Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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°): - 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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05918965
Study type Interventional
Source Medical University of Vienna
Contact Veronika Helbich-Poschacher, M.D.
Phone +4314040043300
Email veronika.helbich-poschacher@meduniwien.ac.at
Status Recruiting
Phase N/A
Start date March 22, 2023
Completion date March 1, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05926505 - Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome Phase 2/Phase 3
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Completed NCT05552612 - Health-related Quality of Life and Long COVID
Completed NCT05531019 - COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea Urchin Eggs With Echinochroma A N/A
Not yet recruiting NCT04949386 - Safety, Tolerability and Efficacy of S-1226 in Post-COVID-19 Subjects With Persistent Respiratory Symptoms. Phase 2
Recruiting NCT06118112 - Living With Long COVID: LONGCOVID-EXPERIENCE
Completed NCT05185674 - Sociodemographic, Clinical, Quality of Life and Health Care Conditions in COVID-19 Survivors.
Active, not recruiting NCT05965752 - RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long COVID Symptoms N/A
Active, not recruiting NCT05965739 - RECOVER-NEURO: Platform Protocol, Appendix_A to Measure the Effects of BrainHQ, PASC CoRE and tDCS Interventions on Long COVID Symptoms N/A
Completed NCT05812209 - Stellate Ganglion Block to Treat Long COVID 19 Case Series
Recruiting NCT05606211 - Pain in Long COVID-19: The Role of Sleep
Active, not recruiting NCT05713266 - Using Data From a Multisensor Rapid Health Assessment Device to Predict Decompensation in Long COVID (AIDI)
Completed NCT05601180 - Evaluation of the Efficacy of Respicure® (Resveratrol / Quercetin) in the Management of Respiratory Conditions Including Asthma,COPD and Long COVID. N/A
Completed NCT05679505 - Vagus Nerve Stimulation for Post-COVID Syndrome N/A
Not yet recruiting NCT06045338 - Mind Body Intervention for Long COVID N/A
Recruiting NCT06091358 - Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation. N/A
Recruiting NCT05566392 - Longterm Influence of Pediatric Long COVID Syndrome
Recruiting NCT05855369 - Smell Training and Trigeminal Nerve Stimulation for COVID-related Smell Loss Phase 2/Phase 3
Recruiting NCT05572346 - Digital App for Telerehabilitation in Respiratory Diseases
Recruiting NCT06316843 - Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2 Phase 2