Actively Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients
Led by Third Military Medical University · Updated on 2025-07-04
60
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goals of this randomized clinical trial are to investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) combined with standard intensive care on systemic organ function in septic patients, and exploring its potential mechanisms for improving overall outcomes in sepsis.The main question it aims to answer is whether taVNS can reduce the severity of sepsis patients by ameliorating systemic inflammation.Participants will receive standard intensive care treatment and be randomized to receive the taVNS or sham taVNS as adjuvant treatment twice a day for 7 consecutive days. Several evaluations will be done before and after the intervention.
CONDITIONS
Official Title
Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-80
- Diagnosed with sepsis using Sepsis-3 criteria with SOFA score 63 2
- ICU admission within 7 days after sepsis onset
- Informed consent obtained from patients or guardians
You will not qualify if you...
- Severe ARDS defined by PaO2/FiO2 100 mmHg with PEEP 5 cm H2O
- Heart rate over 120 beats per minute
- Receiving epinephrine or norepinephrine over 1 ug/kg/min
- Severe lung diseases including interstitial lung disease, diffuse alveolar hemorrhage, severe asthma, or lung cancer
- Existing pacemakers, cochlear implants, or other active implantable electronic devices
- Skin or infectious disorders affecting the ear region
- Pregnancy or breastfeeding
- Participation in other clinical trials
- Inability to stay still during treatment due to conditions like epilepsy or Parkinson's disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Army Medical University
Chongqing, China
Actively Recruiting
Research Team
H
Hong Yang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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