruitment.
Key Dates
- Start date
- Feb 28, 2023
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Other: Surgical ProcedureConsented patients who meet eligibility will have a surgical procedure for management of head and neck cancer, with dissection and exposure of the relevant anatomic structures as part of regular clinical care.
Primary Outcome Measure
Primary Objective [ Time Frame: Collected during a single operative procedure, taking about 15 minutes ]
Central Contacts
- Katie Hartley-Estes, RPSGT(615) 875-9214
- Nicole L Jones, MS615-936-2807
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | David T Kent, MD (PRINCIPAL_INVESTIGATOR) |
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