Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients

Launched by THIRD MILITARY MEDICAL UNIVERSITY · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a treatment called transcutaneous auricular vagus nerve stimulation (taVNS)—a gentle electrical stimulation applied to the ear—can help improve the health of patients with sepsis, a serious condition caused by the body's response to infection. The study aims to see if adding taVNS to the usual intensive care can reduce inflammation throughout the body and protect organs from damage, potentially helping patients recover better.

Adults aged 18 to 80 who have been diagnosed with sepsis and admitted to the intensive care unit within a week of their diagnosis may be eligible to join. Participants will continue to receive standard care and will be randomly assigned to get either the real taVNS treatment or a sham (placebo) version twice daily for a week. The procedure is non-invasive and done while the patient is resting. The study will closely monitor patients before and after treatment to understand its effects. People with certain lung problems, very fast heart rates, implanted electronic devices like pacemakers, or those who cannot stay still during treatment might not be able to participate. This trial is currently recruiting patients and hopes to find new ways to support those fighting sepsis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-80
• • Sepsis was diagnosed per the Sepsis-3 criteria (SCCM/ESICM 2016) as infection with SOFA score ≥ 2
• • ICU admission within 7 days after sepsis onset
• • Informed consent was obtained from patients/guardians
• Exclusion Criteria:
• • severe ARDS defined by PaO₂/FiO₂ ≤100 mmHg with PEEP ≥5 cm H₂O
• • HR\>120 per minute
• • epinephrine or norepinephrine \>1ug/kg/min
• • severe underlying pulmonary diseases including interstitial lung disease, -
• • diffuse alveolar hemorrhage, severe asthma, or lung cancer
• • taVNS contraindications: existing pacemakers, cochlear implants, or other active implantable electronic medical devices
• • dermatologic or infectious disorders affecting the auricular region
• • pregnancy or lactation
• • participation in other clinical trials
• • inability to remain motionless during treatment (e.g., due to epilepsy or Parkinson's disease)