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רדאר קליני AI
הניסוי הקליני NCT07501611 עבור Vagus Nerve Stimulations הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים

Acute Cardiovascular Effects of Transcutaneous Auricular Vagus Nerve Stimulation 20 לא פולשני מחקר מוצלב מונע אורח חיים

טרם החל גיוס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07501611 הוא מחקר מסוג התערבותי עבור Vagus Nerve Stimulations, שנמצא במצב טרם החל גיוס. גיוס המשתתפים צפוי להתחיל ב-1 במרץ 2026, במטרה לכלול 20 משתתפים. המחקר ינוהל על ידי Northumbria University וצפוי להסתיים ב-1 בדצמבר 2027. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-30 במרץ 2026.
סיכום קצר
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 ...

הצג עוד
תיאור מפורט
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...הצג עוד
כותרת רשמית

Acute Cardiovascular Effects of Transcutaneous Auricular Vagus Nerve Stimulation

מצבים רפואיים
Vagus Nerve Stimulations
מזהי מחקר נוספים
  • 12026
מספר NCT
תחילת המחקר (בפועל)
2026-03-01
עדכון אחרון שפורסם
2026-03-30
סיום המחקר (מוערך)
2027-12-01
משתתפים (מתוכנן)
20
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
טרם החל גיוס
מילות מפתח
blood pressure
heart rate variability
מטרה ראשית
אחר
הקצאת טיפול
אקראי
דגם מתערב
מחקר מוצלב
עיוורון
כפול
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
ניסיActive 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...הצג עוד
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...הצג עוד
מדומה להשוואהSham 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...הצג עוד
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...הצג עוד
פלצבו להשוואהSham 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...הצג עוד
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...הצג עוד
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
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
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
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.
עוזר השתתפות
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
מתנדבים בריאים מתקבלים
כן

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
Northumbria University logoNorthumbria University
אין נתוני קשר.
1 מיקומי המחקר ב-1 מדינות
Northumbria University, Newcastle upon Tyne, United Kingdom
Gabriel Cucato, PhD, איש קשר, +44 0191 232 6002, [email protected]