Vagus Nerve StimulationAVNS-DRCNCT07274332

Frequency-Dependent Effects of Auricular Vagus Nerve Stimulation on Autonomic and Cardiovascular Parameters

A study testing Pulsetto FIT™ - tcVNS 10 Hz, Pulsetto FIT™ - tcVNS 25 Hz and Pulsetto FIT™ - tcVNS 50 Hz in people with Vagus Nerve Stimulation and Autonomic Nervous System, run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Vagus Nerve Stimulation, Autonomic Nervous System, Heart Rate
What is being tested?: Pulsetto FIT™ - tcVNS 10 Hz, Pulsetto FIT™ - tcVNS 25 Hz and Pulsetto FIT™ - tcVNS 50 Hz
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 22 Dec 2025to 15 Mar 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

18-30 years
Healthy (self-reported)
No cardiovascular, neurological, metabolic or psychiatric disorders
No regular medication affecting autonomic function
Non-smoker
BMI 18-29.9

Who cannot join

Pregnancy
Cardiac arrhythmia
Hypertension or hypotension
Chronic respiratory disorders
Active infection
Metal implants in cervical area

Show all 9Show fewer

Epilepsy
Syncope history
Prior vagus stimulation experience

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site

Sinop University, Türkeli Vocational School (Türkeli MYO)
Türkeli, Sinop, 57900

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed description

Transcutaneous cervical vagus nerve stimulation (tcVNS) is a non-invasive neuromodulation technique capable of activating afferent vagal pathways projecting to autonomic brainstem nuclei. Although previous studies demonstrate tcVNS-related modulation of autonomic functions, the frequency-response relationship remains insufficiently explored.

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: Vagus Nerve Stimulation, Autonomic Nervous System, Heart Rate, Blood Pressure, Respiration, Healthy Volunteers
Being tested: Pulsetto FIT™ - Sham tcVNS, Pulsetto FIT™ - tcVNS 10 Hz, Pulsetto FIT™ - tcVNS 25 Hz, Pulsetto FIT™ - tcVNS 50 Hz, Pulsetto FIT™ - tcVNS 100 Hz
Keywords: Transcutaneous Cervical Vagus Nerve Stimulation, Neuromodulation, Non-invasive Vagus Stimulation, Parasympathetic Activation, Heart Rate Variability
Medical subject headings: Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pulsetto FIT™ - Sham tcVNSDevice
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 HzDevice
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 HzDevice
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 HzDevice
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 HzDevice
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

Study groups in NCT07274332
Study group	Role	What they receive
1 - Sham (0 Hz)	Sham comparator	Intervention Type: Pulsetto FIT™ tcVNS Device Intervention Name: Sham tcVNS Description: Device placed on bilateral cervical region; no electrical current delivered. Dose: 10 minutes Receives: Device: Pulsetto FIT™ - Sham tcVNS
2 - 10 Hz tcVNS	Experimental	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 Receives: Device: Pulsetto FIT™ - tcVNS 10 Hz
3 - tcVNS 25 Hz	Experimental	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 Receives: Device: Pulsetto FIT™ - tcVNS 25 Hz
4 - tcVNS 50 Hz	Experimental	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 Receives: Device: Pulsetto FIT™ - tcVNS 50 Hz
5 - tcVNS 100 Hz	Experimental	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 Receives: Device: Pulsetto FIT™ - tcVNS 100 Hz

What is being measured

The primary outcome is the main question the study is designed to answer.

Heart Rate Variability (HRV) Changes (ΔRMSSD, ΔHF, ΔLF/HF)
HRV is recorded using a validated high-resolution heart rate monitor (Polar H10) during a 5-minute resting baseline (T0) and a 5-minute post-stimulation period (T2).
The following time- and frequency-domain parameters are analyzed: RMSSD, HF (ms²), and LF/HF ratio.
Artefact correction is performed using standard HRV processing methods. Acute autonomic response is quantified by calculating change scores (Δ = post-pre) for each stimulation frequency.
Measured: Pre- vs Post-stimulation (5-min segments)(5-minute baseline, 5-minute stimulation, 5-minute post period)

Secondary outcomes (3)

Blood Pressure (SBP, DBP, MAP)
Two readings are taken at each time point from the right arm with a validated automatic sphygmomanometer, and the average systolic, diastolic, and mean arterial pressure values are used for analysis.
Changes are calculated as post-pre (Δ values) to assess the acute physiological effect of each stimulation frequency..
Measured: Pre- vs Post-stimulation (5-minute baseline, 5-minute stimulation, 5-minute post period)
Respiratory Rate (breaths per minute)
Respiratory rate is assessed by video-based thoracoabdominal motion tracking at baseline (T0) and after stimulation (T2).
Videos are analyzed using Kinovea motion-tracking software, and a 1-minute stable segment is used to determine breaths per minute by counting inspiratory peaks.
Respiratory changes are expressed as Δ values (post-pre) to account for individual differences and improve HRV interpretability.Respiratory rate is assessed by video-based thoracoabdominal motion tracking at baseline (T0) and after stimulation (T2).
Videos are analyzed using Kinovea motion-tracking software, and a 1-minute stable segment is used to determine breaths per minute by counting inspiratory peaks.
Respiratory changes are expressed as Δ values (post-pre) to account for individual differences and improve HRV interpretability.
Measured: Pre- vs Post-stimulation (5-minute video segments) (5-minute baseline, 5-minute stimulation, 5-minute post period)
Discomfort Level (Visual Analog Scale, 0-10)
Participants report their perceived discomfort level at baseline (T0) and immediately after stimulation (T2) using a 0-10 Visual Analog Scale (VAS).
The scale captures any sensory discomfort associated with tcVNS. Changes are calculated by subtracting the pre-stimulation score from the post-stimulation score (ΔVAS).
Measured: Pre- vs Post-stimulation (5-minute baseline, 5-minute stimulation, 5-minute post period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Dec 202515 Mar 2026

First posted10 Dec 2025
Study start22 Dec 2025 (estimated)
Primary completion31 Jan 2026 (estimated)
Study completion15 Mar 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Vagus Nerve StimulationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: All participants receive each of the five stimulation conditions in randomized counterbalanced order (Williams Latin Square). Each visit includes a 10-minute tcVNS session and before/after physiological recordings. Washout between visits is ≥48 hours.
Masking: Single blind
Who is masked: Participant
Enrolment: 36 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07274332
Sponsor's protocol ID: tcVNS1
Other IDs: IRB Number (Pending)
Acronym: AVNS-DRC
Status last verified: Nov 2025
First submitted: 27 Nov 2025
Last updated: 10 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared because the study includes physiological recordings (HRV, blood pressure, respiratory videos) that cannot be fully anonymized. Data sharing may pose a risk of indirect identification. Only aggregated results will be reported in publications and presentations. IPD Sharing Time Frame: Not applicable. IPD Sharing Access Criteria: Not applicable.

Publications

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.
PubMed 35134082
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.
PubMed 33839137
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.
PubMed 31417453
Peuker ET, Filler TJ. The nerve supply of the human auricle. Clin Anat. 2002 Jan;15(1):35-7. doi: 10.1002/ca.1089.
PubMed 11835542
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.
PubMed 17081672
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.
PubMed 26831988
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.
PubMed 37867315

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Chronic Kidney Disease
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy

All Vagus Nerve Stimulation trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07274332
Acronym / sponsor ID: AVNS-DRC / tcVNS1
Conditions: Vagus Nerve Stimulation, Autonomic Nervous System, Heart Rate, Blood Pressure, Respiration, Healthy Volunteers
Keywords: Transcutaneous Cervical Vagus Nerve Stimulation, Neuromodulation, Non-invasive Vagus Stimulation, Parasympathetic Activation, Heart Rate Variability
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 36 participants (estimated)
Lead sponsor: SEFA HAKTAN HATIKUniversity, hospital or other
Study start: 22 Dec 2025 (estimated)
Primary completion: 31 Jan 2026 (estimated)
Study completion: 15 Mar 2026 (estimated)
First posted: 10 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study provides one of the first systematic evaluations of frequency-dependent tcVNS effects in healthy adults.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 5
Model description: All participants receive each of the five stimulation conditions in randomized counterbalanced order (Williams Latin Square). Each visit includes a 10-minute tcVNS session and before/after physiological recordings. Washout between visits is ≥48 hours.

