- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03867019
The Cardiac Autonomic Control System Response to Vestibular Stimulation in Subjects With and Without BPPV
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tel Aviv, Israel
- Horowitz Physiotherapy Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subjects with BPPV
Patients diagnosed with BPPV, who meet the following criteria:
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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:
Other Names:
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Subjects without BPPV (Control group)
Patients who do not suffer from dizziness / spinning sensation (Vertigo), and do not meet the exclusion criteria in the study.
|
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:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate Variability- SDNN
Time Frame: Through study completion, approximately 1 year
|
Standard Deviation of the Normal to Normal intervals
|
Through study completion, approximately 1 year
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Heart Rate Variability- RMSSD
Time Frame: Through study completion, approximately 1 year
|
Root Mean Square of the Successive Differences
|
Through study completion, approximately 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dizziness Handicap Inventory
Time Frame: Through study completion, approximately 1 year
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Dizziness Handicap Inventory score from the hebrew version of the questionnaire
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Through study completion, approximately 1 year
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Stait- Trait Anxiety Inventory
Time Frame: Through study completion, approximately 1 year
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Stait- Trait Anxiety Inventory score from the hebrew version of the questionnaire
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Through study completion, approximately 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Moshe Chaimoff, Dr., Clalit Health Services
Publications and helpful links
General Publications
- ▪ Bhattacharyya, N., Gubbels, S. P., Schwartz, S. R., Edlow, J. A., El-Kashlan, H., Fife, T., ... & Seidman, M. D. (2017). Clinical practice guideline: benign paroxysmal positional vertigo (update). Otolaryngology-Head and Neck Surgery, 156(3_suppl), S1-S47. ▪ Carter, J. R., & Ray, C. A. (2008). Sympathetic responses to vestibular activation in humans. American Journal of Physiology-Regulatory, Integrative and Comparative Physiology, 294(3), R681-R688. ▪ Ewing, D. J., & Clarke, B. F. (1982). Diagnosis and management of diabetic autonomic neuropathy. British medical journal (Clinical research ed.), 285(6346), 916. ▪ Ewing, D. J., Irving, J. B., Kerr, F., Wildsmith, J. A. W., & Clarke, B. F. (1974). Cardiovascular responses to sustained handgrip in normal subjects and in patients with diabetes mellitus: a test of autonomic function. Clinical Science, 46(3), 295-306. ▪ Fielder, H., Denholm, S. W., Lyons, R. A., & Fielder, C. P. (1996). Measurement of health status in patients with vertigo. Clinical Otolaryngology, 21(2), 124-126. ▪ Jacob, R. G., & Furman, J. M. (2001). Psychiatric consequences of vestibular dysfunction. Current opinion in Neurology, 14(1), 41-46. ▪ Jáuregui-Renaud, K., Aw, S. T., Todd, M. J., McGarvie, L. A., & Halmagyi, G. M. (2005). Benign paroxysmal positional vertigo can interfere with the cardiac response to head-down tilt. Otology & Neurotology, 26(3), 484-488. ▪ Jáuregui-Renaud, K., Hermosillo, A. G., Gómez, A., Márquez, M. F., Cárdenas, M., & Bronstein, A. M. (2003). Autonomic function interferes in cardiovascular reflexes. Archives of medical research, 34(3), 200-204. ▪ Julian, L. J. (2011). Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis care & research, 63(S11). ▪ Kaplan DM, Friger M, Racover NK, Peleg A, Kraus M, Puterman M. [The Hebrew dizziness handicap inventory]. Harefuah. 2010 Nov;149(11):697-700, 750, 749.Hebrew. PubMed PMID: 21250408 ▪ Khurana, R. K., & Setty, A. (1996). The value of the isometric hand-grip test-studies in various autonomic disorders. Clinical Autonomic Research, 6(4), 211-218. ▪ McCall, A. A., Miller, D. M., & Yates, B. J. (2017). Descending influences on vestibulospinal and vestibulosympathetic reflexes. Frontiers in neurology, 8, 112. ▪ Mutlu, B., & Serbetcioglu, B. (2013). Discussion of the dizziness handicap inventory. Journal of Vestibular Research, 23(6), 271-277. ▪ Nussinovitch, U., Elishkevitz, K. P., Katz, K., Nussinovitch, M., Segev, S., Volovitz, B., & Nussinovitch, N. (2011). Reliability of ultra-short ECG indices for heart rate variability. Annals of Noninvasive Electrocardiology, 16(2), 117-122. ▪ Ray, C. A. (2000). Interaction of the vestibular system and baroreflexes on sympathetic nerve activity in humans. American Journal of Physiology-Heart and Circulatory Physiology, 279(5), H2399-H2404. ▪ Schroeder, E. B., Whitsel, E. A., Evans, G. W., Prineas, R. J., Chambless, L. E., & Heiss, G. (2004). Repeatability of heart rate variability measures. Journal of electrocardiology, 37(3), 163-172. ▪ Sztajzel, J. (2004). Heart rate variability: a noninvasive electrocardiographic method to measure the autonomic nervous system. Swiss medical weekly, 134(35-36), 514-522. ▪ Yates, B. J., Bolton, P. S., & Macefield, V. G. (2014). Vestibulo-sympathetic responses. Comprehensive Physiology, 4(2), 851-887. ▪ Yates, B. J., & Bronstein, A. M. (2005). The effects of vestibular system lesions on autonomic regulation: observations, mechanisms, and clinical implications. Journal of Vestibular Research, 15(3), 119-129.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0179-18-COM1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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