NCT03867019

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Clalit Health Services · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Benign Paroxysmal Positional Vertigo
• Vertigo
• Autonomic Nervous System

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Heart rate variability parameters monitoring	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: 1. Dizziness Handicap Inventory (DHI) - hebrew version. 2. Stait-Trait Anxiety Inventory (STAI)

Timeline

• Start date: 2019-04-28
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2019-03-07
• Last updated: 2021-01-13

Locations

1 site across 1 country: Israel