Effects of Galvanic Vestibular Stimulation on Heart Rate Variability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in Heart Rate Variability (HRV) Indices from Baseline to Post-Course and During Acute Stimulation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Failure to meet any of the inclusion criteria
结局指标
主要结局
Change in Heart Rate Variability (HRV) Indices from Baseline to Post-Course and During Acute Stimulation
时间窗: • 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.
次要结局
- Autonomic Responses by Vestibular Perception Subgroups (High vs Low/No Dizziness)(• 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))
- Stimulation-Related Sensations and Tolerability(• Days 2-5 (immediately after each stimulation session))
- Changes in Psycho-Emotional Well-Being (Depressive Symptoms, Anxiety, and Affect)(• Baseline (Day 1) • Day 6 (post-course assessment))
- Blinding Integrity Assessment(• Day 5 (immediately after the fourth stimulation session))
- Change in Positive and Negative Affect as Measured by the PANAS(• Days 2-5 (morning, pre-stimulation, post-stimulation, and end of workday))