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Completed

NCT Number: NCT07715227

Vestibular Perception Gates Autonomic Responses to Sinusoidal Galvanic Vestibular Stimulation

Brief Summary This randomized, double-blind, sham-controlled clinical trial is designed to investigate whether repeated sinusoidal galvanic vestibular stimulation (GVS) influences cardiac autonomic regulation in healthy adults during their routine occupational activities, and to determine whether these effects depend on subjective vestibular perception (dizziness) experienced during stimulation.

The main questions it aims to answer are:

Does repeated sinusoidal GVS alter heart rate variability (HRV) in healthy adults during their normal work activities?

Do autonomic responses to GVS depend on the subjective intensity of dizziness experienced during stimulation?

Does repeated GVS affect psycho-emotional well-being, including depressive and anxiety symptoms?

Researchers will compare active GVS to sham stimulation to see if active stimulation produces measurable changes in cardiac autonomic regulation and whether these changes differ between participants reporting stronger versus minimal dizziness.

Participants will undergo baseline assessment, complete four consecutive daily sessions of active or sham GVS, and undergo post-intervention assessment. Autonomic responses will be assessed using multiple HRV indices.

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Key information

Conditions

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Farabi Kazakh National University, Almaty, Kazakhstan

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About this study

Detailed Description

Scientific Background and Rationale Occupational stress is recognized as an important contributor to impaired physical and mental health. Continuous exposure to cognitive workload, emotional demands, and psychosocial stressors may alter autonomic nervous system regulation, resulting in reduced physiological adaptability and increased cardiovascular risk. Heart rate variability (HRV) is one of the most widely accepted non-invasive indicators of autonomic regulation, reflecting the dynamic interaction between sympathetic and parasympathetic branches. Reduced HRV has consistently been associated with impaired stress resilience, diminished vagal regulation, increased cardiovascular morbidity, and adverse mental health outcomes.

Galvanic vestibular stimulation (GVS) applies weak electrical currents through electrodes positioned over the mastoid processes behind the ears. The electrical current activates vestibular afferents, influencing vestibular pathways that project not only to cortical vestibular regions but also to autonomic nuclei within the brainstem. Experimental and neuroanatomical studies have demonstrated direct vestibulo-autonomic connections involving the vestibular nuclei, nucleus tractus solitarius, dorsal motor nucleus of the vagus nerve, and other cardiovascular regulatory centers. Through these pathways, vestibular stimulation may influence autonomic cardiovascular regulation and HRV.

Several laboratory studies have reported that GVS may increase parasympathetic activity, reduce sympathetic influence, and modify cardiovascular reflexes. However, reported autonomic effects vary considerably across studies due to differences in stimulation parameters, waveforms, current intensity, recording conditions, and participant characteristics. Most previous investigations were conducted under highly controlled laboratory conditions, which maximize internal validity but limit ecological validity and clinical translation.

Recent technological advances have facilitated the development of portable GVS systems suitable for ambulatory use. These developments have created opportunities to evaluate vestibular neuromodulation under real-life conditions, where autonomic regulation is continuously challenged by natural fluctuations in cognitive workload, emotional demands, posture, movement, fatigue, and environmental stressors. Despite increasing interest in wearable neuromodulation technologies, the physiological effects of repeated GVS administered during normal occupational activities remain insufficiently investigated.

An additional unresolved question concerns the considerable inter-individual variability in subjective responses to vestibular stimulation. Some individuals experience pronounced sensations of self-motion or dizziness during GVS, whereas others report minimal or no vestibular sensations despite receiving identical stimulation parameters. This variability suggests that autonomic responses may depend not only on the physical characteristics of vestibular stimulation but also on the degree of conscious vestibular perception.

Current concepts of interoception and predictive processing propose that autonomic regulation is dynamically influenced by the brain's interpretation of incoming bodily signals rather than by peripheral sensory input alone. According to these models, physiological responses may be modulated by the subjective significance of sensory information and by prediction errors generated when incoming vestibular information conflicts with visual and proprioceptive signals. Therefore, conscious perception of vestibular stimulation may represent an important determinant of autonomic adaptation.

Detailed Methodology The study was conducted in two occupational settings: rest facilities of Kazakhtelecom JSC and the neurocognitive laboratories of the Brain Institute at Farabi University.

