Vagus Nerve StimulationVnstarNCT06421077
Transcutaneous Auricular Vagus Nerve Stimulation Prevents Postoperative Delirium in Elderly Patients
A study testing transauricular auricular vagus nerve stimulation in people with Vagus Nerve Stimulation, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
According to the 3D-CAM scale, evaluate the incidence of Postoperative Delirium within 5 days after surgery in elderly patients receiving taVNS.The results are expected to provide evidence of the safety and efficacy of perioperative prophylactic use of taVNS in the clinical application of improving postoperative brain… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Vagus Nerve Stimulation
- What is being tested?
- transauricular auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,776 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 31 Dec 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age≥65 years
- Expected operation time≥ 2 hours
- Postoperative hospital stay≥ 4 days
- Sign the informed consent form
Who cannot join
- Neurosurgery or cardiac surgery
- Emergency surgery within 6 hours of admission
- End-stage disease with an expected survival of < 3 months
- Preoperative severe cognitive dysfunction affected perioperative cognitive function assessment
- Severe sinus bradycardia, AVB of degree II and above, pacemaker placement
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
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
Ruquan Han, M.D., Ph.D, 8610-59976660, ruquan.han@gmail.com
Ruquan Han, M.D., Ph.D
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation （taVNS）Prevents Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
According to the 3D-CAM scale, evaluate the incidence of Postoperative Delirium within 5 days after surgery in elderly patients receiving taVNS.The results are expected to provide evidence of the safety and efficacy of perioperative prophylactic use of taVNS in the clinical application of improving postoperative brain health in elderly patients, as well as theoretical and practical basis for subsequent studies or clinical applications.
Read the detailed description
This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of taVNS to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive "standard-stimulation parameters" of taVNS（25HZ，250μs）, while the control group will receive "low-stimulation parameters" of taVNS(1HZ,250μs). The main outcome measure of the study was the incidence of POD within 5 days after surgery. Secondary outcome measures include incidence of new mild and severe postoperative neurocognitive impairment during hospitalization and 90 days, all-cause mortality rate at 90 days, incidence of related adverse events, and length of stay.
- Conditions
- Vagus Nerve Stimulation
- Being tested
- transauricular auricular vagus nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transauricular auricular vagus nerve stimulationDevice
transauricular auricular vagus nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| taVNS with "standard-stimulation parameters" | Active comparator | with a current stimulation frequency of 25 Hz and a pulse width of 250 μs Receives: Device: transauricular auricular vagus nerve stimulation |
| taVNS with "low-stimulation parameters" | Sham comparator | with a current stimulation frequency of 1 Hz and a pulse width of 250 μs. Receives: Device: transauricular auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POD at discharge or within 5 days postoperatively
POD assessment was performed using the 3D-CAM scale estimate. Assessed 2 times daily until postoperative day 5 or hospital discharge
Measured: At discharge or within 5 days postoperatively
Secondary outcomes (8)
Incidence of delayed cognitive recovery during hospitalization
The MMSE/MoCA scale were used for evaluation
Measured: Day 1 before surgery, day 5 after surgery, day 90 after surgery
Incidence of neurocognitive dysfunction at 90 days postoperatively
assessed by AMTS scale
Measured: on the 90 days
Degree of decline in activities of daily living at 90 days postoperatively
use the IADL score
Measured: on the 90 days
All-cause mortality
Measured: on the 90 days
Incidence of unplanned ICU or HDU admissions
Measured: on the 90 days
Proportion of patients requiring higher levels of care postdischarge, specifically long-term care.
Measured: on the 90 days
Length of hospital stay
Measured: on the 90 days
Delirium severity
Delirium severity was assessed via the 3D-CAM-S scale. 3D-CAM-S scale: The total score is 7, with 0 being normal, 1 being mild delirium, 2 being moderate delirium, and 3-7 being severe delirium
Measured: At discharge or within 5 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start20 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vagus Nerve StimulationStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,776 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421077
- Sponsor's protocol ID
- VNS20240510
- Acronym
- Vnstar
- Status last verified
- Jan 2025
- First submitted
- 10 May 2024
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu Y, Hou X, Wang T, Wang X, Zhang K, Liang F, Jian M, Wang B, Liu H, Wang A, Han R. Transcutaneous auricular vagus nerve stimulation prevents postoperative delirium in elderly patients (VNSTAR): protocol for a multicentre, randomised controlled trial. BMJ Open. 2025 May 30;15(5):e099736. doi: 10.1136/bmjopen-2025-099736.
