An interventional study of Nerve stimulation using nerve stimulation device and sterile wire electrode. in Head and Neck Cancer and Obstructive Sleep Apnea, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Basic science
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.
This is a single-arm physiology study. Consenting patients undergoing neck dissection (ND) for cervical lymphadenectomy of level IV will undergo dissection of the ansa cervicalis nerves to the infrahyoid strap muscles. Per routine care, a large incision is made across the neck to provide surgeons access to the cervical lymph nodes for extirpation. During this dissection, the branch(es) of the ansa cervicalis nerve plexus descending from the loop of the plexus and innervating the infrahyoid strap muscles (the "common trunk") are dissected uni- or bilaterally. For this study, measurements and photos/videos of the common trunks will be taken. An electrode will be placed on one or both common trunks to stimulate infrahyoid muscles.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 51 is close to the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
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Exclusion Criteria:
Consented 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.
Device: Nerve stimulation using nerve stimulation device and sterile wire electrode.
A 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.
Primary Objective
Anatomic measurements of the length, diameter, and comformation of the common trunk of the ansa cervicalis to the sternothyroid muscle and it's dependent branches, measured in mm with a flexible ruler.
Time frame: Collected during a single operative procedure, taking about 15 minutes
Secondary Objective
The amount of caudal movement of the thyroid cartilage and hyoid bone with stimulation of the common trunk of the ansa cervicalis to the sternothyroid muscle and it's dependent branches, measured in mm with a flexible ruler.
Time frame: Collected during a single operative procedure, taking about 15 minutes.
Secondary Objective
Anatomic confirmation of the common trunk of the ansa cervicalis to the sternothyroid muscle and it's dependent branches, documented with photography.
Time frame: Collected during a single operative procedure, taking about 15 minutes.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Vanderbilt University Medical Center