The research team will evaluate pupillary dilation from vagal nerve stimulation of Arnold's Nerve, a branch of the vagus nerve, during routine cochlear implantation surgery.

The objective of this study is to determine if electrical stimulation of Arnold's Nerve, a branch of the vagus nerve, can result in vagal nerve response through the measurement of pupillary dilation

Inclusion Criteria:

Patients undergoing cochlear implantation:

• will be undergoing surgery for a cochlear implant
• is over the age of 18
• is willing to participate in the study

Patients undergoing vagal nerve stimulator implantation:

• will be undergoing implantable vagal nerve stimulation
• is over the age of 18
• is willing to participate in the study

Exclusion Criteria:

Patients undergoing cochlear implantation:

• is under the age of 18

• has history of prior ear surgery, congenital ear malformation, or cochlear implantation

• pregnant or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.

• medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following:

  • One vagus nerve
  • Receiving other concurrent forms of brain stimulation
  • Heart arrhythmias or other heart abnormalities
  • Dysautonomias (abnormal functioning of the autonomic nervous system)
  • Lung diseases or disorders (shortness of breath, asthma, etc.)
  • Ulcers (gastric, duodenal, etc.)
  • Vasovagal syncope (fainting)
  • Pre-existing hoarseness

Patients undergoing vagal nerve stimulator implantation:

• is under the age of 18

• has history of prior ear surgery, congenital ear malformation, or cochlear implantation

• pregnant or breastfeeding

• medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following:

  • One vagus nerve
  • Receiving other concurrent forms of brain stimulation
  • Heart arrhythmias or other heart abnormalities
  • Dysautonomias (abnormal functioning of the autonomic nervous system)
  • Lung diseases or disorders (shortness of breath, asthma, etc.)
  • Ulcers (gastric, duodenal, etc.)
  • Vasovagal syncope (fainting)
  • Pre-existing hoarseness

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: justin.cottrell@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to justin.cottrell@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.