Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05754216
Collaborator
(none)
50
1
1
24
2.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Nerve stimulation using nerve stimulation device and sterile wire electrode.
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All patients who meet eligibility will undergo a planned resection of parapharyngeal space (PPS) mass for management of head and neck cancer and will have measurements and photos/videos of the common trunks taken. 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.All patients who meet eligibility will undergo a planned resection of parapharyngeal space (PPS) mass for management of head and neck cancer and will have measurements and photos/videos of the common trunks taken. 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.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Surgical Procedure

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 pharyngeal musculature in a therapeutic manner.

Outcome Measures

Primary Outcome Measures

  1. Change in variation in the conformation of the glossopharyngeal nerve [Collected during a single operative procedure, taking about 15 minutes.]

    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.

Secondary Outcome Measures

  1. Change in Airway cross-sectional diameter [Collected during a single DISE procedure, taking about 15 minutes.]

    Change in airway cross-sectional diameter will be measured throughout the operative procedure via flexible fiberoptic nasopharyngoscopy.

  2. Change in airflow [Collected during a single DISE procedure, taking about 15 minutes.]

    Airflow (L/min) will be measured throughout the operative procedure via a pneumotachometer applied to the nose.

  3. Change in upper airway pressure [Collected during a single DISE procedure, taking about 15 minutes.]

    Upper airway pressure changes (cmH20) will be measured throughout the operative procedure via a pneumotachometer applied to the nose.

  4. Change in respiratory effort [Collected during a single DISE procedure, taking about 15 minutes.]

    Respiratory effort data (mV) will be measured throughout the operative procedure via two respiratory inductance plethysmography belts.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center Nashville Tennessee United States 37232

Sponsors and Collaborators

  • Vanderbilt University Medical Center

Investigators

  • Study Director: David T. Kent, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Kent, Associate Professor, Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT05754216
Other Study ID Numbers:
  • 230171
First Posted:
Mar 3, 2023
Last Update Posted:
Mar 3, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2023