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Acute Cardiovascular Effects of Transcutaneous Auricular Vagus Nerve Stimulation 20 Non-Invasive Crossover Design Preventive Lifestyle
Clinical Trial NCT07501611 is an interventional study for Vagus Nerve Stimulations and is currently not yet recruiting. Enrollment is planned to begin on March 1, 2026 and continue until the study accrues 20 participants. Led by Northumbria University, this study is expected to complete by December 1, 2027. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief Summary
Introduction
Cardiovascular disease (CVD) remains the leading cause of mortality worldwide, with arterial hypertension representing the most significant modifiable risk factor (Lim et al., 2012; Mills et al., 2020). While clinical manifestations of arterial hypertension typically emerge in later life, the underlying pathophysiological mechanisms, particularly autonomic dysfunction, begin decades earlier.
Autonomic ...
Show MoreDetailed Description
Before study commencement, the complete randomisation sequence for all 20 participants will be generated using the online random sequence generator available at www.randomizer.org. An independent researcher who is not involved in participant recruitment, screening, data collection, or outcome assessment will use the "Randomise Lists" function to generate 20 distinct randomised orders of the three experimental conditi...Show More
Official Title
Acute Cardiovascular Effects of Transcutaneous Auricular Vagus Nerve Stimulation
Conditions
Vagus Nerve StimulationsOther Study IDs
- 12026
NCT ID Number
Start Date (Actual)
2026-03-01
Last Update Posted
2026-03-30
Completion Date (Estimated)
2027-12-01
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
blood pressure
heart rate variability
heart rate variability
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalActive stimulation session For the active taVNS condition, the Parasym taVNS system (Parasym Health, London, United Kingdom) will be used. This device delivers transcutaneous electrical stimulation to the auricular branch of the vagus nerve via a surface electrode placed on the left tragus. The stimulation consists of a proprietary waveform comprising micro-pulses with a pulse width of 200 microseconds delivered at a frequency of 20 Hertz. Bef...Show More | Active taVNS condition For the active taVNS condition, the Parasym taVNS system (Parasym Health, London, United Kingdom) will be used. This device delivers transcutaneous electrical stimulation to the auricular branch of the vagus nerve via a surface electrode placed on the left tragus. The stimulation consists of a proprietary waveform comprising micro-pulses with a pulse width of 200 microseconds delivered at a frequency of 20 Hertz. Bef...Show More |
Sham ComparatorSham sound condition For the sham-sound condition, participants will be asked to adjust the device settings to mimic the intensity range used during the active protocol (Levels 13 to 20), ensuring that the setup procedure and user actions feel identical across sessions. However, in this mode, the device does not deliver any therapeutic electrical stimulation. Instead, a sham electrode, identical in appearance to the active electrode, pro...Show More | Sham-sound condition For the sham-sound condition, participants will be asked to adjust the device settings to mimic the intensity range used during the active protocol (Levels 13 to 20), ensuring that the setup procedure and user actions feel identical across sessions. However, in this mode, the device does not deliver any therapeutic electrical stimulation. Instead, a sham electrode, identical in appearance to the active electrode, pro...Show More |
Placebo ComparatorSham mode condition For the sub-threshold sham condition, the Parasym device will be switched into its sham mode and set to Level 5, which delivers stimulation intentionally kept below the sensory threshold. Participants will be informed at the beginning of this session: "In this session, the stimulation will be delivered below the sensory threshold, meaning the intensity is very low and you should not feel any sensation. Please confirm...Show More | Sham Mode For the sub-threshold sham condition, the Parasym device will be switched into its sham mode and set to Level 5, which delivers stimulation intentionally kept below the sensory threshold. Participants will be informed at the beginning of this session: "In this session, the stimulation will be delivered below the sensory threshold, meaning the intensity is very low and you should not feel any sensation. Please confirm...