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Benign Paroxysmal Positional VertigoNCT03867019

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

An observational study of Benign Paroxysmal Positional Vertigo and Vertigo, run by Clalit Health Services at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 70 yearsHealthy volunteers can take part
What is being tested?
Heart rate variability parameters monitoring
How many people
36 participants
Where
1 siteIsrael
Study dates
28 Apr 2019to 1 Sep 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 12Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Horowitz Physiotherapy Clinic

    Tel Aviv

Other trials in Israel

About this study

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.

Read the 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.

Being tested
Heart rate variability parameters monitoring
Keywords
Benign Paroxysmal Positional Vertigo, BPPV, Vertigo, Autonomic Nervous System, Heart Rate Variability, Vestibulo Sympathetic Response, Vestibulo Sympathetic Reflex
Medical subject headings
Benign Paroxysmal Positional Vertigo, Vertigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heart rate variability parameters monitoringDiagnostic test

    Also called Isometric grip test, Five times sit to stand, Questionnaires

    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)
Study groups in NCT03867019
Study groupRoleWhat they receive
Subjects with BPPVPatients 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.
Receives: 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.
Receives: Diagnostic Test: Heart rate variability parameters monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart Rate Variability- SDNN

    Standard Deviation of the Normal to Normal intervals

    Measured: Through study completion, approximately 1 year

  2. Heart Rate Variability- RMSSD

    Root Mean Square of the Successive Differences

    Measured: Through study completion, approximately 1 year

Secondary outcomes (2)

  1. Dizziness Handicap Inventory

    Dizziness Handicap Inventory score from the hebrew version of the questionnaire

    Measured: Through study completion, approximately 1 year

  2. Stait- Trait Anxiety Inventory

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

    Measured: Through study completion, approximately 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2019
  2. Study start28 Apr 2019
  3. Primary completion1 Sep 2020
  4. Study completion1 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03867019
Sponsor's protocol ID
0179-18-COM1
Status last verified
Jan 2021
First submitted
5 Mar 2019
Last updated
13 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

Questions about this trial

What is this clinical trial studying?

An observational study of Benign Paroxysmal Positional Vertigo and Vertigo, run by Clalit Health Services at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate Variability- SDNN (time frame: Through study completion, approximately 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03867019, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.

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