Clinical trial NCT05754216: Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve
Official title: Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Head and Neck Cancer
Obstructive Sleep Apnea
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

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)

Primary outcomes:
measure: Change in variation in the conformation of the glossopharyngeal nerve
timeFrame: Collected during a single operative procedure, taking about 15 minutes.
Secondary outcomes:
measure: Change in Airway cross-sectional diameter
timeFrame: Collected during a single DISE procedure, taking about 15 minutes.
measure: Change in airflow
timeFrame: Collected during a single DISE procedure, taking about 15 minutes.
measure: Change in upper airway pressure
timeFrame: Collected during a single DISE procedure, taking about 15 minutes.
measure: Change in respiratory effort
timeFrame: Collected during a single DISE procedure, taking about 15 minutes.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David T. Kent
role: STUDY_DIRECTOR
References: