Postoperative Delirium (POD)NCT07476742
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium and Negative Emotions in Patients Undergoing Cardiac Surgery
A study testing Active taVNS in people with Postoperative Delirium (POD) and Postoperative, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
A multicenter, randomized, double-blind, sham-controlled trial to investigate the effects of intraoperative transcutaneous auricular vagus nerve stimulation (taVNS) on the incidence of postoperative delirium and negative emotional states (anxiety, depression) in patients undergoing elective cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Delirium (POD), Postoperative, Anxiety
- What is being tested?
- Active taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 28 Feb 2027
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 85 years. Scheduled for elective cardiac surgery (e.g., CABG, valve replacement/repair). NYHA cardiac function class I-III. Willing and able to provide informed consent. Expected surgery duration ≥ 2 hours.
Who cannot join
- Preoperative MMSE score < 24; severe communication barriers. History of diagnosed delirium, dementia, Parkinson's disease, schizophrenia, bipolar disorder, major depressive disorder, or long-term use of psychotropic drugs.
- Skin lesions, infection, or deformity of bilateral ears; history of ear surgery or nerve injury; allergy to electrode materials.
- Severe arrhythmia; implanted electronic devices (e.g., pacemaker, ICD). Participation in another interventional trial within 3 months. Other conditions deemed unsuitable by investigators.
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
First Medical Center of Chinese PLA General Hospital, Beijing, China.
Beijing
About this study
Official title: Effect of Intraoperative Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium and Negative Emotional States in Patients Undergoing Cardiac Surgery: A Multicenter, Randomized, Double-Blind, Sham-Controlled Trial
A multicenter, randomized, double-blind, sham-controlled trial to investigate the effects of intraoperative transcutaneous auricular vagus nerve stimulation (taVNS) on the incidence of postoperative delirium and negative emotional states (anxiety, depression) in patients undergoing elective cardiac surgery.
Read the detailed description
Cardiac surgery is associated with a high risk of postoperative neurocognitive disorders, including delirium and negative emotional states such as anxiety and depression, which significantly impact patient recovery and long-term outcomes. This study aims to evaluate whether intraoperative taVNS, a non-invasive neuromodulation technique, can reduce the incidence and severity of these complications. Patients will be randomized to receive either active taVNS or sham stimulation during surgery. Outcomes including delirium, anxiety, depression, pain, sleep quality, recovery quality, and relevant biomarkers will be assessed postoperatively.
- Conditions
- Postoperative Delirium (POD), Postoperative, Anxiety, Depression, Cardiac Surgical Procedures
- Being tested
- Active taVNS, Sham taVNS Group
- Keywords
- Transcutaneous Vagus Nerve Stimulation, Cardiac Surgery, Postoperative Delirium, Depression, Anxiety, Randomized Controlled Trial
- Medical subject headings
- Emergence Delirium, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active taVNSDevice
Stimulation parameters: Amplitude 20 (mA), Frequency 20Hz, Pulse width 200μs, asymmetric biphasic square wave. The current is gradually increased from 10mA to a level slightly below the individual's "prickling" sensation threshold (20-60mA). Stimulation is applied to the left auricular concha for 30 minutes after anesthesia induction and for another 30 minutes after cardiopulmonary bypass weaning.
Sham taVNS GroupDevice
The sham device is identical in appearance, weight, indicator lights, and operation sounds to the active device but delivers no effective electrical current. It is applied to the left auricular concha at the same time points as the active group (30 minutes after induction and 30 minutes after CPB weaning).
| Study group | Role | What they receive |
|---|---|---|
| Active taVNS Group | Experimental | Patients receiving active transcutaneous auricular vagus nerve stimulation during surgery. Receives: Device: Active taVNS |
| Sham taVNS Group | Sham comparator | Patients receiving sham (placebo) stimulation with an identical device during surgery. Receives: Device: Sham taVNS Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Delirium
Postoperative delirium will be assessed using the 3-Minute Diagnostic Interview for CAM (3D-CAM) for general ward patients and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for ICU patients, from postoperative day 1 to day 7. Diagnosis requires the presence of acute onset/fluctuating course and inattention, plus either disorganized thinking or altered level of consciousness.
Measured: Within 7 days after surgery
Secondary outcomes (11)
Incidence and Severity of Postoperative Depression
Postoperative Anxiety Incidence and Severity: HADS-D (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score.Higher score indicates greater depression severity. A score ≥ 8 is considered clinically significant for depression (per standard cutoff).
Measured: Preoperative day, Postoperative day 1, 2, 3, 7, and 30
Incidence and Severity of Postoperative Anxiety
Postoperative Anxiety Incidence and Severity: HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score. Higher score indicates greater anxiety severity. A score ≥ 8 is considered clinically significant for anxiety (per standard cutoff).
Measured: Preoperative day, Postoperative day 1, 2, 3, 7, and 30
Incidence and Severity of Postoperative Depression
Assessed using Hamilton Depression Rating Scale (HAMD-17). Scores above standard cut-offs indicate depressive states.
Measured: Preoperative day, Postoperative day 1, 2, 3, 7, and 30
Incidence and Severity of Postoperative Anxiety (HADS-A)
Assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A) at specified time points. Scores above standard cut-offs indicate anxiety states.
Measured: Preoperative day, Postoperative day 1, 2, 3, 7, and 30
Postoperative Agitation Score
Assessed using the Riker Sedation-Agitation Scale (SAS) at the time of extubation.
Measured: At the time of extubation (within 24 hours post-surgery)
Postoperative Nausea and Vomiting (PONV)
Assessed using a Visual Analogue Scale (VAS, 0-10) within 3 days after extubation.
Measured: Within 3 days after extubation
Postoperative Pain Score
Assessed using the Numerical Rating Scale (NRS, 0-10).
