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:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT06977503
Eligibility Criteria:
Inclusion Criteria:
* Age 21 ≤ and ≤ 75 years old
* Patient-facing healthcare workers (e.g., medical doctor, advanced practice provider, nurse)
* Experiencing symptoms of burnout, as defined by a score of 1, 2, or 3 on question #2 of the Mini-Z II Survey
* Working on the Buffalo-Niagara Medical Campus (e.g. Roswell Park, Oishei Children's Hospital, Buffalo General, etc.)
* Ability to attend three (3) in-person appointments, one (1) hour in duration, at Roswell Park at week 1, week 6 and week 12 corresponding to the initial, midpoint, and final assessments
* Ability to use the CES daily for an hour each day
* Although the device is water-resistant, participants must agree to not use the device in the bath or shower
* Ability to read and write in English
* Participant has access to a computer with internet access and an email address
* Ability to attend three (3) virtual 60-minute group life coaching sessions, via Zoom
* Ability to complete three (3) 10-15-minute pre-recorded video assignments, which will be distributed via email (each assignment will be due by the end of the week that they are distributed)
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
* Subjects who self-report as pregnant or nursing. Pregnancy be verified with a urine test for all persons of childbearing potential with a uterus
* Subjects with a self-reported history of the following: Meniere's disease, history of vertigo or prone to dizziness, seizure disorder, pacemaker / implantable cardioverter-defibrillator (automatic implantable cardioverter defibrillator \[AICD\]), cochlear implant, or any implanted electrical devices that cannot be shut off
* Inability to tolerate the required minimum stimulation amplitude (200 uA) during the initial device training at the baseline visit.
* Any self-reported medical or psychiatric condition which in the PI or study physician's opinion deems the participant an unsuitable candidate to participate in this trial.
* Unwilling or unable to follow protocol requirements
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT06977503
Study Brief:
Protocol Section:
NCT06977503