Arm	Type	Receives
1 - Sham (0 Hz)	Sham comparator	Device: Pulsetto FIT™ - Sham tcVNSIntervention Type: Pulsetto FIT™ tcVNS Device Intervention Name: Sham tcVNS Description: Device placed on bilateral cervical region; no electrical current delivered. Dose: 10 minutes
2 - 10 Hz tcVNS	Experimental	Device: Pulsetto FIT™ - tcVNS 10 HzIntervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (10 Hz) Description: Bilateral cervical stimulation at 10 Hz, 250 μs pulse width. Duration: 10 minutes
3 - tcVNS 25 Hz	Experimental	Device: Pulsetto FIT™ - tcVNS 25 HzIntervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (25 Hz) Description: Bilateral cervical stimulation at 25 Hz, 250 μs pulse width. Duration: 10 minutes
4 - tcVNS 50 Hz	Experimental	Device: Pulsetto FIT™ - tcVNS 50 HzIntervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (50 Hz) Description: Bilateral cervical stimulation at 50 Hz, 250 μs pulse width. Duration: 10 minutes
5 - tcVNS 100 Hz	Experimental	Device: Pulsetto FIT™ - tcVNS 100 HzIntervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (100 Hz) Description: Bilateral cervical stimulation at 100 Hz, 250 μs pulse width. Duration: 10 minutes

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

18-30 years
Healthy (self-reported)
No cardiovascular, neurological, metabolic or psychiatric disorders
No regular medication affecting autonomic function
Non-smoker

Key exclusion criteria (9 listed)

Pregnancy
Cardiac arrhythmia
Hypertension or hypotension
Chronic respiratory disorders
Active infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pulsetto FIT™ - Sham tcVNSThe 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	Device	1 - Sham (0 Hz)
Pulsetto FIT™ - tcVNS 10 HzBilateral 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	Device	2 - 10 Hz tcVNS
Pulsetto FIT™ - tcVNS 25 HzBilateral tcVNS using the Pulsetto FIT™ device at 25 Hz, 250 µs pulse width. Stimulation intensity set at a comfortable sensory level. Dose: 10 minutes	Device	3 - tcVNS 25 Hz
Pulsetto FIT™ - tcVNS 50 HzBilateral 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	Device	4 - tcVNS 50 Hz
Pulsetto FIT™ - tcVNS 100 HzBilateral 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	Device	5 - tcVNS 100 Hz

Primary outcome

Heart Rate Variability (HRV) Changes (ΔRMSSD, ΔHF, ΔLF/HF)
Time frame: Pre- vs Post-stimulation (5-min segments)(5-minute baseline, 5-minute stimulation, 5-minute post period)
HRV is recorded using a validated high-resolution heart rate monitor (Polar H10) during a 5-minute resting baseline (T0) and a 5-minute post-stimulation period (T2). The following time- and frequency-domain parameters are analyzed: RMSSD, HF (ms²), and LF/HF ratio. Artefact correction is performed using standard HRV processing methods. Acute autonomic response is quantified by calculating change scores (Δ = post-pre) for each stimulation frequency.

3 secondary outcomes

Blood Pressure (SBP, DBP, MAP)
Time frame: Pre- vs Post-stimulation (5-minute baseline, 5-minute stimulation, 5-minute post period)
Respiratory Rate (breaths per minute)
Time frame: Pre- vs Post-stimulation (5-minute video segments) (5-minute baseline, 5-minute stimulation, 5-minute post period)
Discomfort Level (Visual Analog Scale, 0-10)
Time frame: Pre- vs Post-stimulation (5-minute baseline, 5-minute stimulation, 5-minute post period)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
Results publication: PubMed 35134082Kranz 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.
Results publication: PubMed 33839137Alsoufi 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.
Results publication: PubMed 31417453Nordahl 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.
Results publication: PubMed 11835542Peuker ET, Filler TJ. The nerve supply of the human auricle. Clin Anat. 2002 Jan;15(1):35-7. doi: 10.1002/ca.1089.
Results publication: PubMed 17081672Grossman 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.
Results publication: PubMed 26831988Zhang 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.
Results publication: PubMed 37867315Fernandes 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.
Individual participant dataSharing planned: No. Individual participant data will not be shared because the study includes physiological recordings (HRV, blood pressure, respiratory videos) that cannot be fully anonymized. Data sharing may pose a risk of indirect identification. Only aggregated results will be reported in publications and presentations. IPD Sharing Time Frame: Not applicable. IPD Sharing Access Criteria: Not applicable.

Related trials for Vagus Nerve Stimulation

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Stroke, Ischemic
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate Variability (HRV) Changes (ΔRMSSD, ΔHF, ΔLF/HF) (time frame: Pre- vs Post-stimulation (5-min segments)(5-minute baseline, 5-minute stimulation, 5-minute post period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07274332, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.