Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve

Trial Title: Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve

NCT ID: NCT05754216

Condition: Head and Neck Cancer
Obstructive Sleep Apnea

Conditions: Official terms:
Sleep Apnea, Obstructive

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

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.

Primary purpose: Basic Science

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Nerve stimulation using nerve stimulation device and sterile wire electrode.
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.
Arm group label: Surgical Procedure

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.

Criteria for 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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Vanderbilt University Medical Center

Address:
City: Nashville
Zip: 37232
Country: United States

Start date: December 2024

Completion date: March 2027

Lead sponsor:
Agency: Vanderbilt University Medical Center
Agency class: Other

Source: Vanderbilt University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05754216