COMPLETED

Auricular Neuromodulation for FESS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-10-23
Study Completion:2025-06-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06662422

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ASA 1 and 2
  2. * Presenting for elective FESS surgery
  1. * Anti-fibrinolytic use within 30 days of enrollment
  2. * Known or acquired coagulation disorders
  3. * Hypercoagulable state, including morbid obesity and active smoking
  4. * Pregnancy
  5. * Blood transfusion with 30 days of enrollment
  6. * History of epileptic seizures
  7. * Presence of device such as pacemaker, cochlear prosthesis, neurostimulator
  8. * Ear infection
  9. * Abnormal ear anatomy which inhibits application of device
  10. * Presence of other significant disease or disorder which under the discretion of the principal investigator could influence the results of the trial or the participant's ability to participate in the trial

Contacts and Locations

Principal Investigator

Daniel Katz, MD
PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL

Study Locations (Sites)

Mount Sinai Hospital
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Daniel Katz, MD, PRINCIPAL_INVESTIGATOR, MOUNT SINAI HOSPITAL

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-23
Study Completion Date2025-06-18

Study Record Updates

Study Start Date2024-10-23
Study Completion Date2025-06-18

Terms related to this study

Keywords Provided by Researchers

  • blood loss
  • postoperative pain
  • Functional Endoscopic Sinus Surgery
  • Vagal Nerve Stimulation
  • Platelet Activation

Additional Relevant MeSH Terms

  • Functional Endoscopic Sinus Surgery
  • Vagal Nerve Stimulation
  • Platelet Activation