Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation

NCT05650710 | Completed FDA Device

• 1 other identifier: 221998
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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.

  Collected during a single operative procedure, taking about 15 minutes

Secondary Outcomes (2)

• Secondary Objective

  Collected during a single operative procedure, taking about 15 minutes.

• Secondary Objective

  Collected during a single operative procedure, taking about 15 minutes.

Study Arms (1)

Surgical Procedure

OTHER

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.

Interventions

Nerve stimulation using nerve stimulation device and sterile wire electrode. DEVICE

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.

Surgical Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• David T. Kent, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Otolaryngology-Head and Neck Surgery

Model Details: 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.

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: February 28, 2023
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: August 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)