Head and Neck Cancer, Obstructive Sleep Apnea
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
All patients who meet eligibility will undergo uni- or bilateral neck dissection and other indicated procedures for management of head and neck cancer and will have measurements and photos/videos of the common trunks taken. An electrode will be placed on one or both common trunks to stimulate infrahyoid muscles.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient (≥18 years old). * Scheduled for uni- or bilateral neck dissection (BND) for cervical lymphadenectomy of level IV and other indicated procedures for management of head and neck cancer.
Exclusion criteria
* Unable to consent for research due to a pre-existing neurologic condition as determined by PI. * Unable to consent for research due to language barriers. * History of prior neck surgery with transection of the infrahyoid strap muscles as determined by clinical history.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | Collected during a single operative procedure, taking about 15 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Objective | Collected during a single operative procedure, taking about 15 minutes. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid T. Kent, MD
Vanderbilt University Medical Center
Outcome results
None listed