PubMed 40447430
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation （taVNS）Prevents Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06421077
- Acronym / sponsor ID
- Vnstar / VNS20240510
- Conditions
- Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,776 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 May 2024 (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.
According to the 3D-CAM scale, evaluate the incidence of Postoperative Delirium within 5 days after surgery in elderly patients receiving taVNS.The results are expected to provide evidence of the safety and efficacy of perioperative prophylactic use of taVNS in the clinical application of improving postoperative brain health in elderly patients, as well as theoretical and practical basis for subsequent studies or clinical applications.
Detailed description
This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of taVNS to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive "standard-stimulation parameters" of taVNS（25HZ，250μs）, while the control group will receive "low-stimulation parameters" of taVNS(1HZ,250μs). The main outcome measure of the study was the incidence of POD within 5 days after surgery. Secondary outcome measures include incidence of new mild and severe postoperative neurocognitive impairment during hospitalization and 90 days, all-cause mortality rate at 90 days, incidence of related adverse events, and length of stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS with "standard-stimulation parameters" | Active comparator | Device: transauricular auricular vagus nerve stimulationwith a current stimulation frequency of 25 Hz and a pulse width of 250 μs |
| taVNS with "low-stimulation parameters" | Sham comparator | Device: transauricular auricular vagus nerve stimulationwith a current stimulation frequency of 1 Hz and a pulse width of 250 μs. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age≥65 years
- Expected operation time≥ 2 hours
- Postoperative hospital stay≥ 4 days
- Sign the informed consent form
Key exclusion criteria (5 listed)
- Neurosurgery or cardiac surgery
- Emergency surgery within 6 hours of admission
- End-stage disease with an expected survival of < 3 months
- Preoperative severe cognitive dysfunction affected perioperative cognitive function assessment
- Severe sinus bradycardia, AVB of degree II and above, pacemaker placement
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 |
|---|---|---|
| transauricular auricular vagus nerve stimulationtransauricular auricular vagus nerve stimulation | Device | taVNS with "low-stimulation parameters", taVNS with "standard-stimulation parameters" |
Primary outcome
Incidence of POD at discharge or within 5 days postoperatively
Time frame: At discharge or within 5 days postoperatively
POD assessment was performed using the 3D-CAM scale estimate. Assessed 2 times daily until postoperative day 5 or hospital discharge
8 secondary outcomes
Incidence of delayed cognitive recovery during hospitalization
Time frame: Day 1 before surgery, day 5 after surgery, day 90 after surgery
Incidence of neurocognitive dysfunction at 90 days postoperatively
Time frame: on the 90 days
Degree of decline in activities of daily living at 90 days postoperatively
Time frame: on the 90 days
All-cause mortality
Time frame: on the 90 days
Incidence of unplanned ICU or HDU admissions
Time frame: on the 90 days
Proportion of patients requiring higher levels of care postdischarge, specifically long-term care.
Time frame: on the 90 days
Length of hospital stay
Time frame: on the 90 days
Delirium severity
Time frame: At discharge or within 5 days postoperatively
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 25 Apr 2025.
- Derived from this study: PubMed 40447430Wu Y, Hou X, Wang T, Wang X, Zhang K, Liang F, Jian M, Wang B, Liu H, Wang A, Han R. Transcutaneous auricular vagus nerve stimulation prevents postoperative delirium in elderly patients (VNSTAR): protocol for a multicentre, randomised controlled trial. BMJ Open. 2025 May 30;15(5):e099736. doi: 10.1136/bmjopen-2025-099736.
- Individual participant dataSharing planned: No
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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 transauricular auricular vagus nerve stimulation in people with Vagus Nerve Stimulation, run by Beijing Tiantan Hospital 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 5 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 25 Apr 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 Ruquan Han, MD (8610-59976660, ruquan.han@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of POD at discharge or within 5 days postoperatively (time frame: At discharge or within 5 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06421077, which also lists 1 linked publication.
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 25 Apr 2025.