Clinical trial NCT03867019: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Paroxysmal Positional Vertigo
Vertigo
Autonomic Nervous System
Keywords: Benign Paroxysmal Positional Vertigo
BPPV
Vertigo
Autonomic Nervous System
Heart Rate Variability
Vestibulo Sympathetic Response
Vestibulo Sympathetic Reflex
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2019-03-07
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with and without BPPV will be recruited to the study in an outpatient physiotherapy clinic (community sample), "Clalit Health Services", in Tel Aviv.

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.

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)

Primary outcomes:
measure: Heart Rate Variability- SDNN
timeFrame: Through study completion, approximately 1 year
measure: Heart Rate Variability- RMSSD
timeFrame: Through study completion, approximately 1 year
Secondary outcomes:
measure: Dizziness Handicap Inventory
timeFrame: Through study completion, approximately 1 year
measure: Stait- Trait Anxiety Inventory
timeFrame: Through study completion, approximately 1 year
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Horowitz Physiotherapy Clinic
Study officials:
affiliation: Clalit Health Services
name: Moshe Chaimoff, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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