Clinical Research Directory
Browse clinical research sites, groups, and studies.
Frequency-Dependent Effects of Auricular Vagus Nerve Stimulation on Autonomic and Cardiovascular Parameters
Sponsor: SEFA HAKTAN HATIK
Summary
This randomized, sham-controlled, crossover study investigates the acute autonomic effects of transcutaneous cervical vagus nerve stimulation (tcVNS) applied at five different frequencies (0 Hz/sham, 10 Hz, 25 Hz, 50 Hz, 100 Hz) in healthy adults. The primary objective is to determine how stimulation frequency modulates heart rate variability (HRV), blood pressure, and respiratory rate. The study aims to establish a frequency-specific dose-response model using validated physiological measurements.
Official title: Acute Effects of Different Frequencies of Auricular Vagus Nerve Stimulation on HRV, Blood Pressure, and Respiratory Rate: A Sham-Controlled, Randomized, Crossover Dose-Response Study
Key Details
Gender
All
Age Range
18 Years - 30 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2025-12-22
Completion Date
2026-03-15
Last Updated
2025-12-10
Healthy Volunteers
Yes
Conditions
Interventions
Pulsetto FIT™ - Sham tcVNS
The Pulsetto FIT™ device is placed bilaterally on the cervical region (posterior margin of the sternocleidomastoid muscle). In the sham condition, the device displays normal operational lights but delivers no electrical stimulation (0 Hz; inactive mode). This condition is used for blinding and as the control comparator. Dose: 10 minutes
Pulsetto FIT™ - tcVNS 10 Hz
Bilateral transcutaneous cervical vagus nerve stimulation delivered via the Pulsetto FIT™ device at 10 Hz, 250 µs pulse width. Current intensity adjusted to a mild, non-painful tingling sensation, individualized for each participant. Dose: 10 minutes
Pulsetto FIT™ - tcVNS 25 Hz
Bilateral tcVNS using the Pulsetto FIT™ device at 25 Hz, 250 µs pulse width. Stimulation intensity set at a comfortable sensory level. Dose: 10 minutes
Pulsetto FIT™ - tcVNS 50 Hz
Bilateral cervical vagus nerve stimulation via Pulsetto FIT™ at 50 Hz, 250 µs pulse width. Intensity adjusted to a tolerable sensory level without discomfort. Dose: 10 minutes
Pulsetto FIT™ - tcVNS 100 Hz
Bilateral tcVNS delivered with the Pulsetto FIT™ device at 100 Hz, 250 µs pulse width. Highest stimulation frequency used in this protocol; current intensity individualized per participant comfort. Dose: 10 minutes
Locations (1)
Sinop University, Türkeli Vocational School (Türkeli MYO)
Türkeli, Sinop, Turkey (Türkiye)