The Cardiac Autonomic Control System Response to Vestibular Stimulation in Subjects With and Without BPPV

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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. The patients that were diagnosed with BPPV will be treated with the routine vestibular physiotherapy, performed by the same physiotherapist who did the physical assessment. Statistical analysis of the data will be performed in IBM SPSS Statistics software (version 24), and a statistical significance level of a p-value < 0.05 will be considered significant. Normality distribution will be tested with the Kolmagorov-Smirnov test. Parametric tests suitable for the analysis of the data in this study are: Paired and unpaired t-tests. Repeated Measures Analysis of Variance (ANOVA). Non-parametric tests suitable for the analysis of the data in this study are: Mann-Whitney. Wilcoxon. Spearman coefficient will be used to examine correlations.

Official Title
-----------------
The Cardiac Autonomic Control System Response to Vestibular Stimulation in Subjects With and Without BPPV

Conditions
-----------------
Benign Paroxysmal Positional Vertigo, Vertigo, Autonomic Nervous System

Intervention / Treatment
-----------------
* Diagnostic Test: Heart rate variability parameters monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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). Exclusion Criteria: 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)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with BPPV<br>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. Positive Dix-Hallpike / Supine Roll Test, confirmed by presence of nystagmus. | Diagnostic Test: Heart rate variability parameters monitoring<br>* No intervention- only additional monitoring of heart rate, physical tests and filling of questionnaires: Heart rate variability parameters monitoring- by wearing a Polar watch (RS800CX). Isometric grip test- by using a Jamar Hand Held Dynamometer. Questionnaires: Dizziness Handicap Inventory (DHI) - hebrew version. Stait-Trait Anxiety Inventory (STAI)<br>* Other names: Questionnaires;|
| Subjects without BPPV (Control group)<br>Patients who do not suffer from dizziness / spinning sensation (Vertigo), and do not meet the exclusion criteria in the study. | Diagnostic Test: Heart rate variability parameters monitoring<br>* No intervention- only additional monitoring of heart rate, physical tests and filling of questionnaires: Heart rate variability parameters monitoring- by wearing a Polar watch (RS800CX). Isometric grip test- by using a Jamar Hand Held Dynamometer. Questionnaires: Dizziness Handicap Inventory (DHI) - hebrew version. Stait-Trait Anxiety Inventory (STAI)<br>* Other names: Questionnaires;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Variability- SDNN | Standard Deviation of the Normal to Normal intervals | Through study completion, approximately 1 year | 
| Heart Rate Variability- RMSSD | Root Mean Square of the Successive Differences | Through study completion, approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory | Dizziness Handicap Inventory score from the hebrew version of the questionnaire | Through study completion, approximately 1 year | 
| Stait- Trait Anxiety Inventory | Stait- Trait Anxiety Inventory score from the hebrew version of the questionnaire | Through study completion, approximately 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign Paroxysmal Positional Vertigo, BPPV, Vertigo, Autonomic Nervous System, Heart Rate Variability, Vestibulo Sympathetic Response, Vestibulo Sympathetic Reflex