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Auricular Neuromodulation for FESS
Sponsor: Icahn School of Medicine at Mount Sinai
Summary
In this blinded prospective randomized control trial the researchers will investigate the impact of cutaneous vagal nerve stimulation on surgical conditions in patients undergoing functional and ascorbic sinus surgery (FESS). The device is an externally placed vagal nerve stimulator. The device will be applied to participants after consent and induction of anesthesia. The study team will open the randomization envelope and if the participant is assigned to stimulation the device will be turned on. In the case that the participant is assigned to the control arm, the device will be set to sham. The device will remain on for 30 minutes and removed before entering the OR. Device will be reinserted in the recovery room for another 30 minutes.
Official title: Auricular Neuromodulation and Surgical Conditions During Functional Endoscopic Sinus Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-10-23
Completion Date
2025-06-18
Last Updated
2026-08-19
Healthy Volunteers
No
Interventions
Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System
The Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System is a single-use electrode placed on and around the ear which provides transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN).
Locations (1)
Mount Sinai Hospital
New York, New York, United States