Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve

Head and Neck Cancer Clinical Trial

Official title:

Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05754216
• Other study ID #: 230171
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 2024
• Est. completion date: March 2026

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Published data suggest that the glossopharyngeal nerve innervates pharyngeal musculature important for maintenance of upper airway patency. The investigators propose a study examining the anatomic variation of the glossopharyngeal nerve and the effect of electrical stimulation on muscle recruitment and upper airway patency.

Description:

This is a single-arm physiology study. Consenting patients undergoing parapharyngeal space (PPS) surgery for tumor extirpation will undergo dissection of the glossopharyngeal nerve branches to the stylopharyngeus and pharyngeal constrictor muscles. Fine-wire electrodes will be placed on these nerve branches. For each patient, if the target nerve branches can be identified and electrodes successfully placed, they will additionally undergo drug-induced sleep endoscopy (DISE) immediately following PPS surgery. Per routine care, an incision is made across the neck to provide surgeons access to parapharyngeal space for tumor extirpation. During this dissection, the branch(es) of the glossopharyngeal nerve innervating the stylopharyngeus (SP) and pharyngeal constrictor (PC) muscles are exposed. For this study, measurements and photos/videos of the nerve will be taken. A fine-wire electrode will be placed on either or both successfully identified nerves and stimulated to assess muscle activation and changes in upper airway patency.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consenting adults with BMI = 25 and = 40 kg/m2
• Planned resection of parapharyngeal space (PPS) mass without clinical evidence of cranial nerve function deficits based on physical examination
• History of moderate-to-severe Obstructive Sleep Apnea (OSA) as confirmed by previous polysomnogram OR high risk for OSA based on STOP-BANG criteria (STOP-BANG score = 3)

Exclusion Criteria:

• Unable to consent for research due to a pre-existing neurologic condition or language barriers as determined by PI
• History of other primary sleep-related breathing disorder (e.g., central, or complex sleep apnea).
• Previous pharyngeal surgery excluding tonsillectomy (e.g. cleft palate repair, uvulopalatopharyngoplasty)
• Prior history of head and/or neck chemoradiation therapy
• Existing indwelling neurostimulation device (e.g. pacemaker; spinal, vagal, or hypoglossal nerve stimulator)

Related Conditions & MeSH terms

• Head and Neck Cancer
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

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 pharyngeal musculature in a therapeutic manner.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in variation in the conformation of the glossopharyngeal nerve	The natural variation in the conformation of the glossopharyngeal nerve will be measured by length, diameter, and conformation of the common trunk and its dependent branches to the Stylopharyngeus Muscle (SP) and Pharyngeal Constrictor Muscles (PC), measured in mm with a flexible ruler.	Collected during a single operative procedure, taking about 15 minutes.
Secondary	Change in Airway cross-sectional diameter	Change in airway cross-sectional diameter will be measured throughout the operative procedure via flexible fiberoptic nasopharyngoscopy.	Collected during a single DISE procedure, taking about 15 minutes.
Secondary	Change in airflow	Airflow (L/min) will be measured throughout the operative procedure via a pneumotachometer applied to the nose.	Collected during a single DISE procedure, taking about 15 minutes.
Secondary	Change in upper airway pressure	Upper airway pressure changes (cmH20) will be measured throughout the operative procedure via a pneumotachometer applied to the nose.	Collected during a single DISE procedure, taking about 15 minutes.
Secondary	Change in respiratory effort	Respiratory effort data (mV) will be measured throughout the operative procedure via two respiratory inductance plethysmography belts.	Collected during a single DISE procedure, taking about 15 minutes.