COVID-19NCT05058742
Non-invasive Nervus Vagus Stimulation in Patients With COVID-19 and ARDS
A study testing AuriStim in people with COVID-19 and ARDS, run by Vienna Hospital Association at 1 site in Austria.
Trial summary
Critical ill COVID-19 patients often develop respiratory, hemodynamic and neuropsychiatric complications. An imbalance of sympatho-parasympathetic nervous system is discussed as one of the reasons. The nervus vagus is essential for controlling the sympatho-parasympathetic nervous system and the inflammatory processes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, ARDS, Cytokine Storm
- What is being tested?
- AuriStim
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 15 Jul 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- positive SARS-CoV-2 RT-PCR
- Acute respiratory failure requiring non-invasive respiratory support (NIV or high flow Oxygen)
- PaO2/FiO2 <200
Who cannot join
- Age <18 years
- Pregnancy (to be excluded using Serum betaHCG in women of childbearing age)
- Signs of infection, eczema or Psoriasis at the application site
- Active malignancy
- Implanted cardiac Pacemaker, deficrillator or other active implanted electrical devices
- Patient unable to consent
Show all 9Show fewer
- Heart rate <60/min
- Known vagal hypersensitivity
- History of hemophilia
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Klinik Favoriten
Vienna, 1100
Reinhard Kitzberger, MD, +4301601910, reinhard.kitzberger@gesundheitsverbund.at
Tamara Seitz, MD, +43016019172412, tamara.seitz@gesundheitsverbund.at
About this study
Official title: Noninvasive Vagal Nerve Stimulation in Patients With COVID-19 and ARDS for the Reduction of Respiratory, Hemodynamic and Neuropsychiatric Complications
Critical ill COVID-19 patients often develop respiratory, hemodynamic and neuropsychiatric complications. An imbalance of sympatho-parasympathetic nervous system is discussed as one of the reasons. The nervus vagus is essential for controlling the sympatho-parasympathetic nervous system and the inflammatory processes.
Aim of this study is to evaluate whether Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality) in critical ill patients.
Read the detailed description
Introduction:
Critical ill COVID-19 patients often develop respiratory, hemodynamic and neuropsychiatric complications. An imbalance of sympatho-parasympathetic nervous system is discussed as one of the reasons. The nervus vagus is essential for controlling the sympatho-parasympathetic nervous system and the inflammatory processes. A method to stimulate the nervus vagus, is the non-invasive Nervus Vagus Stimulation with AuriStim.
Aims:
Aim of this study is to evaluate whether Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality) in critical ill patients.
Methods:
All patients admitted to ICU at Klinik Favoriten with COVID-19 and moderate to severe ARDS are asked to partcipate. After written consent, a randomisation in Treatment-group (Vagal Nervus Stimulation 4 times a day for each 3 hours until transfer to nomal ward or death) or Non-Treatment-Group is done. In case of stimulation, side effects or intolerance are documented. After discharge or death of the patient, outcomeparameters are evaluated (need of mechanical ventilation, hospital stay, mortality, etc.) and compared between patients of Treatment-Group and Non-Treatment-Group.
