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NOT YET RECRUITING
NCT07526415
NA

Effect of Recording Duration on Heart Rate Variability During taVNS

Sponsor: Sinop University

View on ClinicalTrials.gov

Summary

This study aims to evaluate how different heart rate variability (HRV) recording durations reflect autonomic nervous system responses during transcutaneous auricular vagus nerve stimulation (taVNS) in healthy adults. In a randomized, sham-controlled crossover design, participants will attend two separate sessions and receive both active taVNS and sham stimulation in randomized order. During each session, a continuous 10-minute HRV recording will be obtained, and 1-minute, 5-minute, and 10-minute analysis windows will be compared. Blood pressure and pulse will also be measured before and after stimulation. The study will investigate whether shorter or longer HRV recording durations provide results comparable to the standard 5-minute recording and which duration most reliably detects autonomic changes during taVNS.

Official title: Effect of Recording Duration on Heart Rate Variability During Transcutaneous Auricular Vagus Nerve Stimulation: A Randomized, Sham-Controlled Crossover Study

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-05-01

Completion Date

2026-09-15

Last Updated

2026-04-16

Healthy Volunteers

Yes

Interventions

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

Active transcutaneous auricular vagus nerve stimulation will be applied bilaterally to the cymba conchae region of the ear using a transcutaneous stimulation device. Stimulation will be delivered for 10 minutes with a frequency of 25 Hz, a pulse width of 200 to 300 microseconds, and an individually adjusted intensity that is clearly perceptible but not painful. Heart rate variability will be recorded continuously during the intervention.

DEVICE

Sham Stimulation

Sham stimulation will be delivered for 10 minutes using the same transcutaneous stimulation device and similar stimulation settings as the active intervention, but the stimulation will be applied to a non-vagal ear region, such as the earlobe or helix, to minimize physiologic vagal effects while maintaining similar sensory input. Heart rate variability will be recorded continuously during the intervention.

Locations (1)

Artvin Coruh University, Artvin Vocational School, Disabled Care and Rehabilitation Laboratory, Artvin,

Artvin, Turkey (Türkiye)