SepsisTaVNS-SepsisNCT07051694
Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients
A study testing taVNS in people with Sepsis, run by Third Military Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis
- What is being tested?
- taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Army Medical University
Chongqing
Ethics Committee, 023-68754035, xnyyec@sina.com
About this study
Official title: Exploratory Study on Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients
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
- Sepsis
- Being tested
- taVNS, sham-taVNS
- Keywords
- sepsis, transcutaneous auricular vagus nerve stimulation
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
Transcutaneous Auricular Vagus Nerve Stimulation
sham-taVNSDevice
sham transcutaneous auricular vagus nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| taVNS group | Experimental | transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days. Receives: Device: taVNS |
| sham-taVNS group | Sham comparator | sham transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days. Receives: Device: sham-taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA socre
The total SOFA score is obtained by adding the scores of the six systems: respiratory, coagulation, liver, cardiovascular, central nervous, and renal. The SOFA score ranges from 0 to 24, with a higher score indicating more severe organ dysfunction.
Measured: Baseline and Day 8
Secondary outcomes (6)
blood
Routine complete blood count
Measured: Baseline and Day 8
Glasgow coma scale
pecific scoring criteria were established for eye opening, verbal response, and motor response, with maximum scores of 4, 5, and 6 points respectively. A higher score indicating better condition.
Measured: Baseline and Day 8
tidal volume
tested by mechanical ventilation
Measured: Baseline and Day 8
vasoactive-intropic score
VIS can intuitively reflect the degree of dependence of sepsis patients on vasoactive drugs, providing a quantitative indicator for clinicians. It helps to more accurately assess the condition of sepsis, evaluate the therapeutic effect and predict the prognosis. The larger the value, the more severe the condition.
Measured: Baseline and Day 8
Arterial blood gas (ABG) analysis
Arterial blood gas (ABG) analysis
Measured: Baseline and Day 8
fraction of inspiration O2
tested by mechanical ventilation
Measured: Baseline and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start27 Feb 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Liang, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051694
- Sponsor's protocol ID
- AIIT2024050
- Acronym
- TaVNS-Sepsis
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: ResMan, http://www.medresman.org.cn/login.aspx
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients
- ClinicalTrials.gov ID
- NCT07051694
- Acronym / sponsor ID
- TaVNS-Sepsis / AIIT2024050
- Conditions
- Sepsis
- Keywords
- sepsis, transcutaneous auricular vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS group | Experimental | Device: taVNStranscutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days. |
| sham-taVNS group | Sham comparator | Device: sham-taVNSsham transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taVNSTranscutaneous Auricular Vagus Nerve Stimulation | Device | taVNS group |
| sham-taVNSsham transcutaneous auricular vagus nerve stimulation | Device | sham-taVNS group |
Primary outcome
SOFA socre
Time frame: Baseline and Day 8
The total SOFA score is obtained by adding the scores of the six systems: respiratory, coagulation, liver, cardiovascular, central nervous, and renal. The SOFA score ranges from 0 to 24, with a higher score indicating more severe organ dysfunction.
6 secondary outcomes
blood
Time frame: Baseline and Day 8
Glasgow coma scale
Time frame: Baseline and Day 8
tidal volume
Time frame: Baseline and Day 8
vasoactive-intropic score
Time frame: Baseline and Day 8
Arterial blood gas (ABG) analysis
Time frame: Baseline and Day 8
fraction of inspiration O2
Time frame: Baseline and Day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Yes. ResMan, http://www.medresman.org.cn/login.aspx
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS in people with Sepsis, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Yang, PhD (+8618580262250, YHeasun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOFA socre (time frame: Baseline and Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.