Vagus Nerve StimulationVnstar-IIaNCT06421090
Transauricular Vagal Nerve Stimulation Improves Postoperative Delirium in Elderly Patients
A study testing Transauricular Vagal Nerve Stimulation in people with Vagus Nerve Stimulation, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To investigate the efficacy and safety of perioperative Transauricular vagal nerve stimulation in improving Postoperative Delirium in elderly patients undergoing elective surgery Lay the groundwork for a Phase III study. 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 Vagal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
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: Safety and Feasibility of Transauricular Vagus Nerve Stimulation in Improving Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
To investigate the efficacy and safety of perioperative Transauricular vagal nerve stimulation in improving Postoperative Delirium in elderly patients undergoing elective surgery Lay the groundwork for a Phase III study.
Read the detailed description
This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of Transauricular vagal nerve stimulation(taVNS) to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive taVNS, while the control group will only wear a taVNS stimulator without current stimulation.
- Conditions
- Vagus Nerve Stimulation
- Being tested
- Transauricular Vagal Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transauricular Vagal Nerve StimulationDevice
Transauricular vagal nerve stimulation，Intervention group25Hz，Control group1Hz
| Study group | Role | What they receive |
|---|---|---|
| Transauricular Vagal Nerve Stimulation | Active comparator | Not described Receives: Device: Transauricular Vagal Nerve Stimulation |
| Transauricular Vagal Nerve sham Stimulation | Sham comparator | Not described Receives: Device: Transauricular Vagal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
TaVNS tolerance
The proportion of subjects who completed all the expected interventions
Measured: 1-5 days after surgery
Incidence of adverse events
Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc
Measured: At discharge，an average of 2 weeks
Secondary outcomes (5)
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
Incidence of cognitive decline
The MMSE scale and MoCA scale was used for evaluation
Measured: Day 1 before surgery, day 5 after surgery, day 90 after surgery
All-cause mortality
Measured: on the 90 days
Postoperative pain
VAS score
Measured: 1-5 days after surgery
Time of anesthesia recovery
Measured: Within 2 hours after the end of the surgery
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 start21 May 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 150 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
- NCT06421090
- Sponsor's protocol ID
- VNS20240510IIa
- Acronym
- Vnstar-IIa
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Transauricular Vagus Nerve Stimulation in Improving Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06421090
- Acronym / sponsor ID
- Vnstar-IIa / VNS20240510IIa
- Conditions
- Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (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.
To investigate the efficacy and safety of perioperative Transauricular vagal nerve stimulation in improving Postoperative Delirium in elderly patients undergoing elective surgery Lay the groundwork for a Phase III study.
Detailed description
This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of Transauricular vagal nerve stimulation(taVNS) to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive taVNS, while the control group will only wear a taVNS stimulator without current stimulation.
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 |
|---|---|---|
| Transauricular Vagal Nerve Stimulation | Active comparator | Device: Transauricular Vagal Nerve Stimulation |
| Transauricular Vagal Nerve sham Stimulation | Sham comparator | Device: Transauricular Vagal Nerve Stimulation |
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 Vagal Nerve StimulationTransauricular vagal nerve stimulation，Intervention group25Hz，Control group1Hz | Device | Transauricular Vagal Nerve Stimulation, Transauricular Vagal Nerve sham Stimulation |
Primary outcome
TaVNS tolerance
Time frame: 1-5 days after surgery
The proportion of subjects who completed all the expected interventions
Incidence of adverse events
Time frame: At discharge，an average of 2 weeks
Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc
5 secondary outcomes
Incidence of POD at discharge or within 5 days postoperatively
Time frame: At discharge or within 5 days postoperatively
Incidence of cognitive decline
Time frame: Day 1 before surgery, day 5 after surgery, day 90 after surgery
All-cause mortality
Time frame: on the 90 days
Postoperative pain
Time frame: 1-5 days after surgery
Time of anesthesia recovery
Time frame: Within 2 hours after the end of the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- 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. This study is not recruiting at the moment.
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 Vagal 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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?
Results are not available in the source record.
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?
TaVNS tolerance (time frame: 1-5 days after surgery). The study lists 2 primary outcomes in all. 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 3 Jul 2024.