Following enrollment and baseline assessment, participants entered a four-day intervention period with one study visit per day. Each visit followed an identical protocol. Upon arrival, participants were fitted with a Polar H10 chest-mounted heart rate sensor for continuous ambulatory ECG recording. After sensor placement, participants completed the first PANAS assessment. ECG recording continued while participants performed their routine occupational activities. Immediately before stimulation, participants completed a second PANAS assessment. They subsequently received either active or sham GVS while seated comfortably with their eyes closed, listening to standardized meditative music. Immediately following stimulation, participants completed a third PANAS assessment together with a standardized questionnaire evaluating stimulation-related sensations (dizziness, warmth, burning, itching, each rated on a 4-point scale from 0 = "not experienced" to 3 = "strongly experienced"). Approximately one hour after stimulation, the sensor was removed and participants completed the fourth PANAS assessment. On the final intervention day, participants indicated whether they believed they had received active or sham stimulation to evaluate blinding integrity.

One to two days after the intervention course, participants underwent a post-intervention assessment identical to baseline procedures, including ambulatory ECG monitoring and psychometric evaluation.

Heart Rate Variability Assessment Continuous RR interval data were acquired using the Polar H10 sensor. Recordings were exported for offline processing using Kubios HRV Premium software. Artifact correction and interpolation procedures were applied before HRV calculation. HRV indices were calculated for consecutive six-minute epochs according to international recommendations.

Time-domain indices included mean RR intervals and SDNN. Frequency-domain analysis included normalized high-frequency power (HFnu). Low-frequency power was excluded from primary analyses because the stimulation frequency (0.1 Hz) overlapped with the conventional low-frequency HRV band, potentially confounding physiological interpretation. Nonlinear indices included SD1, SD2, the SD2/SD1 ratio, and detrended fluctuation analysis (DFA α1). The Baevsky Stress Index was calculated as an integrative geometric measure of regulatory strain.

HRV was analyzed at three temporal scales: acute (six-minute epochs before, during, and after stimulation), macro-scale (one-hour pre- and post-stimulation recordings), and course-level (baseline versus post-intervention comparisons).

Psychometric Assessment Psycho-emotional functioning was evaluated using standardized self-report questionnaires. The Positive and Negative Affect Schedule (PANAS) was administered repeatedly to assess short-term affective changes. Depressive symptoms were evaluated using the Inventory of Depressive Symptomatology - Self Report (IDS-SR). Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). Validated Russian-language versions were used for all questionnaires.

Statistical Analysis Baseline characteristics were compared using parametric or non-parametric tests depending on data distribution. Categorical variables were analyzed using Pearson's chi-square tests.

Psychometric outcomes were analyzed using repeated-measures ANOVA and ANCOVA with baseline adjustment when appropriate. Post hoc comparisons were corrected using Bonferroni adjustment.

Primary autonomic analyses were performed using linear mixed-effects models estimated by restricted maximum likelihood. Separate models were constructed for acute, macro-scale, and cumulative analyses. Mean heart rate was included as a time-varying covariate. Random intercepts were specified for individual participants, and first-order autoregressive covariance structures were applied to model temporal dependence among repeated observations. Model assumptions were evaluated using residual diagnostics. Effect sizes were calculated using partial eta squared (η²p).

Participants were prospectively stratified according to average dizziness ratings using median split classification to create High-Dizziness and Low/No-Dizziness subgroups. Sensitivity analyses evaluated dizziness as a continuous variable to confirm robustness.

Safety Monitoring Participant safety was monitored throughout the intervention. Immediately after each session, participants completed questionnaires documenting stimulation-related sensations. No medications were administered, and no invasive procedures were performed. Participants were free to discontinue their participation at any time without providing a reason. No penalties or consequences were applied for withdrawal, and participants retained the right to withdraw their data upon request.

Scientific Significance This study was designed to extend previous laboratory investigations by evaluating autonomic and psycho-emotional responses to GVS under ecologically valid occupational conditions. By integrating acute, short-term recovery, and cumulative assessments during participants' normal professional activities, the study addresses a gap in the current literature regarding real-world applicability of vestibular neuromodulation. The prospective evaluation of subjective vestibular perception as a potential moderator of autonomic responses represents a conceptual innovation. The findings are expected to contribute to individualized non-invasive neuromodulation approaches and provide additional evidence regarding the physiological safety and tolerability of repeated sinusoidal GVS in healthy adults.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Аge between 18 and 49 years
  • Absence of dermatological conditions (e.g., eczema, psoriasis) or open wounds in the electrode placement area (mastoid region)
  • No metallic or electronic implants (e.g., pacemakers, cochlear implants)
  • No history of neurological, psychiatric, or cardiovascular disorders
  • Not currently pregnant
  • Employment or activities not involving the operation of vehicles or hazardous machinery

Exclusion criteria

  • Failure to meet any of the inclusion criteria

Treatment and study plan

Galvanic Vestibular Stimulation (GVS) using BrainPatch device

Device

Sinusoidal galvanic vestibular stimulation delivered via bilateral mastoid electrodes using the portable BrainPatch device. Stimulation parameters: 0.1 Hz sinusoidal waveform, peak current 0.62 mA, administered for 6 minutes per session with participants seated, eyes closed, and listening to relaxing meditative music.

