Frequency-Dependent Effects of Auricular Vagus Nerve Stimulation on Autonomic and Cardiovascular Parameters
NCT ID: NCT07274332
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2025-12-22
2026-03-15
Brief Summary
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Detailed Description
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This crossover trial randomizes participants to receive five stimulation conditions (sham, 10 Hz, 25 Hz, 50 Hz, 100 Hz) in counterbalanced order. HRV (Polar H10), blood pressure (Omron), and respiratory rate (Kinovea-based thoracoabdominal video tracking) are collected pre- and post-stimulation. Washout between sessions is ≥48 hours.
The study provides one of the first systematic evaluations of frequency-dependent tcVNS effects in healthy adults.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
The investigator administering the stimulation is aware of the condition due to device programming requirements.
Study Groups
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1 - Sham (0 Hz)
Intervention Type: Pulsetto FIT™ tcVNS Device Intervention Name: Sham tcVNS Description: Device placed on bilateral cervical region; no electrical current delivered.
Dose: 10 minutes
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
2 - 10 Hz tcVNS
Intervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (10 Hz) Description: Bilateral cervical stimulation at 10 Hz, 250 μs pulse width. Duration: 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
3 - tcVNS 25 Hz
Intervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (25 Hz) Description: Bilateral cervical stimulation at 25 Hz, 250 μs pulse width. Duration: 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
4 - tcVNS 50 Hz
Intervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (50 Hz) Description: Bilateral cervical stimulation at 50 Hz, 250 μs pulse width. Duration: 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
5 - tcVNS 100 Hz
Intervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (100 Hz) Description: Bilateral cervical stimulation at 100 Hz, 250 μs pulse width. Duration: 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Healthy (self-reported)
* No cardiovascular, neurological, metabolic or psychiatric disorders
* No regular medication affecting autonomic function
* Non-smoker
* BMI 18-29.9
Exclusion Criteria
* Cardiac arrhythmia
* Hypertension or hypotension
* Chronic respiratory disorders
* Active infection
* Metal implants in cervical area
* Epilepsy
* Syncope history
* Prior vagus stimulation experience
18 Years
30 Years
ALL
Yes
Sponsors
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SEFA HAKTAN HATIK
OTHER
Responsible Party
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SEFA HAKTAN HATIK
Assistant Professor
Locations
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Sinop University, Türkeli Vocational School (Türkeli MYO)
Türkeli, Sinop, Turkey (Türkiye)
Countries
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References
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Kranz S, Lukacs J, Bishop J, Block ME. Intergeneration transfer of diet patterns? Parental self-report of diet and their report of their young adult children with ASD. PLoS One. 2022 Feb 8;17(2):e0263445. doi: 10.1371/journal.pone.0263445. eCollection 2022.
Alsoufi B. Curb Your Enthusiasm for the Ozaki Procedure in Small Children. Ann Thorac Surg. 2022 Jan;113(1):378-379. doi: 10.1016/j.athoracsur.2021.03.085. Epub 2021 Apr 8. No abstract available.
Nordahl HM, Wells A. Metacognitive Therapy of Early Traumatized Patients With Borderline Personality Disorder: A Phase-II Baseline Controlled Trial. Front Psychol. 2019 Jul 30;10:1694. doi: 10.3389/fpsyg.2019.01694. eCollection 2019.
Peuker ET, Filler TJ. The nerve supply of the human auricle. Clin Anat. 2002 Jan;15(1):35-7. doi: 10.1002/ca.1089.
Grossman P, Taylor EW. Toward understanding respiratory sinus arrhythmia: relations to cardiac vagal tone, evolution and biobehavioral functions. Biol Psychol. 2007 Feb;74(2):263-85. doi: 10.1016/j.biopsycho.2005.11.014. Epub 2006 Nov 1.
Zhang Y, Xiao S, Feng H, Zhang L, Zhou Z, Hu W. Self-interference cancellation using dual-drive Mach-Zehnder modulator for in-band full-duplex radio-over-fiber system. Opt Express. 2015 Dec 28;23(26):33205-13. doi: 10.1364/OE.23.033205.
Fernandes TL, Viezzer Fernandes B, Jitumori C, Franco GCN. A Case Report of Oral Bisphosphonate Treatment for Osteoporosis Leading to Atypical Femoral Fracture and Pathologic Mandibular Fracture. Am J Case Rep. 2023 Oct 23;24:e941144. doi: 10.12659/AJCR.941144.
Other Identifiers
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tcVNS1
Identifier Type: -
Identifier Source: org_study_id
IRB Number (Pending)
Identifier Type: REGISTRY
Identifier Source: secondary_id
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