Ear (auricular) vagus nerve stimulation added to ICU care for sepsis
Official title: Exploratory Study on Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients
Run by Third Military Medical University · NCT07051694 · Data updated 2026-11-12
This trial will test whether gentle electrical stimulation of the ear (taVNS), given twice daily along with standard intensive care, can reduce inflammation and organ dysfunction in adults with sepsis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Third Military Medical University Academic / other |
| Locations | 1 site (Chongqing) |
| Status | Recruiting |
| Started | February 27, 2025 |
| Main results expected | October 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 4, 2025 |
| Trial ID | NCT07051694 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 diagnosed with sepsis by Sepsis-3 criteria, admitted to the ICU within seven days of sepsis onset, and able to give informed consent (or with a consenting guardian) are ideal candidates.
✕Probably not a fit
Patients with severe ARDS, very high heart rates or vasopressor requirements, active implantable electronic devices (like pacemakers), significant ear skin disease, pregnancy, or inability to remain still are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, sham-controlled study in which adults with sepsis receiving ICU care will get either active transcutaneous auricular vagus nerve stimulation (taVNS) or a sham procedure twice a day for seven days in addition to standard care. Patients will be enrolled within seven days of sepsis onset and evaluated with clinical and laboratory measures before and after the intervention. The trial will measure systemic inflammation markers and organ function to see if taVNS lowers sepsis severity and to explore possible mechanisms of benefit. Safety and feasibility in the ICU setting will also be monitored throughout the treatment period.
Why it matters
Potential benefit: If successful, taVNS could reduce systemic inflammation and improve organ function, potentially lowering complications and improving recovery in sepsis patients.
How similar studies have gone: Vagus nerve stimulation approaches have shown anti-inflammatory effects in preclinical and small human studies, but taVNS specifically for sepsis remains largely novel and unproven in large clinical trials.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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The First Affiliated Hospital of Army Medical University
Chongqing, China Recruiting
Study contacts
- Study coordinator: Hong Yang, PhD
- Email: YHeasun@163.com
- Phone: +8618580262250
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.