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临床试验/NCT07472998
NCT07472998招募中不适用

Evaluation of Autonomic Function Using Short-Term Heart Rate Variability in Patients With Benign Paroxysmal Positional Vertigo: A Prospective Case-Control Study

Istanbul Aydın University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
104
试验地点
1
主要终点
Root Mean Square of Successive Differences (RMSSD)

研究概览

简要总结

Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder. Although the pathophysiology of BPPV is mainly attributed to the displacement of otoconia within the semicircular canals, recent studies suggest that psychological stress and anxiety may be associated with the onset or recurrence of the disease. However, the biological mechanisms underlying this relationship remain poorly understood, and objective evaluation of autonomic nervous system function in patients with BPPV is limited.

Heart rate variability (HRV) is a non-invasive method widely used to assess autonomic nervous system activity. Short-term HRV measurements provide information about autonomic balance and vagal tone. In particular, parameters such as the root mean square of successive differences (RMSSD) and the coefficient of variation of RR intervals (COV RR/R) are considered indicators of parasympathetic activity.

The aim of this prospective case-control study is to evaluate vagal tone in patients with BPPV using short-term HRV analysis and to compare the findings with age-, sex-, and body mass index-matched healthy controls. Participants will undergo standardized HRV measurements at rest and during controlled breathing. Perceived stress levels will also be assessed using the Perceived Stress Scale (PSS-10).

The primary outcomes of the study are RMSSD and the coefficient of variation of RR intervals (COV RR/R), obtained from short-term HRV recordings. These parameters will be compared between BPPV patients and healthy controls, and their associations with perceived stress levels will also be explored. The findings of this study may provide insights into the role of autonomic regulation and stress-related mechanisms in the pathophysiology of BPPV.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BPPV Group
  • Age 18 years or older
  • Clinical diagnosis of benign paroxysmal positional vertigo (BPPV) confirmed by positional testing (Dix-Hallpike and/or Roll test) with positional nystagmus
  • No known history of cardiac disease
  • Ability and willingness to provide written informed consent
  • Healthy Control Group
  • Age 18 years or older
  • No history of vertigo or known vestibular disorder
  • Age- and sex-matched to the BPPV group
  • No known history of cardiac disease
  • Ability and willingness to provide written informed consent

排除标准

  • Age younger than 18 years
  • Inability to provide informed consent or impaired mental capacity
  • Known arrhythmia, heart failure, ischemic heart disease, or other clinically significant cardiac disorder
  • Use of medications that may directly affect heart rate variability, including beta-blockers, non-dihydropyridine calcium channel blockers, antiarrhythmic drugs, digoxin, systemic corticosteroids, centrally acting sympatholytic agents, or psychotropic medications that may influence autonomic balance
  • Active infection or systemic inflammatory disease

研究组 & 干预措施

BPPV Group

Patients diagnosed with benign paroxysmal positional vertigo (BPPV) based on positional testing in the otolaryngology clinic.

干预措施: Short-term HRV measurement (Other)

Healthy Control Group

Age-, sex-, and body mass index-matched healthy volunteers without a history of vestibular disorders

干预措施: Short-term HRV measurement (Other)

结局指标

主要结局

Root Mean Square of Successive Differences (RMSSD)

时间窗: Baseline (At the time of HRV assessment (single visit))

Root Mean Square of Successive Differences (RMSSD), expressed in milliseconds (ms), obtained from short-term heart rate variability recordings using the UltraPro S100 EMG/NCS/EP Neurodiagnostic System. RR interval variability will be recorded through hand electrodes during two conditions: resting state and controlled breathing (6 breaths per minute for 60 seconds). RMSSD values will be compared between patients with benign paroxysmal positional vertigo (BPPV) and healthy control participants.

Coefficient of Variation of RR Intervals (COV RR)

时间窗: Baseline (At the time of HRV assessment (single visit))

Coefficient of variation of RR intervals (COV RR), expressed as percentage (%), derived from short-term heart rate variability recordings using the UltraPro S100 EMG/NCS/EP Neurodiagnostic System. RR interval variability will be recorded through hand electrodes during resting conditions and controlled breathing (6 breaths per minute for 60 seconds). COV RR values will be compared between patients with benign paroxysmal positional vertigo (BPPV) and healthy controls.

次要结局

  • Change in RMSSD During Controlled Breathing (ΔRMSSD)(Baseline (single HRV assessment visit))
  • Change in COV RR During Controlled Breathing (ΔCOV RR)(Baseline (single HRV assessment visit))

研究者

发起方
Istanbul Aydın University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dastan Temirbekov

Assistan Professor

Istanbul Aydın University

研究点 (1)

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