An interventional study of transcutaneous electrical vagal neurostimulation in Vagus Nerve Diseases, Long COVID and Long Covid19, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-06-26.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
The aim of the present pilot study is to investigate the acceptance, feasibility and implementation of the vagus nerv stimulation in Long COVID patients. Additionally, the effects on parameters of the autonomic nervous system as well as on symptoms of Long COVID will be described in a pre/post comparison.
For this purpose, a total of 45 female Long COVID patients will participate in the randomized controlled pilot study. Patients will perform auricular vagus stimulation daily for 12 weeks. The patient collective will be randomized into three groups (A: 10 hertz, B: 25 hertz, C: 2 hertz=control group).
If appropriate results are obtained, further adequately powered intervention studies are planned.
Patients start on day 0, when the first assessment takes place. This consists of a medical diagnostic interview and sociodemographic, anthropometric, medical and functional data are collected (for a detailed description, see chapter 5. Statistics). Subsequently, the patients fill out the given questionnaires (paper/pencil version), which are then evaluated. Subsequently, the test persons are trained by a doctor how the electrical stimulation works with a demo device. Finally, the device is taken over by the company Schwa-Medico. The whole first assessment lasts about 2 hours and always takes place from 8 a.m. at constant room temperature (22-23 C°).
The outcome parameters are recorded before the start of the vagus nerve stimulation (T0), during the treatment after 4 weeks (T0+4Wo) and after a total of 12 weeks (T0+12Wo) after the end of the therapy. Which assessments are collected at the different time points is listed in the biometry section. The assessments are performed by physicians of the Department of Physical Medicine, Rehabilitation and Occupational Medicine. All assessments take place at relatively the same time, at constant room temperature (22-23 C°). The patients have to appear fasting.
T0: Medical history, examination, randomization, pre-tests, enrollment. T0+4Wo: Intermediate examination T0+12Wo: final examination, post-tests, return of device
This pilot study investigates the acceptability, feasibility, and implementation of the VNS measure in Long COVID patients. In addition, effects on autonomic nervous system parameters (heart rate, blood pressure, rate pressure product, heart rate variability = HRV, cortisol in saliva), on symptoms fatigue, dyspnea as well as health-related quality of life (HRQOL) are described:
Time points: T0, T0+4wk, T0+12wk.
Parameters - collected at relatively the same time each day, at constant room temperature (22-23 C°):
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 45 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Twelve weeks home therapy with transcutaneous electrical neurostimulation (TENSeco®, CE197, Schwa-Medico Gmbh), transcutaneous 2-channel nerve stimulator. Matching ear electrode 3 DTS. * Stimulation frequency: 10 Hertz * Intensity: sensitive threshold; clearly perceptible, but pleasant * Form of stimulation: biphasic * Duration: 30 min * Position: left ear * Frequency: daily, in the evening, when all daily activities are done
Device: transcutaneous electrical vagal neurostimulation
Twelve weeks home therapy with transcutaneous electrical neurostimulation (TENSeco®, CE197, Schwa-Medico Gmbh), transcutaneous 2-channel nerve stimulator. Matching ear electrode 3 DTS. * Stimulation frequency: 25 Hertz * Intensity: sensitive threshold; clearly perceptible, but pleasant * Form of stimulation: biphasic * Duration: 30 min * Position: left ear * Frequency: daily, in the evening, when all daily activities are done
Device: transcutaneous electrical vagal neurostimulation
Twelve weeks home therapy with transcutaneous electrical neurostimulation (TENSeco®, CE197, Schwa-Medico Gmbh), transcutaneous 2-channel nerve stimulator. Matching ear electrode 3 DTS. * Stimulation frequency: 2 Hertz * Intensity: sensitive threshold; clearly perceptible, but pleasant * Form of stimulation: biphasic * Duration: 30 min * Position: left ear * Frequency: daily, in the evening, when all daily activities are done
Device: transcutaneous electrical vagal neurostimulation
daily for 12 weeks
Heart rate variability
20-minute documentation of the heart rate variability with a 24-hour-elektrocardiography
Time frame: 3 times for 12 weeks
blood pressure and pulse
via Boso Medicus plus their mutiplication for the rate-pressure-product
Time frame: 3 times for 12 weeks
Saliva cortisol
in the morning until the latest 10am
Time frame: 3 times for 12 weeks
Questionnaire Brief Fatigue Inventory (BFI)
Fatigue evaluation
Time frame: 3 times for 12 weeks
Questionnaire Short form (SF)-36
Health related quality of life evaluation
Time frame: 3 times for 12 weeks
Questionnaire Borg-Scale
Dyspnea evaluation
Time frame: 3 times for 12 weeks
Questionnaire Insomnia Severity Index (ISI)
Sleep evaluation
Time frame: 3 times for 12 weeks
Post-COVID-19 Functional Status scale (PCFS)
Grade 0-4
Time frame: 3 times for 12 weeks
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of Vienna