120
Participants
Start Date
July 19, 2024
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2027
transcutaneous vagus nerve stimulation
The study employs a CE-certified tVNS® E device, ensuring European safety standards (EU regulation 2017/745 on medical devices). This device features a stimulation cycle of 28 seconds on and 32 seconds off, with a 25 Hz impulse frequency. For the high-intensity group, the stimulation intensity will be individually adjusted in the session before starting the high-intensity tVNS stimulation at home. Recommended daily usage is max. 4 hours, after which it automatically shuts off.
Monitoring
Participants are monitored over 12 weeks using a combination of questionnaires and ecological momentary assessment. This approach allows for a comprehensive assessment of the patient's health and well-being.
cardiowatch bracelet
The study employs the medically certified cardiowatch bracelet from Corsano (CE-MDR medical certification, FDA 510 (k) cleared) for continuous monitoring of vital signals, such as heart rate, heart rate variability, breathing rate, SpO2, physical activity and sleep.
Department of Psychiatry & Psychotherapy, University of Tübingen, Tübingen
University Hospital Tuebingen
OTHER