Autonomic Nervous System (ANS) Functioning and Mood StatetaVNS-HRVNCT07548723
taVNS During Multi-site HRV Measurement: Reliability & Agreement Study
A study testing Transcutaneous auricular vagus nerve stimulation in people with Autonomic Nervous System (ANS) Functioning and Mood State and Heart Rate Variability (HRV), run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).
Trial summary
This study examines the reliability and agreement of autonomic nervous system measurements obtained from different anatomical sites during transcutaneous auricular vagus nerve stimulation (taVNS). taVNS is a non-invasive electrical stimulation delivered to the ear using a small stimulator. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System (ANS) Functioning and Mood State, Heart Rate Variability (HRV), Blood Pressure Monitoring
- What is being tested?
- Transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2023to 5 May 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 40 years.
- Healthy volunteers without known chronic disease or acute illness at the time of participation.
- Able and willing to comply with study procedures and instructions.
- Provided written informed consent.
Who cannot join
- Any cardiovascular disease, arrhythmia, hypertension, or similar condition. Any neurological disorder (e.g., diabetes mellitus, peripheral neuropathy, epilepsy).
- Any diagnosed psychiatric disorder.
- Pregnancy or suspected pregnancy.
- Ear conditions that prevent stimulation (infection, open wound, pain/tenderness) or the presence of a piercing at/near the stimulation site.
- Vigorous exercise within 24 hours prior to the measurement.
- Caffeine intake, smoking, or alcohol consumption within 4-6 hours prior to the measurement.
- Marked intolerance or hypersensitivity to the devices or the procedure.
- Inability to follow instructions during measurements or refusal to complete the session.
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
Güzelyurt Neighborhood, Mustafa Bozkurt Street, No: 9, Türkeli, Sinop, Türkiye
Sinop, 57900
About this study
Official title: Assessment of Reliability and Agreement of Autonomic Measures Across Different Anatomical Sites During Transcutaneous Auricular Vagus Nerve Stimulation
This study examines the reliability and agreement of autonomic nervous system measurements obtained from different anatomical sites during transcutaneous auricular vagus nerve stimulation (taVNS). taVNS is a non-invasive electrical stimulation delivered to the ear using a small stimulator. Healthy volunteers aged 18-40 years will participate in one laboratory session. Heart rate and heart rate variability will be recorded from the chest (reference), finger, and arm. Blood pressure and pulse will also be measured. Data will be collected in three standardized periods: T0 (5-minute resting baseline), T1 (10 minutes during taVNS), and T2 (5-minute recovery). The main goal is to determine how closely finger- and arm-based measurements match the chest reference and how consistent these measurements are across the study periods. Participation is voluntary, and participants may withdraw at any time. Expected risks are minimal and may include temporary tingling or mild discomfort at the ear and, rarely, lightheadedness. No direct medical benefit is expected, but the findings may help improve how autonomic responses are monitored during taVNS in future research.
Read the detailed description
Heart rate variability (HRV) is widely used to quantify autonomic regulation, and non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) may acutely influence cardiac autonomic activity. In both clinical and research settings, autonomic measures can be recorded from different sites using different sensor technologies. However, it is not always clear whether HRV-related indices derived from peripheral recordings (e.g., finger or arm photoplethysmography-based signals) provide comparable results to chest-based reference recordings. This study is designed as a methodological reliability and agreement investigation to determine the consistency of autonomic measures across anatomical sites during a standardized taVNS session.
Participants will attend a single laboratory visit with standardized pre-test instructions (e.g., avoidance of heavy exercise and stimulants before measurement, as applicable). Autonomic measures will be recorded from multiple sites in parallel, using the chest recording as the reference for beat-to-beat intervals. Finger and arm recordings will be obtained simultaneously to allow direct, time-aligned comparisons across sites within the same physiological state. Blood pressure and pulse will be measured during the session to provide complementary hemodynamic context.
The session consists of consecutive measurement periods representing baseline, stimulation, and recovery. Data will be processed using standard HRV pipelines (including artifact inspection and correction when needed) to derive time-domain and frequency-domain indices. The primary analyses will focus on (1) inter-site agreement (bias and limits of agreement) and (2) reliability/consistency metrics across the measurement periods. Agreement will be evaluated using Bland-Altman approaches and related indices, while reliability will be quantified using intraclass correlation coefficients (ICCs) with appropriate model specification. Secondary analyses may explore the association between HRV indices and hemodynamic parameters across periods.
