The Cardiac Autonomic Control System Response to Vestibular Stimulation in Subjects With and Without BPPV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Heart Rate Variability- SDNN
研究概览
简要总结
The vestibular system in the inner year is an important system in the body which is responsible for balance. In addition, there is evidence that the vestibular system plays a role in maintaining blood pressure while changing body position, such as moving from lying down in bed to sitting. Dysfunction of the vestibular system may affect the ability to maintain blood pressure, therefore the aim of this study is to assess if a specific problem in the vestibular system (Benign Paroxysmal Positional Vertigo- BPPV) may cause changes in the interaction between the vestibular system and the cardiovascular system. We assume that patients with this medical condition (BPPV) will have different heart rate parameters in comparison with healthy patients.
详细描述
This is a case-control study, that will consist of one routine assessment by a vestibular physiotherapist in an outpatient clinic in Tel Aviv ("Clalit Health Services"). The session will last approximately 90 minutes, and will include 40-60 participants.
Two groups of patients (30-70 years old) will be assigned to this study:
- Patients with Benign Paroxysmal Positional Vertigo (BPPV).
- Healthy patients (Control Group).
Both groups will undergo routine physical assessment which is done to diagnose if the patient has BPPV or not. The physical assessment includes quick changes in body and head position.
In addition to the routine physical assessment, heart rate variability parameters will be monitored during the whole session in patients in both groups (using Polar watch RS800CX). Furthermore, all patients will be asked to test their grip strength (using a hand-held dynamometer), moving from sitting to standing 5 times in a row and to fill two questionnaires.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with BPPV- Patients diagnosed with BPPV, who meet the following criteria:
- •Main complain of spinning sensation (Vertigo) when changes are made in head position relative to gravity (such as when moving from sitting to lying down or rolling in bed, bending over etc.)
- •Positive Dix-Hallpike / Supine Roll Test, confirmed by presence of nystagmus.
- •Subjects without BPPV (Control group):
- •Subjects who do not suffer from dizziness / spinning sensation (Vertigo).
排除标准
- •Suffering from pain in the day of assessment.
- •Postural Hypotension.
- •Familial Dysautonomia.
- •Diabetic Neuropathy.
- •History of Whiplash or Traumatic Brain Injury (TBI) in the last year.
- •History of Stroke (CVA), Multiple Sclerosis (MS) or Central Positional Vertigo.
- •Coronary Heart Disease (CHD), Cardiac Heart Failure (CHF), Cardiac arrhythmias, Vertebrobasilar Insufficiency (VBI).
- •Under treatment of Beta- Blockers.
- •Anxiety Disorders.
- •Vestibular Migraine, Vestibular Neuritis, Menier's Disease, Perilymphatic Fistula, Superior Canal Dehiscence Syndrome.
- •Medical conditions with high risk of subluxation / dislocation of the Atlanto-axial joint.
- •Health professionals who are specialized to treat Vestibular disorders (such as Vestibular physiotherapists)
结局指标
主要结局
Heart Rate Variability- SDNN
时间窗: Through study completion, approximately 1 year
Standard Deviation of the Normal to Normal intervals
Heart Rate Variability- RMSSD
时间窗: Through study completion, approximately 1 year
Root Mean Square of the Successive Differences
次要结局
- Dizziness Handicap Inventory(Through study completion, approximately 1 year)
- Stait- Trait Anxiety Inventory(Through study completion, approximately 1 year)
研究者
Dr. Moshe Chaimoff
Dr. Moshe Chaimoff, Otolaryngology specialist, Principal investigator
Clalit Health Services