[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05870527":3,"trial-entities:NCT05870527":81,"trial-summary:NCT05870527":84},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":42,"healthy_volunteers":15,"eligibility_criteria":43,"std_ages":63,"locations":66,"central_contacts":74,"overall_officials":75,"references":79,"see_also_links":80},"NCT05870527","23-00248","Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation","Single-Center Study of Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation","ENROLLING_BY_INVITATION","2026-06","2026-01","2026-01-28","2023-07-10","NYU Langone Health","OTHER",false,"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",[19],"Hearing Loss",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},30,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Electrical stimulator","Electrical stimulation will be used to stimulate the Arnold's nerve and measure pupil dilation. The electrical stimulator is part of the standard facial nerve monitoring unit that we utilize in cochlear implantation and will be setup prior to surgery in standard fashion. The device allows for constant current stimulation, with stimulus range between 0-30 mA.",[33],"Vagal Nerve Stimulation during Cochlear Implantation Surgery",[35],{"measure":36,"description":37,"timeFrame":38},"Pupillary Dilation during Procedure","Pupillary dilation (mm) measured via non-invasive pupillary measurement camera.","Day 1 (During procedure - typically 1 hour in duration)",[],"ALL","18 Years",null,{"inclusion":44,"exclusion":49,"raw_text":62},[45,46,47,48,46,47],"will be undergoing surgery for a cochlear implant","is over the age of 18","is willing to participate in the study","will be undergoing implantable vagal nerve stimulation",[50,51,52,53,54,55,56,57,58,59,60,50,51,61,53,54,55,56,57,58,59,60],"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.","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","pregnant or breastfeeding","Inclusion Criteria:\n\nPatients undergoing cochlear implantation:\n\n* will be undergoing surgery for a cochlear implant\n* is over the age of 18\n* is willing to participate in the study\n\nPatients undergoing vagal nerve stimulator implantation:\n\n* will be undergoing implantable vagal nerve stimulation\n* is over the age of 18\n* is willing to participate in the study\n\nExclusion Criteria:\n\nPatients undergoing cochlear implantation:\n\n* is under the age of 18\n* has history of prior ear surgery, congenital ear malformation, or cochlear implantation\n* pregnant or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.\n* medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following:\n\n  * One vagus nerve\n  * Receiving other concurrent forms of brain stimulation\n  * Heart arrhythmias or other heart abnormalities\n  * Dysautonomias (abnormal functioning of the autonomic nervous system)\n  * Lung diseases or disorders (shortness of breath, asthma, etc.)\n  * Ulcers (gastric, duodenal, etc.)\n  * Vasovagal syncope (fainting)\n  * Pre-existing hoarseness\n\nPatients undergoing vagal nerve stimulator implantation:\n\n* is under the age of 18\n* has history of prior ear surgery, congenital ear malformation, or cochlear implantation\n* pregnant or breastfeeding\n* medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following:\n\n  * One vagus nerve\n  * Receiving other concurrent forms of brain stimulation\n  * Heart arrhythmias or other heart abnormalities\n  * Dysautonomias (abnormal functioning of the autonomic nervous system)\n  * Lung diseases or disorders (shortness of breath, asthma, etc.)\n  * Ulcers (gastric, duodenal, etc.)\n  * Vasovagal syncope (fainting)\n  * Pre-existing hoarseness",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":13,"city":68,"state":68,"zip":69,"country":70,"geoPoint":71},"New York","10016","United States",{"lat":72,"lon":73},40.71427,-74.00597,[],[76],{"name":77,"affiliation":13,"role":78},"J. Thomas Roland Jr.","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":82,"biomarkers":83},[19],[],{"nct_id":4,"found":15,"summary":42,"prompt_version":42}]