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Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve

Primary Purpose

Head and Neck Cancer, Obstructive Sleep Apnea

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nerve stimulation using nerve stimulation device and sterile wire electrode.
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Surgical Procedure

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Airway cross-sectional diameter
Change in airway cross-sectional diameter will be measured throughout the operative procedure via flexible fiberoptic nasopharyngoscopy.
Change in airflow
Airflow (L/min) will be measured throughout the operative procedure via a pneumotachometer applied to the nose.
Change in upper airway pressure
Upper airway pressure changes (cmH20) will be measured throughout the operative procedure via a pneumotachometer applied to the nose.
Change in respiratory effort
Respiratory effort data (mV) will be measured throughout the operative procedure via two respiratory inductance plethysmography belts.

Full Information

First Posted
February 13, 2023
Last Updated
September 19, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05754216
Brief Title
Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve
Official Title
Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical Procedure
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Nerve stimulation using nerve stimulation device and sterile wire electrode.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in variation in the conformation of the glossopharyngeal nerve
Description
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.
Time Frame
Collected during a single operative procedure, taking about 15 minutes.
Secondary Outcome Measure Information:
Title
Change in Airway cross-sectional diameter
Description
Change in airway cross-sectional diameter will be measured throughout the operative procedure via flexible fiberoptic nasopharyngoscopy.
Time Frame
Collected during a single DISE procedure, taking about 15 minutes.
Title
Change in airflow
Description
Airflow (L/min) will be measured throughout the operative procedure via a pneumotachometer applied to the nose.
Time Frame
Collected during a single DISE procedure, taking about 15 minutes.
Title
Change in upper airway pressure
Description
Upper airway pressure changes (cmH20) will be measured throughout the operative procedure via a pneumotachometer applied to the nose.
Time Frame
Collected during a single DISE procedure, taking about 15 minutes.
Title
Change in respiratory effort
Description
Respiratory effort data (mV) will be measured throughout the operative procedure via two respiratory inductance plethysmography belts.
Time Frame
Collected during a single DISE procedure, taking about 15 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David T. Kent
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve

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