Non-invasive Nervus Vagus Stimulation in Patients With COVID-19 and ARDS

Noninvasive Vagal Nerve Stimulation in Patients With COVID-19 and ARDS for the Reduction of Respiratory, Hemodynamic and Neuropsychiatric Complications

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05058742

Enrollment

Registered

2021-09-28

Start date

2021-07-15

Completion date

2022-11-30

Last updated

2022-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, COVID-19, Cytokine Storm

Keywords

Nervus vagus stimulation, COVID-19, ARDS, hyperinflammation, cytokine storm

Brief 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. 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.

Interventions

DEVICEAuriStim

Auricular vagal nerve Stimulator, which Targets the auricular branches of the vagal nerve

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* positive SARS-CoV-2 RT-PCR * Acute respiratory failure requiring non-invasive respiratory support (NIV or high flow Oxygen) * PaO2/FiO2 \<200

Exclusion criteria

* 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 * Heart rate \<60/min * Known vagal hypersensitivity * History of hemophilia

Design outcomes

Primary

Measure	Time frame	Description
Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality)	3 months after admission to ICU	retrospective analysis after discharge or death or participant

Countries

Austria

Contacts

Primary ContactReinhard Kitzberger, MD

reinhard.kitzberger@gesundheitsverbund.at+431601910

Backup ContactTamara Seitz, MD

tamara.seitz@gesundheitsverbund.at+4316019172412

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026