Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients

NCT ID: NCT07051694

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-27

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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taVNS group

transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days.

Group Type EXPERIMENTAL

taVNS

Intervention Type DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

sham-taVNS group

sham transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days.

Group Type SHAM_COMPARATOR

sham-taVNS

Intervention Type DEVICE

sham transcutaneous auricular vagus nerve stimulation

Interventions

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taVNS

Transcutaneous Auricular Vagus Nerve Stimulation

Intervention Type DEVICE

sham-taVNS

sham transcutaneous auricular vagus nerve stimulation

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Tan Liang

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Army Medical University

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Yang, PhD

Role: CONTACT

+8618580262250

Facility Contacts

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Ethics Committee

Role: primary

023-68754035

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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AIIT2024050

Identifier Type: -

Identifier Source: org_study_id

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