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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°):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vagus Nerve Stimulation with 10 Hertz | Active Comparator | Twelve weeks home therapy with transcutaneous electrical neurostimulation (TENSeco®, CE197, Schwa-Medico Gmbh), transcutaneous 2-channel nerve stimulator. Matching ear electrode 3 DTS.
|
|
| Vagus Nerve Stimulation with 25 Hertz | Active Comparator | Twelve weeks home therapy with transcutaneous electrical neurostimulation (TENSeco®, CE197, Schwa-Medico Gmbh), transcutaneous 2-channel nerve stimulator. Matching ear electrode 3 DTS.
|
|
| Vagus Nerve Stimulation with 2 Hertz | Experimental | Twelve weeks home therapy with transcutaneous electrical neurostimulation (TENSeco®, CE197, Schwa-Medico Gmbh), transcutaneous 2-channel nerve stimulator. Matching ear electrode 3 DTS.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous electrical vagal neurostimulation | Device | daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | 20-minute documentation of the heart rate variability with a 24-hour-elektrocardiography | 3 times for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure and pulse | via Boso Medicus plus their mutiplication for the rate-pressure-product | 3 times for 12 weeks |
| Saliva cortisol | in the morning until the latest 10am |
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Inclusion Criteria:
Exclusion Criteria:
More women are affected by Long Covid, also the homogeneity is granted in a small study population.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronika Helbich-Poschacher, M.D. | Contact | +4314040043300 | veronika.helbich-poschacher@meduniwien.ac.at | |
| Mohammad Keilani, M.D. | Contact | +4314040043300 | mohammad.keilani@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Richard Crevenna, M.D. | PMR&O | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33892403 | Background | Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: An overview. Diabetes Metab Syndr. 2021 May-Jun;15(3):869-875. doi: 10.1016/j.dsx.2021.04.007. Epub 2021 Apr 20. | |
| 33483331 | Background | Shah W, Hillman T, Playford ED, Hishmeh L. Managing the long term effects of covid-19: summary of NICE, SIGN, and RCGP rapid guideline. BMJ. 2021 Jan 22;372:n136. doi: 10.1136/bmj.n136. No abstract available. |
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| ID | Term |
|---|---|
| D020421 | Vagus Nerve Diseases |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
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| 3 times for 12 weeks |
| Questionnaire Brief Fatigue Inventory (BFI) | Fatigue evaluation | 3 times for 12 weeks |
| Questionnaire Short form (SF)-36 | Health related quality of life evaluation | 3 times for 12 weeks |
| Questionnaire Borg-Scale | Dyspnea evaluation | 3 times for 12 weeks |
| Questionnaire Insomnia Severity Index (ISI) | Sleep evaluation | 3 times for 12 weeks |
| Post-COVID-19 Functional Status scale (PCFS) | Grade 0-4 | 3 times for 12 weeks |
| 35726132 | Background | Sylvester SV, Rusu R, Chan B, Bellows M, O'Keefe C, Nicholson S. Sex differences in sequelae from COVID-19 infection and in long COVID syndrome: a review. Curr Med Res Opin. 2022 Aug;38(8):1391-1399. doi: 10.1080/03007995.2022.2081454. Epub 2022 Jun 20. |
| 33243837 | Background | Dani M, Dirksen A, Taraborrelli P, Torocastro M, Panagopoulos D, Sutton R, Lim PB. Autonomic dysfunction in 'long COVID': rationale, physiology and management strategies. Clin Med (Lond). 2021 Jan;21(1):e63-e67. doi: 10.7861/clinmed.2020-0896. Epub 2020 Nov 26. |
| 32458400 | Background | Fudim M, Qadri YJ, Ghadimi K, MacLeod DB, Molinger J, Piccini JP, Whittle J, Wischmeyer PE, Patel MR, Ulloa L. Implications for Neuromodulation Therapy to Control Inflammation and Related Organ Dysfunction in COVID-19. J Cardiovasc Transl Res. 2020 Dec;13(6):894-899. doi: 10.1007/s12265-020-10031-6. Epub 2020 May 26. |
| D011014 |
| Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |