NCT07051694 Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients
| NCT ID | NCT07051694 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Third Military Medical University |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-27 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-02-27 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07051694 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07051694 currently recruiting?
Yes, NCT07051694 is actively recruiting participants. Contact the research team at YHeasun@163.com for enrollment information.
Where is the NCT07051694 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT07051694 clinical trial?
NCT07051694 is sponsored by Third Military Medical University. The trial plans to enroll 60 participants.