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

NCT03867019 | Completed

• 1 other identifier: 0179-18-COM1
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Heart Rate Variability- SDNN

  Standard Deviation of the Normal to Normal intervals

  Through study completion, approximately 1 year

• Heart Rate Variability- RMSSD

  Root Mean Square of the Successive Differences

  Through study completion, approximately 1 year

Secondary Outcomes (2)

• Dizziness Handicap Inventory

  Through study completion, approximately 1 year

• Stait- Trait Anxiety Inventory

  Through study completion, approximately 1 year

Study Arms (2)

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. 2. Positive Dix-Hallpike / Supine Roll Test, confirmed by presence of nystagmus.

Diagnostic Test: Heart rate variability parameters monitoring

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

Interventions

Heart rate variability parameters monitoring DIAGNOSTIC_TEST

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

Subjects with BPPV; Subjects without BPPV (Control group)

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clalit Health Services: lead
• Tel Aviv University: collaborator

Study Sites (1)

Horowitz Physiotherapy Clinic

Tel Aviv, Israel

Location

Related Publications (1)

• ▪ 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.

  BACKGROUND

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Vertigo

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Moshe Chaimoff, Dr.

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Moshe Chaimoff, Otolaryngology specialist, Principal investigator

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: April 28, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

IL (1)