This study involves minimal risk. Expected adverse effects, if any, are transient (e.g., mild ear discomfort or tingling, and rarely lightheadedness). Participant safety will be monitored by the study team throughout the session, and the procedure will be stopped if a participant requests discontinuation or if concerning symptoms occur. Data will be recorded and stored in a de-identified format, and results will be reported at the group level.
- Conditions
- Autonomic Nervous System (ANS) Functioning and Mood State, Heart Rate Variability (HRV), Blood Pressure Monitoring, Transcutaneous Electric Nerve Stimulation, Photoplethysmography
- Being tested
- Transcutaneous auricular vagus nerve stimulation
- Keywords
- Transcutaneous auricular vagus nerve stimulation, Autonomic nervous system, Anatomical measurement sites, Heart rate variability, Measurement reliability, Method comparison, Agreement analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous auricular vagus nerve stimulationDevice
Transcutaneous auricular vagus nerve stimulation will be delivered to the cymba conchae region of the auricle using an external stimulator. Stimulation will be set to 25 Hz with a pulse width of 200-300 microseconds. Current intensity will be individually adjusted to a clearly perceptible but non-painful level (typically 0.5-5 mA). Stimulation will be applied for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation - Single Session | Experimental | All participants receive a single session of transcutaneous auricular vagus nerve stimulation (taVNS). Autonomic measures are recorded simultaneously from chest (reference), finger, and arm during baseline (T0, 5 min), stimulation (T1, 10 min), and recovery (T2, 5 min). Blood pressure and pulse are also measured during the session. No separate arms or randomization are used. Receives: Device: Transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
RMSSD inter-site agreement across chest, finger, and arm recordings
Root mean square of successive differences (RMSSD) derived from simultaneous recordings at three sites (chest as reference, finger, and arm) will be compared to determine inter-site agreement and reliability. Agreement will be evaluated using Bland-Altman analysis (bias and limits of agreement), and reliability/consistency will be quantified using intraclass correlation coefficients (ICC). Unit of Measure: ms
Measured: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).
SDNN inter-site agreement across chest, finger, and arm recordings
Standard deviation of normal-to-normal intervals (SDNN) derived from simultaneous recordings at three sites (chest as reference, finger, and arm) will be compared to determine inter-site agreement and reliability. Agreement will be evaluated using Bland-Altman analysis (bias and limits of agreement), and reliability/consistency will be quantified using intraclass correlation coefficients (ICC). Unit of Measure: ms
Measured: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).
LF power inter-site agreement across chest, finger, and arm recordings
Low-frequency (LF) power derived from simultaneous recordings at three sites (chest as reference, finger, and arm) will be compared to determine inter-site agreement and reliability. Agreement will be evaluated using Bland-Altman analysis (bias and limits of agreement), and reliability/consistency will be quantified using intraclass correlation coefficients (ICC). Unit of Measure: ms²
Measured: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).
HF power inter-site agreement across chest, finger, and arm recordings
High-frequency (HF) power derived from simultaneous recordings at three sites (chest as reference, finger, and arm) will be compared to determine inter-site agreement and reliability. Agreement will be evaluated using Bland-Altman analysis (bias and limits of agreement), and reliability/consistency will be quantified using intraclass correlation coefficients (ICC). Unit of Measure: ms²
Measured: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).
LF/HF ratio inter-site agreement across chest, finger, and arm recordings
The low-frequency to high-frequency ratio (LF/HF ratio) derived from simultaneous recordings at three sites (chest as reference, finger, and arm) will be compared to determine inter-site agreement and reliability. Agreement will be evaluated using Bland-Altman analysis (bias and limits of agreement), and reliability/consistency will be quantified using intraclass correlation coefficients (ICC). Unit of Measure: unitless
Measured: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).
Secondary outcomes (3)
Systolic blood pressure
Systolic blood pressure will be measured to characterize hemodynamic responses during the single-session protocol, including baseline, stimulation, and recovery periods. Unit of Measure: mmHg.
Measured: Single session: baseline (5 minutes), stimulation (10 minutes), and recovery (5 minutes)
Diastolic blood pressure
Diastolic blood pressure will be measured to characterize hemodynamic responses during the single-session protocol, including baseline, stimulation, and recovery periods. Unit of Measure: mmHg.