Other names: GVS

Primary outcomes

  1. Change in Heart Rate Variability (HRV) Indices from Baseline to Post-Course and During Acute Stimulation

    Time frame: • Baseline (Day 1) • Days 2-5 (pre-stimulation, during 6-minute stimulation, immediately post-stimulation, and 1 hour post-stimulation) • Day 6 (post-course assessment)

    HRV will be assessed using complementary indices derived from continuous ambulatory ECG recordings (Polar H10) across multiple temporal scales: (1) course-level: baseline vs. post-course comparison; (2) acute: pre-stimulation, during stimulation, and post-stimulation epochs; (3) macro-scale: one-hour pre-stimulation vs. one-hour post-stimulation windows. Indices include time-domain (SDNN, mean RR intervals), frequency-domain (HFnu), nonlinear (SD1, SD2, SD2/SD1 ratio, DFA α1), and geometric (Baevsky Stress Index) measures.

Secondary outcomes

  1. Autonomic Responses by Vestibular Perception Subgroups (High vs Low/No Dizziness)

    Time frame: • Baseline (Day 1) • Days 2-5 (pre-stimulation, during 6-minute stimulation, immediately post-stimulation, and 1 hour post-stimulation) • Day 6 (post-course assessment)

    Comparison of HRV changes between participants stratified by dizziness intensity (High Dizziness vs Low/No Dizziness) using median split based on average dizziness ratings across intervention days. Outcomes include RR, HFnu, SD1, SD2/SD1 ratio, DFA α1, and Stress Index.

  2. Stimulation-Related Sensations and Tolerability

    Time frame: • Days 2-5 (immediately after each stimulation session)

    Participants rated the intensity of dizziness, warmth, burning, itching, pain, metallic taste, nausea, discomfort, and fatigue using a 4-point ordinal scale (0 = "not experienced" to 3 = "strongly experienced") immediately after each session. Average dizziness ratings across the four sessions were used to stratify participants into High Dizziness and Low/No Dizziness subgroups for secondary analyses of autonomic responses.

  3. Changes in Psycho-Emotional Well-Being (Depressive Symptoms, Anxiety, and Affect)

    Time frame: • Baseline (Day 1) • Day 6 (post-course assessment)

    Assessment of depressive symptom severity using the Inventory of Depressive Symptomatology - Self Report (IDS-SR), anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7), and positive and negative affect using the Positive and Negative Affect Schedule (PANAS). The IDS-SR and GAD-7 were administered once at baseline (Day 1) and once at post-course assessment (Day 6). The PANAS was administered at Day 1 (upon arrival and at sensor removal) and Day 6 (upon arrival and at sensor removal).

  4. Blinding Integrity Assessment

    Time frame: • Day 5 (immediately after the fourth stimulation session)

    Participants were asked to indicate whether they believed they had received active GVS or sham stimulation. The distribution of guesses was compared between the Active GVS and Sham groups using Pearson's chi-square test to evaluate the effectiveness of blinding.

  5. Change in Positive and Negative Affect as Measured by the PANAS

    Time frame: • Days 2-5 (morning, pre-stimulation, post-stimulation, and end of workday)

    The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report questionnaire consisting of two 10-item subscales measuring positive affect (PA) and negative affect (NA). Participants rate the extent to which they have experienced each emotion over the past week on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). Scores for each subscale range from 10 to 50, with higher scores indicating greater positive or negative affect. The PANAS was administered four times daily during each of the four intervention days (morning, pre-stimulation, post-stimulation, and end of workday).

Sponsors and collaborators

Lead sponsor

Al-Farabi Kazakh National University

Other

Collaborators

  • BrainPatch
  • Research and Production Center "Comprehensive Equipment"

Registry information

Official study title

Effects of Galvanic Vestibular Stimulation on Heart Rate Variability

Acronym: GVS-HRV

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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