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Behavioural Intervention

Auricular Neuromodulation for Sinus Surgery

N/A
Recruiting
Led By Daniel Katz, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presenting for elective FESS surgery
Be older than 18 years old
Must not have
Known or acquired coagulation disorders
History of epileptic seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes after procedure

Summary

"This trial will test the effects of vagal nerve stimulation on surgical conditions in patients undergoing sinus surgery. Participants will have a device placed on their vagal nerve before surgery, which will either be turned on

Who is the study for?
This trial is for healthy individuals (ASA 1 and 2) scheduled for elective sinus surgery (FESS). It's not open to those with pacemakers, cochlear implants, neurostimulators, clotting disorders, obesity, smokers, pregnant women, recent blood transfusions or anti-fibrinolytic drug use, ear infections or abnormalities.
What is being tested?
The study tests the Sparrow Ascent tAN System's effect on surgical conditions during FESS. Participants are randomly chosen to receive either real vagal nerve stimulation or a sham treatment before and after surgery while under anesthesia.
What are the potential side effects?
Potential side effects may include discomfort at the device application site on the ear. Since it involves electrical stimulation of nerves near the skin surface there could be risks related to nerve irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for elective sinus surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a blood clotting disorder.
Select...
I have a history of epileptic seizures.
Select...
My ear shape prevents me from using certain devices.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes after procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes after procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Boezaart Score
Secondary study objectives
Post-operative nausea score
Post-operative vomiting score
Visual Analog Scale (VAS) for Post-operative pain score

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ElectrostimulationExperimental Treatment1 Intervention
Device will be turned on to send electrostimulation.
Group II: Sham - no electrostimulationPlacebo Group1 Intervention
Device will be toggled to Sham so no electrostimulation will be given.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
914 Previous Clinical Trials
570,779 Total Patients Enrolled
Daniel Katz, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
7 Previous Clinical Trials
919 Total Patients Enrolled
~60 spots leftby Mar 2025
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