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Blood Pressure (office) | Auscultatory BP measurements will be obtained using a calibrated mercury sphygmomanometer and stethoscope applied to the participant's dominant arm. Systolic BP will be identified at the appearance of the first clear tapping sound (Korotkoff phase I), and diastolic BP will be identified at the disappearance of sounds (Korotkoff phase V). The same experienced evaluator, who remains blinded to condition allocation, will perform all auscultatory measurements throughout the study to minimise inter-observer variability. | pre intervention and 15, 30, 45 and 60 min post-intervention |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Continuous beat-to-beat Blood Pressure | Continuous beat-to-beat BP will be measured using the Finapres NOVA non-invasive finger arterial pressure monitor. All measurements will be obtained with the participant in the supine position, with the measurement arm supported at heart level to ensure hydrostatic equivalence between the finger and the heart. A finger cuff will be placed on either the index or middle finger of the non-dominant arm, selected based on optimal signal quality, and a brachial calibration cuff will be positioned on the upper arm of the same limb. Data will be exported at a sampling frequency of 200 Hz, providing systolic, diastolic, and mean arterial pressures, pulse pressure, and heart rate for each cardiac cycle | pre-intervention and post-intervention (during all 60 min post-intervention) |
Heart Rate and Heart Rate Variability | Heart rate will be monitored continuously using the Polar Unite optical sensor, which uses photoplethysmography to derive heart rate and inter-beat intervals from changes in wrist blood volume. The device will be worn on the dominant wrist and record second-by-second heart rate and high-resolution interval data. HRV analysis will use two stable resting segments: the final 10 minutes of baseline and minutes 50-60 of recovery. Inter-beat intervals will be exported to Kubios HRV Premium for processing. Data will be visually inspected, with artefacts detected at a 0.3-second threshold and corrected via cubic spline interpolation; segments with \>5% corrections or \<5 minutes of valid data will be excluded. HRV parameters will follow Task Force standards. | Pre-intervention and minutes 50-60 of post-intervention. |
Cardiac Output | Cardiac output will be estimated using the Modelflow algorithm integrated into the Finapres NOVA system. | Pre-intervention and post-intervention (during all 60 min post-intervention) |
Stroke Volume | Stroke volume will be calculated as cardiac output divided by heart rate, then multiplied by 1000 to express it in millilitres | Pre-intervention and post-intervention (during all 60 min post-intervention) |
Total peripheral resistance | Total peripheral resistance will be calculated as mean arterial pressure divided by cardiac output, expressed in millilitres of mercury per minute per litre. | pre-intervention and post-intervention (during all 60 min post-intervention) |
Baroreflex Sensitivity | Baroreflex sensitivity will be assessed during the same time periods used for heart rate variability analysis: the final 10 minutes of pre-intervention baseline and minutes 50 through 60 of post-intervention recovery. The baroreflex sensitivity will be assessed non-invasively using the sequence method applied to synchronised beat-to-beat BP and inter-beat interval data. This technique identifies spontaneous sequences of consecutive cardiac cycles in which progressive increases or decreases in systolic BP are coupled with corresponding changes in inter-beat interval duration, reflecting the baroreflex-mediated heart rate response to BP fluctuations. Data for this analysis will be obtained by synchronising the continuous systolic BP values from the Finapres system with the inter-beat interval data from the Polar Unite sensor. | Pre-intervention and minutes 50-60 of post-intervention. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
Participants will be eligible if they meet the following criteria:
- Age: 18-45 years
- Healthy status: No diagnosed cardiovascular, metabolic, neurological, or psychiatric conditions
- BP: Normotensive (office SBP <140 mmHg and DBP <90 mmHg)
- Body Mass Index (BMI): 18.5-30 kg/m²Non-smoker or light smoker (≤5 cigarettes per day, willing to abstain before testing)
- Ability to understand and provide written informed consent
- Willingness to comply with study procedures, including:
- No regular use of medications affecting cardiovascular or autonomic function (including beta-blockers, calcium channel blockers, antihypertensives, or psychotropic medications)
- Current participation in another interventional trial
- Clinically significant resting bradycardia (HR <50 bpm)
- Known damage or surgical removal of the vagus nerve
- Established cardiovascular disease (e.g., myocardial infarction, heart failure, arrhythmias, stroke, peripheral vascular disease)
- Diagnosed with hypertension or currently taking antihypertensive medication
- Known diagnosis of trigeminal neuralgia or other chronic pain conditions
- Active ear infection or skin conditions affecting the tragus/auricle
- Implanted electronic devices (pacemaker, defibrillator, vagal nerve stimulator)
- Pregnancy or breastfeeding
- Current diagnosis of anxiety, depression, or other psychiatric conditions requiring medication
- History of syncope or severe vasovagal response
No contact data.
1 Study Locations in 1 Countries
Northumbria University, Newcastle upon Tyne, United Kingdom
Gabriel Cucato, PhD, Contact, +44 0191 232 6002, [email protected]