Health TrialsbyHealthPanel

Effect of Recording Duration on Heart Rate Variability During taVNS

ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorSinop University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy volunteers aged 18 to 40 years

Able and willing to provide informed consent

Able to tolerate active transcutaneous auricular vagus nerve stimulation and sham stimulation

Able to comply with study instructions, including restrictions related to caffeine, nicotine, and heavy exercise before assessment

Disqualifiers

Diagnosed cardiovascular disease, arrhythmia, or pacemaker use

History of neurologic disease that may affect autonomic nervous system function

Regular use of medications that may affect heart rate variability or autonomic responses, including beta blockers, antiarrhythmics, or anticholinergic drugs

Active ear infection, dermatologic lesion, or any ear condition that may interfere with stimulation

Trial design

Design model

Crossover

Treatments tested in this trial

  • Transcutaneous Auricular Vagus Nerve Stimulation

    Device

    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.

  • Sham Stimulation

    Device

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: taVNS FirstExperimental treatment 1 intervention
Group B: Sham FirstSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Difference in 5-minute lnRMSSD During Active taVNS Compared With Sham Stimulation

The primary outcome is the between-condition difference in 5-minute heart rate variability, assessed by lnRMSSD derived from the continuous RR interval recording obtained during the 10-minute intervention period. The 5-minute analysis window is the prespecified standard short-term HRV measure used to compare active transcutaneous auricular vagus nerve stimulation with sham stimulation.

Time frame
During the 10-minute intervention period at each study session

Secondary outcomes

1

Agreement Between 1-minute and 5-minute HRV Measurements During Active taVNS

Agreement between ultra-short 1-minute and standard 5-minute HRV measurements obtained from the same continuous RR recording during active taVNS will be assessed using predefined agreement analyses.

Time frame
During the 10-minute intervention period at each active taVNS session
2

Comparison of 10-minute and 5-minute HRV Measurements During Active taVNS

HRV parameters derived from 10-minute and 5-minute analysis windows of the same continuous RR recording during active taVNS will be compared to determine whether the longer recording provides additional physiologic sensitivity or discriminatory value.

Time frame
During the 10-minute intervention period at each active taVNS session
3

Effect of Recording Duration on HRV Differences Between Active taVNS and Sham Stimulation

Differences between active taVNS and sham stimulation will be evaluated across 1-minute, 5-minute, and 10-minute HRV analysis windows to determine whether recording duration influences the detection of autonomic effects.

Time frame
During the 10-minute intervention period at each study session
4

Change in Systolic and Diastolic Blood Pressure After Active taVNS Compared With Sham Stimulation

Systolic and diastolic blood pressure will be measured before and immediately after each intervention session to assess hemodynamic responses to active taVNS and sham stimulation.

Time frame
Immediately before and immediately after each 10-minute intervention session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sinop University

Lead sponsor

Source ClinicalTrials.gov

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