Transcutaneous Vagus Nerve Stimulation (tVNS) for Improved Recovery After Exertion.

NANot yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 19, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Post-COVID-19 Syndrome
Interventions
DEVICE

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.

BEHAVIORAL

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.

DEVICE

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.

Trial Locations (1)

72076

Department of Psychiatry & Psychotherapy, University of Tübingen, Tübingen

All Listed Sponsors
lead

University Hospital Tuebingen

OTHER

NCT06510985 - Transcutaneous Vagus Nerve Stimulation (tVNS) for Improved Recovery After Exertion. | Biotech Hunter | Biotech Hunter