Measured: Single session: baseline (5 minutes), stimulation (10 minutes), and recovery (5 minutes).
Heart rate during transcutaneous auricular vagus nerve stimulation
Heart rate will be recorded to characterize cardiovascular responses during the single-session protocol, including baseline, stimulation, and recovery periods. Unit of Measure: beats per minute (bpm).
Measured: Single session: baseline (5 minutes), stimulation (10 minutes), and recovery (5 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start20 Mar 2023
- Primary completion20 Apr 2026 (estimated)
- Study completion5 May 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 Autonomic Nervous System (ANS) Functioning and Mood StateStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, within-subject design. All participants complete one standardized session consisting of baseline (T0), stimulation (T1), and recovery (T2). Autonomic measures are recorded simultaneously from multiple anatomical sites (chest as reference, finger, and arm) to assess inter-site reliability and agreement; no separate study arms or randomization are used.
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SEFA HAKTAN HATIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SEFA HAKTAN HATIK, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548723
- Sponsor's protocol ID
- taVNS1
- Other IDs
- BEU-ETH 2026/01-11
- Acronym
- taVNS-HRV
- Status last verified
- Apr 2026
- First submitted
- 22 Feb 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared at this time. Only aggregated, de-identified results will be reported in publications. The dataset includes sensitive physiological measurements, and access will be limited to the research team to protect participant privacy. IPD sharing may be reconsidered in the future upon reasonable request and with appropriate ethical and institutional approvals.
Publications
Coste A, Millour G, Hausswirth C. A Comparative Study Between ECG- and PPG-Based Heart Rate Sensors for Heart Rate Variability Measurements: Influence of Body Position, Duration, Sex, and Age. Sensors (Basel). 2025 Sep 15;25(18):5745. doi: 10.3390/s25185745.
PubMed 41012985Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
PubMed 8598068Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
PubMed 27330520Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420.
PubMed 18839484Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
PubMed 2868172Wang Y, Li SY, Wang D, Wu MZ, He JK, Zhang JL, Zhao B, Hou LW, Wang JY, Wang L, Wang YF, Zhang Y, Zhang ZX, Rong PJ. Transcutaneous Auricular Vagus Nerve Stimulation: From Concept to Application. Neurosci Bull. 2021 Jun;37(6):853-862. doi: 10.1007/s12264-020-00619-y. Epub 2020 Dec 23.
PubMed 33355897Hatik SH, Bagci U, Arslan M, Pehlivanoglu BE. Reliability and inter-device agreement of multi-site heart rate variability measurements during transcutaneous auricular vagus nerve stimulation: a prospective single-arm methodological physiological study. BMC Cardiovasc Disord. 2026 Sep 2;26(1):900. doi: 10.1186/s12872-026-06556-4.
PubMed 42859155
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Reliability and Agreement of Autonomic Measures Across Different Anatomical Sites During Transcutaneous Auricular Vagus Nerve Stimulation
- ClinicalTrials.gov ID
- NCT07548723
- Acronym / sponsor ID
- taVNS-HRV / taVNS1
- Conditions
- Autonomic Nervous System (ANS) Functioning and Mood State, Heart Rate Variability (HRV), Blood Pressure Monitoring, Transcutaneous Electric Nerve Stimulation, Photoplethysmography
- Keywords
- Transcutaneous auricular vagus nerve stimulation, Autonomic nervous system, Anatomical measurement sites, Heart rate variability, Measurement reliability, Method comparison, Agreement analysis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- SEFA HAKTAN HATIKUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 5 May 2026 (estimated)
- First posted
- 23 Apr 2026 (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.
This study examines the reliability and agreement of autonomic nervous system measurements obtained from different anatomical sites during transcutaneous auricular vagus nerve stimulation (taVNS). taVNS is a non-invasive electrical stimulation delivered to the ear using a small stimulator. Healthy volunteers aged 18-40 years will participate in one laboratory session. Heart rate and heart rate variability will be recorded from the chest (reference), finger, and arm. Blood pressure and pulse will also be measured. Data will be collected in three standardized periods: T0 (5-minute resting baseline), T1 (10 minutes during taVNS), and T2 (5-minute recovery). The main goal is to determine how closely finger- and arm-based measurements match the chest reference and how consistent these measurements are across the study periods. Participation is voluntary, and participants may withdraw at any time. Expected risks are minimal and may include temporary tingling or mild discomfort at the ear and, rarely, lightheadedness. No direct medical benefit is expected, but the findings may help improve how autonomic responses are monitored during taVNS in future research.
