Evidence map›Paper›PMID 42859155›Full record

Trial reportBMC cardiovascular disorders2026

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.

Sefa Haktan Hatik, Uğur Bağci, Mesut Arslan, Berkay Eren Pehlivanoğlu

Registry-linked trialAbstract readClinical TrialComparative Study
In one paragraph

Trial report in BMC cardiovascular disorders, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07548723 (Assessment of Reliability and Agreement of Autonomic Measures Across Different Anatomical Sites During Transcutaneous Auricular Vagus Nerve Stimulation), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07548723 naenrolling by invitationnot on this map

Assessment of Reliability and Agreement of Autonomic Measures Across Different Anatomical Sites During Transcutaneous Auricular Vagus Nerve Stimulation

TypeinterventionalSponsorSEFA HAKTAN HATIKRan2023 to 2026Enrolled1ConditionsAutonomic Nervous System (ANS) Functioning and Mood State, Heart Rate Variability (HRV), Blood Pressure Monitoring, Transcutaneous Electric Nerve StimulationArmsTranscutaneous auricular vagus nerve stimulation
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Sefa Haktan HatikDepartment of Health Care Services, Türkeli Vocational School, Sinop University, Güzelyurt Neighborhood, Mustafa Bozkurt Street, No: 9, Türkeli, Sinop, 57900, Türkiye. haktanhtk@gmail.com.ORCID http://orcid.org/0000-0003-0517-4600
Uğur BağciDepartment of Health Care Services, Yusufeli Vocational School, Artvin Çoruh University, Artvin, Türkiye.ORCID http://orcid.org/0009-0001-1835-0493
Mesut ArslanDepartment of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Bitlis Eren University, Bitlis, Türkiye.ORCID http://orcid.org/0000-0002-4779-2442
Berkay Eren PehlivanoğluDepartment of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Bahçeşehir University, İstanbul, Türkiye.ORCID http://orcid.org/0000-0002-1182-6161

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranscutaneous auricular vagus nerve stimulation (taVNS) has been associated with acute changes in cardiac autonomic measures; however, agreement between electrocardiography-derived heart rate variability (HRV) and photoplethysmography-derived pulse rate variability (PRV) obtained from different anatomical sites across a taVNS protocol remains unclear. This study evaluated the reliability, inter-device agreement, and pre-post measurement patterns of chest-, fingertip-, and upper-arm-derived HRV/PRV measurements.

methodsThis prospective, single-center, single-arm methodological physiological study included 40 healthy volunteers. Electrocardiography-based chest measurements were obtained with Polar H10 as the reference device, while photoplethysmography-based measurements were obtained simultaneously from the fingertip using CorSense and from the upper arm using Polar Verity Sense. Bilateral taVNS was applied to the cymba conchae for 10 min. Five-minute recordings were performed before and immediately after stimulation. Heart rate (HR), RR interval, RMSSD, SDNN, low frequency (LF), high frequency (HF), and LF/HF were analyzed. Inter-device agreement was assessed using ICC(A,1), Bland-Altman analysis, and Lin's concordance correlation coefficient. Time, device, and time-by-device effects were examined using linear mixed models.

resultsIn the Polar H10 reference measurements, HR was significantly lower at post-stimulation (Hodges-Lehmann estimate = - 1.50 beats/min, 95% CI - 3.00 to - 0.50; p = 0.019), whereas RR interval (Hodges-Lehmann estimate = 15.11 ms, 95% CI 1.35 to 31.36; p = 0.033), RMSSD (Hodges-Lehmann estimate = 2.67 ms, 95% CI 0.12 to 6.62; p = 0.045), and SDNN (mean difference = 6.33 ms, 95% CI 2.00 to 10.65; p = 0.005) were significantly higher. Agreement was excellent for HR (ICC range 0.980-0.996) and RR interval (ICC range 0.952-0.998), whereas RMSSD and SDNN agreement varied by sensor pair. For RMSSD, H10-Verity Sense showed stronger agreement than H10-CorSense (ICC range 0.863-0.882 vs. 0.354-0.490; CCC range 0.861-0.881 vs. 0.351-0.486). Frequency-domain agreement was less consistent, and no time-by-device interaction was significant for any HRV parameter. Systolic blood pressure was significantly lower at post-stimulation (mean difference = - 7.0 mmHg, 95% CI - 9.7 to - 4.2; p < 0.001), and ΔRMSSD was moderately inversely correlated with Δsystolic blood pressure (Spearman ρ = -0.418; p = 0.007).

conclusionsPre-post autonomic changes were broadly consistent across chest, fingertip, and upper-arm measurements, although inter-device agreement varied by HRV/PRV parameter. HR and RR interval showed excellent agreement, whereas RMSSD, SDNN, and frequency-domain indices were less consistent. Given the single-arm design, these findings should be interpreted as physiological measurement changes rather than causal effects of taVNS.

trial registrationClinicalTrials.gov: NCT07548723. Registered 22 February 2026.

Indexed as

Autonomic Nervous SystemElectrocardiographyHeart RatePhotoplethysmographyTranscutaneous Electric Nerve StimulationVagus NerveVagus Nerve StimulationAdultFemaleHealthy VolunteersHumansMaleMiddle AgedObserver VariationPredictive Value of TestsProspective StudiesBland-Altman analysisHeart rate variabilityInter-device agreementPhotoplethysmographyPulse rate variabilityTranscutaneous auricular vagus nerve stimulationWearable sensors

Identifiers

PMID42859155
PMCPMC13654223

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.