- Conditions
- COVID-19, ARDS, Cytokine Storm
- Being tested
- AuriStim
- Keywords
- Nervus vagus stimulation, COVID-19, ARDS, hyperinflammation, cytokine storm
- Medical subject headings
- COVID-19, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuriStimDevice
Auricular vagal nerve Stimulator, which Targets the auricular branches of the vagal nerve
| Study group | Role | What they receive |
|---|---|---|
| Nervus vagus stimulation | Experimental | Non-invasive Nervus vagus stimulation called AuriStim Intermittent stimluation cycle of three hours of activity and three hours of rest, equating to four cycles of three hours of Stimulation in 24 hours) is performed. The stimulation is performed until the patient's condition is better and he or she isdischarged from OCU or transferred to normal ward or dies. Receives: Device: AuriStim |
| Control | No intervention | There is no Nervus vagus stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality)
retrospective analysis after discharge or death or participant
Measured: 3 months after admission to ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start15 Jul 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Hospital Association
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alexander Zoufaly, MD, Principal investigator, Klinik FavoritenEugenijus Kaniusas, Prof. Dr., Study chair, Vienna University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058742
- Sponsor's protocol ID
- VNS
- Status last verified
- Oct 2022
- First submitted
- 25 Sep 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Vagal Nerve Stimulation in Patients With COVID-19 and ARDS for the Reduction of Respiratory, Hemodynamic and Neuropsychiatric Complications
- ClinicalTrials.gov ID
- NCT05058742
- Acronym / sponsor ID
- VNS
- Conditions
- COVID-19, ARDS, Cytokine Storm
- Keywords
- Nervus vagus stimulation, COVID-19, ARDS, hyperinflammation, cytokine storm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vienna Hospital AssociationOther government
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Critical ill COVID-19 patients often develop respiratory, hemodynamic and neuropsychiatric complications. An imbalance of sympatho-parasympathetic nervous system is discussed as one of the reasons. The nervus vagus is essential for controlling the sympatho-parasympathetic nervous system and the inflammatory processes.
Aim of this study is to evaluate whether Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality) in critical ill patients.
Detailed description
Introduction:
Critical ill COVID-19 patients often develop respiratory, hemodynamic and neuropsychiatric complications. An imbalance of sympatho-parasympathetic nervous system is discussed as one of the reasons. The nervus vagus is essential for controlling the sympatho-parasympathetic nervous system and the inflammatory processes. A method to stimulate the nervus vagus, is the non-invasive Nervus Vagus Stimulation with AuriStim.
Aims:
Aim of this study is to evaluate whether Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality) in critical ill patients.
Methods:
All patients admitted to ICU at Klinik Favoriten with COVID-19 and moderate to severe ARDS are asked to partcipate. After written consent, a randomisation in Treatment-group (Vagal Nervus Stimulation 4 times a day for each 3 hours until transfer to nomal ward or death) or Non-Treatment-Group is done. In case of stimulation, side effects or intolerance are documented. After discharge or death of the patient, outcomeparameters are evaluated (need of mechanical ventilation, hospital stay, mortality, etc.) and compared between patients of Treatment-Group and Non-Treatment-Group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nervus vagus stimulation | Experimental | Device: AuriStimNon-invasive Nervus vagus stimulation called AuriStim Intermittent stimluation cycle of three hours of activity and three hours of rest, equating to four cycles of three hours of Stimulation in 24 hours) is performed. The stimulation is performed until the patient's condition is better and he or she isdischarged from OCU or transferred to normal ward or dies. |
| Control | No intervention | –There is no Nervus vagus stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- positive SARS-CoV-2 RT-PCR
- Acute respiratory failure requiring non-invasive respiratory support (NIV or high flow Oxygen)
- PaO2/FiO2 <200
Key exclusion criteria (9 listed)
- Age <18 years
- Pregnancy (to be excluded using Serum betaHCG in women of childbearing age)
- Signs of infection, eczema or Psoriasis at the application site
- Active malignancy
- Implanted cardiac Pacemaker, deficrillator or other active implanted electrical devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AuriStimAuricular vagal nerve Stimulator, which Targets the auricular branches of the vagal nerve | Device | Nervus vagus stimulation |
Primary outcome
Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality)
Time frame: 3 months after admission to ICU
retrospective analysis after discharge or death or participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Zoufaly, MD principal investigator
Klinik Favoriten
Eugenijus Kaniusas, Prof. Dr. study chair
Vienna University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AuriStim in people with COVID-19 and ARDS, run by Vienna Hospital Association at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reinhard Kitzberger, MD (+431601910, reinhard.kitzberger@gesundheitsverbund.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality) (time frame: 3 months after admission to ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.