Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT05870527
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05870527
Study Brief:
Protocol Section:
NCT05870527