The Influence of Vestibular Stimulation on Cardiac Autonomic Control System in Subjects With and Without BPPV

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Brief Title

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

Official Title

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

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:

        1. Patients with Benign Paroxysmal Positional Vertigo (BPPV).

        2. 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:

        1. Paired and unpaired t-tests.

        2. Repeated Measures Analysis of Variance (ANOVA).

      Non-parametric tests suitable for the analysis of the data in this study are:

        1. Mann-Whitney.

        2. Wilcoxon.

      Spearman coefficient will be used to examine correlations.
    


Study Type

Observational


Primary Outcome

Heart Rate Variability- SDNN

Secondary Outcome

 Dizziness Handicap Inventory

Condition

Benign Paroxysmal Positional Vertigo

Intervention

Heart rate variability parameters monitoring

Study Arms / Comparison Groups

 Subjects with BPPV
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

36

Start Date

April 28, 2019

Completion Date

September 1, 2020

Primary Completion Date

September 1, 2020

Eligibility Criteria

        Inclusion Criteria:

        Subjects with BPPV- Patients diagnosed with BPPV, who meet the following criteria:

          1. 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.)

          2. 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)
      

Gender

All

Ages

30 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Moshe Chaimoff, Dr., , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT03867019

Organization ID

0179-18-COM1


Responsible Party

Principal Investigator

Study Sponsor

Clalit Health Services

Collaborators

 Tel Aviv University

Study Sponsor

Moshe Chaimoff, Dr., Principal Investigator, Clalit Health Services


Verification Date

January 2021