Neuromodulation to improve patient recovery after coronary artery bypass grafting
| ISRCTN | ISRCTN18258415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18258415 |
| Swissethics BASEC ID | 2025-D0083 |
| Sponsor | Hôpitaux Universitaires de Genève (HUG) |
| Funder | Hôpitaux Universitaires de Genève (HUG) |
- Submission date
- 13/11/2025
- Registration date
- 13/11/2025
- Last edited
- 13/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Neuromodulation with auricular vagal nerve therapy (AVNT) is a method known to help promote relaxation and offers many benefits related to reduced anxiety and pain. This method has been tested in various patient populations, including patients with heart conditions. Studies indicated that AVNT reduces inflammation, helps improve heart rhythm disorders, and it is largely safe. In this study, we will evaluate if neuromodulation therapy delivered with the Nurosym device decreases the postoperative atrial fibrillation rates and burden and aids patient recovery after cardiac surgery.
Who can participate?
Adult patients undergoing elective on-pump isolated CABG surgery.
What does the study involve?
The participants in the intervention group will receive AVNT adjunct to standard of care preoperatively (1h), intraoperatively (1h), and postoperatively (7h daily) until the postoperative day 4. The participants in the control group will receive sham treatment (null current through the device), adjunct to standard of care.
What are the possible benefits and risks of participating?
The intervention poses none or minimal risks for participants. Participants in the intervention group will potentially benefit from improved recovery.
Where is the study run from?
Geneva University Hospitals (HUG) (Switzerland)
When is the study starting and how long is it expected to run for?
01 February 2025 – 01 May 2028
Who is funding the study?
Geneva University Hospitals (HUG) (Switzerland)
Who is the main contact?
Professor Christoph HUBER
Head of Cardiovascular Surgery Division
Geneva University Hospitals (HUG)
Rue Gabrielle-Perret Gentile 4
Geneva, 1205 CH
e-mail: christoph.huber@hug.ch
Contact information
Principal investigator, Scientific
Rue Gabrielle-Perret Gentil 4
Geneva
1205
Switzerland
 ORCID ID |
0000-0001-9048-849X |
|---|---|
| Phone | 0041 22 372 76 25 |
| christoph.huber@hug.ch |
Scientific, Principal investigator
Rue Gabrielle-Perret Gentil 4
Geneva
1205
Switzerland
| Phone | 0041 22 372 74 46 |
|---|---|
| karim.bendjelid@hug.ch |
Scientific, Principal investigator
Rue Gabrielle-Perret Gentil 4
Geneva
1205 CH
Switzerland
| Phone | 0041 22 372 30 63 |
|---|---|
| Bernardo.BollenPinto@hug.ch |
Public
Rue Gabrielle-Perret Gentil 4
Geneva
1205
Switzerland
| Phone | 0041795539870 |
|---|---|
| Daniela.DumitriuLagrange@unige.ch |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | Parallel | |
| Purpose | Prevention, Treatment | |
| Scientific title | Auricular vagal neuromodulation therapy (AVNT) with Nurosym for preventing postoperative atrial fibrillation, decreasing inflammatory responses, and improving patient recovery following CABG – a randomized controlled trial | |
| Study acronym | AVNT_CABG | |
| Study objectives | Primary objective: Ascertain if auricular vagal neuromodulation therapy (AVNT), adjunct to standard of care, reduces the rate of postoperative atrial fibrillation (POAF) following coronary artery bypass graft (CABG) surgery Secondary objectives: to determine if AVNT adjunct to standard of care -is decreasing the POAF burden, -improves inflammatory profile, -shortens the length of ICU and hospital stay, -increases patient comfort, by decreasing the levels of pain, preventing nausea/vomiting, and decreasing the psychological stress. | |
| Ethics approval(s) |
Submitted 10/09/2025, Swissethics CCER (Commission cantonale d'éthique de la recherche) Geneva (Rue Adrien-Lachenal 8, Geneva, 1207, Switzerland; 0041 22 546 51 01; ccer@etat.ge.ch), ref: 2025-D0083 | |
| Health condition(s) or problem(s) studied | Postoperative atrial fibrillation, following cardiac surgery, pain, stress | |
| Intervention | Assignment to each of the two parallel arms will be performed based on a stratified block randomization scheme, with a stratum assigned to each sex (male/female), and a small block size (block size = 4). The randomization scheme will be generated in R (eg. “blockrand” package) and uploaded in REDCap. The assignment to experimental/control arms will be performed automatically for each new participant entry in REDcap. The randomization scheme will be concealed to the REDCap data entry user. The intervention consists in AVNT with Nurosym device adjunct to standard of care : 1 h preoperatively, 1h intraoperatively, and 7h daily starting from their arrival in ICU or intermediate care (the day of surgery, day 0) and until postoperative day 4, with even exposure between the left and right ear. The comparator will be sham (null current delivered by the electrode attached to tragus) adjunct to standard of care. | |
| Intervention type | Device | |
| Phase | Phase II | |
| Drug / device / biological / vaccine name(s) | Nurosym (Parasym) | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 01/07/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | All |
| Target sample size at registration | 110 |
| Key inclusion criteria | 1. Age 18 years old or older 2. Undergoing elective on-pump isolated CABG |
| Key exclusion criteria | 1. History of atrial fibrillation or atrial flutter before CABG 2. Preoperative sinus node dysfunction, atrioventricular block, severe bradycardia, heart valve disease 3. Undergoing CABG combined with another type of surgery 4. Permanent pacemaker before surgery 5. Off-pump CABG 6. Undergoing urgent or emergency surgery 7. Contraindications and limitations of the Nurosym device: - Cervical vagotomy - Permanent metallic/electronic device (e.g., cochlear implants) or jewellery in close proximity to ear tragus - Pregnant women - Cerebral shunts - Invasive vagus nerve stimulators - Non-active metal implants potentially interacting with the nervous system (e.g., metallic spinal implants) - Lesions (e.g., cracked skin or wounds) on the tragus 8. Vulnerable subjects (e.g., prisoners) 9. Inability of the subject to consent or to follow the procedures of the investigation (e.g., due to language problems, psychological disorders, etc.) |
| Date of first enrolment | 01/02/2026 |
| Date of final enrolment | 01/05/2028 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Geneva
1205 CH
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
13/11/2025: Trial's existence confirmed by Swissethics.
