An observational study in Benign Paroxysmal Positional Vertigo, Vertigo and Autonomic Nervous System, sponsored by Clalit Health Services. Completed at 1 site in Israel. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-13.
Sponsored by Clalit Health Services · Observational
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.
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:
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:
Non-parametric tests suitable for the analysis of the data in this study are:
Spearman coefficient will be used to examine correlations.
75 studies on the registry are indexed under Benign Paroxysmal Positional Vertigo; 15 are open to participants now.
This study's enrollment of 36 is below the median of 104 across 11 observational studies indexed under Benign Paroxysmal Positional Vertigo.
Browse Benign Paroxysmal Positional Vertigo studies →Clalit Health Services is the lead sponsor of 44 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with and without BPPV will be recruited to the study in an outpatient physiotherapy clinic (community sample), "Clalit Health Services", in Tel Aviv.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects with BPPV- Patients diagnosed with BPPV, who meet the following criteria:
Subjects without BPPV (Control group):
Subjects who do not suffer from dizziness / spinning sensation (Vertigo).
Exclusion Criteria:
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. 2. Positive Dix-Hallpike / Supine Roll Test, confirmed by presence of nystagmus.
Diagnostic Test: Heart rate variability parameters monitoring
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
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)
Also known as: Isometric grip test, Five times sit to stand, Questionnaires
Heart Rate Variability- SDNN
Standard Deviation of the Normal to Normal intervals
Time frame: Through study completion, approximately 1 year
Heart Rate Variability- RMSSD
Root Mean Square of the Successive Differences
Time frame: Through study completion, approximately 1 year
Dizziness Handicap Inventory
Dizziness Handicap Inventory score from the hebrew version of the questionnaire
Time frame: Through study completion, approximately 1 year
Stait- Trait Anxiety Inventory
Stait- Trait Anxiety Inventory score from the hebrew version of the questionnaire
Time frame: Through study completion, approximately 1 year
Plan to share: Undecided
Ran from Apr 2019 to primary completion in Sep 2020, 16 months.
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Clalit Health Services