Measured: Postoperative day 1, 2, 3, 7, and 30
Postoperative Sleep Quality
Assessed using the Insomnia Severity Index (ISI, score 0-28).
Measured: Postoperative day 1, 2, 3, 7, and 30
Postoperative Recovery Quality
Assessed using the Quality of Recovery-15 or QoR-40 scale.
Measured: Postoperative day 7 and 30
Incidence and Severity of Postoperative Anxiety (GAD-7)
Assessed using the Generalized Anxiety Disorder-7 (GAD-7) at specified time points. Scores above standard cut-offs indicate anxiety states.
Measured: Preoperative day, Postoperative day 1, 2, 3, 7, and 30
Incidence and Severity of Postoperative Anxiety (SAS)
Assessed using the Self-Rating Anxiety Scale (SAS) at specified time points. Scores above standard cut-offs indicate anxiety states.
Measured: Preoperative day, Postoperative day 1, 2, 3, 7, and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start28 Feb 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Navy General Hospital, Beijing
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476742
- Sponsor's protocol ID
- PLAGH-RCT-taVNS-Cardiac
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium and Negative Emotional States in Patients Undergoing Cardiac Surgery: A Multicenter, Randomized, Double-Blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07476742
- Acronym / sponsor ID
- PLAGH-RCT-taVNS-Cardiac
- Conditions
- Postoperative Delirium (POD), Postoperative, Anxiety, Depression, Cardiac Surgical Procedures
- Keywords
- Transcutaneous Vagus Nerve Stimulation, Cardiac Surgery, Postoperative Delirium, Depression, Anxiety, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Navy General Hospital, Beijing
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 17 Mar 2026 (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.
A multicenter, randomized, double-blind, sham-controlled trial to investigate the effects of intraoperative transcutaneous auricular vagus nerve stimulation (taVNS) on the incidence of postoperative delirium and negative emotional states (anxiety, depression) in patients undergoing elective cardiac surgery.
Detailed description
Cardiac surgery is associated with a high risk of postoperative neurocognitive disorders, including delirium and negative emotional states such as anxiety and depression, which significantly impact patient recovery and long-term outcomes. This study aims to evaluate whether intraoperative taVNS, a non-invasive neuromodulation technique, can reduce the incidence and severity of these complications. Patients will be randomized to receive either active taVNS or sham stimulation during surgery. Outcomes including delirium, anxiety, depression, pain, sleep quality, recovery quality, and relevant biomarkers will be assessed postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active taVNS Group | Experimental | Device: Active taVNSPatients receiving active transcutaneous auricular vagus nerve stimulation during surgery. |
| Sham taVNS Group | Sham comparator | Device: Sham taVNS GroupPatients receiving sham (placebo) stimulation with an identical device during surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 to 85 years. Scheduled for elective cardiac surgery (e.g., CABG, valve replacement/repair). NYHA cardiac function class I-III. Willing and able to provide informed consent. Expected surgery duration ≥ 2 hours.
Key exclusion criteria (3 listed)
- Preoperative MMSE score < 24; severe communication barriers. History of diagnosed delirium, dementia, Parkinson's disease, schizophrenia, bipolar disorder, major depressive disorder, or long-term use of psychotropic drugs.
- Skin lesions, infection, or deformity of bilateral ears; history of ear surgery or nerve injury; allergy to electrode materials.
- Severe arrhythmia; implanted electronic devices (e.g., pacemaker, ICD). Participation in another interventional trial within 3 months. Other conditions deemed unsuitable by investigators.
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 |
|---|---|---|
| Active taVNSStimulation parameters: Amplitude 20 (mA), Frequency 20Hz, Pulse width 200μs, asymmetric biphasic square wave. The current is gradually increased from 10mA to a level slightly below the individual's "prickling" sensation threshold (20-60mA). Stimulation is applied to the left auricular concha for 30 minutes after anesthesia induction and for another 30 minutes after cardiopulmonary bypass weaning. | Device | Active taVNS Group |
| Sham taVNS GroupThe sham device is identical in appearance, weight, indicator lights, and operation sounds to the active device but delivers no effective electrical current. It is applied to the left auricular concha at the same time points as the active group (30 minutes after induction and 30 minutes after CPB weaning). | Device | Sham taVNS Group |
Primary outcome
Incidence of Postoperative Delirium
Time frame: Within 7 days after surgery
Postoperative delirium will be assessed using the 3-Minute Diagnostic Interview for CAM (3D-CAM) for general ward patients and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for ICU patients, from postoperative day 1 to day 7. Diagnosis requires the presence of acute onset/fluctuating course and inattention, plus either disorganized thinking or altered level of consciousness.
11 secondary outcomes
Incidence and Severity of Postoperative Depression
Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30
Incidence and Severity of Postoperative Anxiety
Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30
Incidence and Severity of Postoperative Depression
Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30
Incidence and Severity of Postoperative Anxiety (HADS-A)
Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30
Postoperative Agitation Score
Time frame: At the time of extubation (within 24 hours post-surgery)
Postoperative Nausea and Vomiting (PONV)
Time frame: Within 3 days after extubation
Postoperative Pain Score
Time frame: Postoperative day 1, 2, 3, 7, and 30
Postoperative Sleep Quality
Time frame: Postoperative day 1, 2, 3, 7, and 30
Postoperative Recovery Quality
Time frame: Postoperative day 7 and 30
Incidence and Severity of Postoperative Anxiety (GAD-7)
Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30
Incidence and Severity of Postoperative Anxiety (SAS)
Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30
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 17 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active taVNS in people with Postoperative Delirium (POD) and Postoperative, run by Chinese PLA General 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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Mar 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium (time frame: Within 7 days after surgery). 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 17 Mar 2026.