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

• Sponsor: Clalit Health Services (Other)
• Overall Status: Completed
• CT.gov ID: NCT03867019
• Collaborator: Tel Aviv University (Other)
• Enrollment: 36
• Location: 1
• Actual Duration (Months): 16.2
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Paroxysmal Positional Vertigo; Vertigo; Autonomic Nervous System	Diagnostic Test: Heart rate variability parameters monitoring

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 Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Cardiac Autonomic Control System Response to Vestibular Stimulation in Subjects With and Without BPPV
• Actual Study Start Date: Apr 28, 2019
• Actual Primary Completion Date: Sep 1, 2020
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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. Positive Dix-Hallpike / Supine Roll Test, confirmed by presence of nystagmus.	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: Dizziness Handicap Inventory (DHI) - hebrew version. Stait-Trait Anxiety Inventory (STAI); Other Names: Isometric grip test Five times sit to stand Questionnaires
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.	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: Dizziness Handicap Inventory (DHI) - hebrew version. Stait-Trait Anxiety Inventory (STAI); Other Names: Isometric grip test Five times sit to stand Questionnaires

Outcome Measures

Primary Outcome Measures

1. Heart Rate Variability- SDNN [Through study completion, approximately 1 year]

   Standard Deviation of the Normal to Normal intervals

2. Heart Rate Variability- RMSSD [Through study completion, approximately 1 year]

   Root Mean Square of the Successive Differences

Secondary Outcome Measures

1. Dizziness Handicap Inventory [Through study completion, approximately 1 year]

   Dizziness Handicap Inventory score from the hebrew version of the questionnaire

2. Stait- Trait Anxiety Inventory [Through study completion, approximately 1 year]

   Stait- Trait Anxiety Inventory score from the hebrew version of the questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Horowitz Physiotherapy Clinic	Tel Aviv		Israel

Sponsors and Collaborators

• Clalit Health Services
• Tel Aviv University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Dr. Moshe Chaimoff, Dr. Moshe Chaimoff, Otolaryngology specialist, Principal investigator, Clalit Health Services
• ClinicalTrials.gov Identifier: NCT03867019
• Other Study ID Numbers: 0179-18-COM1
• First Posted: Mar 7, 2019
• Last Update Posted: Jan 13, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Moshe Chaimoff, Dr. Moshe Chaimoff, Otolaryngology specialist, Principal investigator, Clalit Health Services: Benign Paroxysmal Positional Vertigo; BPPV; Vertigo; Autonomic Nervous System; Heart Rate Variability; Vestibulo Sympathetic Response; Vestibulo Sympathetic Reflex
• Additional relevant MeSH terms: Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness

Study Results

No Results Posted as of Jan 13, 2021