Trial · NCT07891390
Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation
NCT07891390, Not applicable, Not yet recruiting, Centre Hospitalier Universitaire de Saint Etienne
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation. Trials, record NCT07891390. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07891390
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation
- NCT number
- NCT07891390
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 64 participants, estimated
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Conditions
- Atrial Fibrillation (AF), Cerebral Vascular Accident (CVA), Heart Failure, Myocardial Infarction (MI)
- Interventions
- tVNS session on the left earlobe, tVNS "SHAM" session the conchae aurea of the left ear
- First posted
- 2026-10-23
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in RMSSD of Heart Rate Variability After the Last tVNS Session | 15 days | RMSSD (ms), a measure of parasympathetic cardiac activity, will be measured from HRV recordings (Holter 24h). Recordings will be made before the first session and after the last session of transcutaneous auricular vagus nerve stimulation (tVNS), delivered for 1 to 2 hours per day during the preoperative period. A higher RMSSD indicates greater parasympathetic activity. The outcome is the change in RMSSD from baseline to after the last session. |
| Secondary | Cardiac autonomic activity | 3 months | Cardiac autonomic activity, as measured by HRV, will be assessed postoperatively using the RMSSD parameter (ms). |
| Secondary | Blood Concentrations of Inflammatory Biomarkers | 3 months | Inflammatory activity will be assessed from blood concentrations of C-reactive protein (CRP, mg/L), fibrinogen (g/L) and ferritin (µg/L), measured in routine care blood samples. One blood tube per participant will be stored for retrospective complementary analyses of cytokines (TNF-α, IL-6, IL-1, IL-10, IL-17; pg/mL). |
| Secondary | Inflammatory Biomarkers in Aortic Valve Tissue, Assessed by Immunohistochemistry | 3 months | Inflammatory activity will be assessed using inflammatory biomarkers in aortic valve tissue, analyzed by immunohistochemistry. Results are reported as the quantification of marker-positive staining |
| Secondary | The quality of postoperative recovery | 3 months | The quality of postoperative recovery will be assessed using the Quality-Of-Recovery-15 (QoR-15) questionnaire (scores range from 0 to 150; higher scores indicate better recovery) |
| Secondary | Adherence | 45 days | Total duration of transcutaneous auricular vagus nerve stimulation (tVNS) actually delivered, calculated as the total of the daily stimulation durations over all days on which stimulation was completed, as recorded by the participant in a tracking log. A single value is reported per participant, expressed in minutes. |
| Secondary | The Feasibility indicators | 3 months | Feasibility indicators will include the eligibility rate, the inclusion rate, the refusal rate, and the 3-month follow-up rate. Satisfaction will be assessed using an overall satisfaction scale (a 1-to-5 Likert scale). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07891390
GET https://conductscience.org/api/trials/v1/NCT07891390/registered