Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2023-03-22
2025-03-01
Brief Summary
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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.
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Detailed Description
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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°):
* Documentation of blood pressure and pulse rate: by means of Boso Medicus (Bosch + Sohn GmbH u. Co. KG, Jungingen, Germany), calculation of the so-called "rate pressure-product" (syst. blood pressure x heart rate)
* Heart rate variability
* Salivary cortisol
* Fatigue: Brief Fatigue Inventory (BFI)
* Health-related quality of life (HRQOL): SF-36 (short form) questionnaire instrument
* Dyspnea: Modified Borg Scale
* Sleep: Insomnia Severity Index (ISI)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Vagus Nerve Stimulation with 10 Hertz
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
transcutaneous electrical vagal neurostimulation
daily for 12 weeks
Vagus Nerve Stimulation with 25 Hertz
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
transcutaneous electrical vagal neurostimulation
daily for 12 weeks
Vagus Nerve Stimulation with 2 Hertz
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
transcutaneous electrical vagal neurostimulation
daily for 12 weeks
Interventions
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transcutaneous electrical vagal neurostimulation
daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* age 18-70 years
* signed informed consent
Exclusion Criteria
* surgical transection of the vagus nerve
* Malignancies
* autoimmune diseases
* orthopedic diseases
* rheumatological diseases
* neurological diseases
* postoperative, fresh injuries to the ear
* febrile diseases
* inflammations
* psychiatric diseases
* pacemakers
* implanted cardioverter and defibrillators (ICDs)
* seizure disorders
* Meniere's disease
* negative experience with electrotherapy
* insufficient knowledge of the German language
18 Years
70 Years
FEMALE
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Richard Crevenna
Head of Physical Medicine, Rehabilitation and Occupational Medicine
Principal Investigators
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Richard Crevenna, M.D.
Role: PRINCIPAL_INVESTIGATOR
PMR&O
Locations
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Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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1779/2022
Identifier Type: -
Identifier Source: org_study_id
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