Detailed description
Heart rate variability (HRV) is widely used to quantify autonomic regulation, and non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) may acutely influence cardiac autonomic activity. In both clinical and research settings, autonomic measures can be recorded from different sites using different sensor technologies. However, it is not always clear whether HRV-related indices derived from peripheral recordings (e.g., finger or arm photoplethysmography-based signals) provide comparable results to chest-based reference recordings. This study is designed as a methodological reliability and agreement investigation to determine the consistency of autonomic measures across anatomical sites during a standardized taVNS session.
Participants will attend a single laboratory visit with standardized pre-test instructions (e.g., avoidance of heavy exercise and stimulants before measurement, as applicable). Autonomic measures will be recorded from multiple sites in parallel, using the chest recording as the reference for beat-to-beat intervals. Finger and arm recordings will be obtained simultaneously to allow direct, time-aligned comparisons across sites within the same physiological state. Blood pressure and pulse will be measured during the session to provide complementary hemodynamic context.
The session consists of consecutive measurement periods representing baseline, stimulation, and recovery. Data will be processed using standard HRV pipelines (including artifact inspection and correction when needed) to derive time-domain and frequency-domain indices. The primary analyses will focus on (1) inter-site agreement (bias and limits of agreement) and (2) reliability/consistency metrics across the measurement periods. Agreement will be evaluated using Bland-Altman approaches and related indices, while reliability will be quantified using intraclass correlation coefficients (ICCs) with appropriate model specification. Secondary analyses may explore the association between HRV indices and hemodynamic parameters across periods.
This study involves minimal risk. Expected adverse effects, if any, are transient (e.g., mild ear discomfort or tingling, and rarely lightheadedness). Participant safety will be monitored by the study team throughout the session, and the procedure will be stopped if a participant requests discontinuation or if concerning symptoms occur. Data will be recorded and stored in a de-identified format, and results will be reported at the group level.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, within-subject design. All participants complete one standardized session consisting of baseline (T0), stimulation (T1), and recovery (T2). Autonomic measures are recorded simultaneously from multiple anatomical sites (chest as reference, finger, and arm) to assess inter-site reliability and agreement; no separate study arms or randomization are used.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation - Single Session | Experimental | Device: Transcutaneous auricular vagus nerve stimulationAll participants receive a single session of transcutaneous auricular vagus nerve stimulation (taVNS). Autonomic measures are recorded simultaneously from chest (reference), finger, and arm during baseline (T0, 5 min), stimulation (T1, 10 min), and recovery (T2, 5 min). Blood pressure and pulse are also measured during the session. No separate arms or randomization are used. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 40 years.
- Healthy volunteers without known chronic disease or acute illness at the time of participation.
- Able and willing to comply with study procedures and instructions.
- Provided written informed consent.
Key exclusion criteria (8 listed)
- Any cardiovascular disease, arrhythmia, hypertension, or similar condition. Any neurological disorder (e.g., diabetes mellitus, peripheral neuropathy, epilepsy).
- Any diagnosed psychiatric disorder.
- Pregnancy or suspected pregnancy.
- Ear conditions that prevent stimulation (infection, open wound, pain/tenderness) or the presence of a piercing at/near the stimulation site.
- Vigorous exercise within 24 hours prior to the measurement.
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 |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulationTranscutaneous auricular vagus nerve stimulation will be delivered to the cymba conchae region of the auricle using an external stimulator. Stimulation will be set to 25 Hz with a pulse width of 200-300 microseconds. Current intensity will be individually adjusted to a clearly perceptible but non-painful level (typically 0.5-5 mA). Stimulation will be applied for 10 minutes. | Device | Transcutaneous Auricular Vagus Nerve Stimulation - Single Session |
Primary outcome
RMSSD inter-site agreement across chest, finger, and arm recordings
Time frame: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).
Root mean square of successive differences (RMSSD) derived from simultaneous recordings at three sites (chest as reference, finger, and arm) will be compared to determine inter-site agreement and reliability. Agreement will be evaluated using Bland-Altman analysis (bias and limits of agreement), and reliability/consistency will be quantified using intraclass correlation coefficients (ICC). Unit of Measure: ms
SDNN inter-site agreement across chest, finger, and arm recordings
Time frame: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).
Standard deviation of normal-to-normal intervals (SDNN) derived from simultaneous recordings at three sites (chest as reference, finger, and arm) will be compared to determine inter-site agreement and reliability. Agreement will be evaluated using Bland-Altman analysis (bias and limits of agreement), and reliability/consistency will be quantified using intraclass correlation coefficients (ICC). Unit of Measure: ms
LF power inter-site agreement across chest, finger, and arm recordings
Time frame: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).
Low-frequency (LF) power derived from simultaneous recordings at three sites (chest as reference, finger, and arm) will be compared to determine inter-site agreement and reliability. Agreement will be evaluated using Bland-Altman analysis (bias and limits of agreement), and reliability/consistency will be quantified using intraclass correlation coefficients (ICC). Unit of Measure: ms²
HF power inter-site agreement across chest, finger, and arm recordings
Time frame: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).
High-frequency (HF) power derived from simultaneous recordings at three sites (chest as reference, finger, and arm) will be compared to determine inter-site agreement and reliability. Agreement will be evaluated using Bland-Altman analysis (bias and limits of agreement), and reliability/consistency will be quantified using intraclass correlation coefficients (ICC). Unit of Measure: ms²
LF/HF ratio inter-site agreement across chest, finger, and arm recordings
Time frame: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).
The low-frequency to high-frequency ratio (LF/HF ratio) derived from simultaneous recordings at three sites (chest as reference, finger, and arm) will be compared to determine inter-site agreement and reliability. Agreement will be evaluated using Bland-Altman analysis (bias and limits of agreement), and reliability/consistency will be quantified using intraclass correlation coefficients (ICC). Unit of Measure: unitless
3 secondary outcomes
Systolic blood pressure
Time frame: Single session: baseline (5 minutes), stimulation (10 minutes), and recovery (5 minutes)
Diastolic blood pressure
Time frame: Single session: baseline (5 minutes), stimulation (10 minutes), and recovery (5 minutes).
Heart rate during transcutaneous auricular vagus nerve stimulation
Time frame: Single session: baseline (5 minutes), stimulation (10 minutes), and recovery (5 minutes).
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 23 Apr 2026.
- Background: PubMed 41012985Coste A, Millour G, Hausswirth C. A Comparative Study Between ECG- and PPG-Based Heart Rate Sensors for Heart Rate Variability Measurements: Influence of Body Position, Duration, Sex, and Age. Sensors (Basel). 2025 Sep 15;25(18):5745. doi: 10.3390/s25185745.
- Background: PubMed 8598068Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
- Background: PubMed 27330520Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
- Background: PubMed 18839484Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420.
- Background: PubMed 2868172Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- Background: PubMed 33355897Wang Y, Li SY, Wang D, Wu MZ, He JK, Zhang JL, Zhao B, Hou LW, Wang JY, Wang L, Wang YF, Zhang Y, Zhang ZX, Rong PJ. Transcutaneous Auricular Vagus Nerve Stimulation: From Concept to Application. Neurosci Bull. 2021 Jun;37(6):853-862. doi: 10.1007/s12264-020-00619-y. Epub 2020 Dec 23.
- Derived from this study: PubMed 42859155Hatik SH, Bagci U, Arslan M, Pehlivanoglu BE. Reliability and inter-device agreement of multi-site heart rate variability measurements during transcutaneous auricular vagus nerve stimulation: a prospective single-arm methodological physiological study. BMC Cardiovasc Disord. 2026 Sep 2;26(1):900. doi: 10.1186/s12872-026-06556-4.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared at this time. Only aggregated, de-identified results will be reported in publications. The dataset includes sensitive physiological measurements, and access will be limited to the research team to protect participant privacy. IPD sharing may be reconsidered in the future upon reasonable request and with appropriate ethical and institutional approvals.
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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?
A study testing Transcutaneous auricular vagus nerve stimulation in people with Autonomic Nervous System (ANS) Functioning and Mood State and Heart Rate Variability (HRV), run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 23 Apr 2026. 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. 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?
RMSSD inter-site agreement across chest, finger, and arm recordings (time frame: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).). The study lists 5 primary outcomes in all. 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 NCT07548723, 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 23 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.