- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07472998
Heart Rate Variability in Benign Paroxysmal Positional Vertigo (BPPV-HRV)
Evaluation of Autonomic Function Using Short-Term Heart Rate Variability in Patients With Benign Paroxysmal Positional Vertigo: A Prospective Case-Control Study
Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder. Although the pathophysiology of BPPV is mainly attributed to the displacement of otoconia within the semicircular canals, recent studies suggest that psychological stress and anxiety may be associated with the onset or recurrence of the disease. However, the biological mechanisms underlying this relationship remain poorly understood, and objective evaluation of autonomic nervous system function in patients with BPPV is limited.
Heart rate variability (HRV) is a non-invasive method widely used to assess autonomic nervous system activity. Short-term HRV measurements provide information about autonomic balance and vagal tone. In particular, parameters such as the root mean square of successive differences (RMSSD) and the coefficient of variation of RR intervals (COV RR/R) are considered indicators of parasympathetic activity.
The aim of this prospective case-control study is to evaluate vagal tone in patients with BPPV using short-term HRV analysis and to compare the findings with age-, sex-, and body mass index-matched healthy controls. Participants will undergo standardized HRV measurements at rest and during controlled breathing. Perceived stress levels will also be assessed using the Perceived Stress Scale (PSS-10).
The primary outcomes of the study are RMSSD and the coefficient of variation of RR intervals (COV RR/R), obtained from short-term HRV recordings. These parameters will be compared between BPPV patients and healthy controls, and their associations with perceived stress levels will also be explored. The findings of this study may provide insights into the role of autonomic regulation and stress-related mechanisms in the pathophysiology of BPPV.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dastan Temirbekov, assistan professor
- Phone Number: +90 05314013014
- Email: dasekeeee@gmail.com
Study Locations
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Küçükçekmece
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Istanbul, Küçükçekmece, Turkey (Türkiye), 34295
- Recruiting
- Medicalpark Florya Hospital
-
Contact:
- Nilay Turğut
- Phone Number: +90 5387175333
- Email: niba.1907@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- BPPV Group
Age 18 years or older
Clinical diagnosis of benign paroxysmal positional vertigo (BPPV) confirmed by positional testing (Dix-Hallpike and/or Roll test) with positional nystagmus
No known history of cardiac disease
Ability and willingness to provide written informed consent
Healthy Control Group
Age 18 years or older
No history of vertigo or known vestibular disorder
Age- and sex-matched to the BPPV group
No known history of cardiac disease
Ability and willingness to provide written informed consent
Exclusion Criteria:
- Age younger than 18 years
Inability to provide informed consent or impaired mental capacity
Known arrhythmia, heart failure, ischemic heart disease, or other clinically significant cardiac disorder
Use of medications that may directly affect heart rate variability, including beta-blockers, non-dihydropyridine calcium channel blockers, antiarrhythmic drugs, digoxin, systemic corticosteroids, centrally acting sympatholytic agents, or psychotropic medications that may influence autonomic balance
Active infection or systemic inflammatory disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
BPPV Group
Patients diagnosed with benign paroxysmal positional vertigo (BPPV) based on positional testing in the otolaryngology clinic.
|
Short-term heart rate variability (HRV) assessment performed using a non-invasive device that records RR interval variability through hand electrodes.
Measurements will be obtained at rest and during controlled breathing to evaluate vagal tone and autonomic nervous system activity.
|
|
Healthy Control Group
Age-, sex-, and body mass index-matched healthy volunteers without a history of vestibular disorders
|
Short-term heart rate variability (HRV) assessment performed using a non-invasive device that records RR interval variability through hand electrodes.
Measurements will be obtained at rest and during controlled breathing to evaluate vagal tone and autonomic nervous system activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Root Mean Square of Successive Differences (RMSSD)
Time Frame: Baseline (At the time of HRV assessment (single visit))
|
Root Mean Square of Successive Differences (RMSSD), expressed in milliseconds (ms), obtained from short-term heart rate variability recordings using the UltraPro S100 EMG/NCS/EP Neurodiagnostic System.
RR interval variability will be recorded through hand electrodes during two conditions: resting state and controlled breathing (6 breaths per minute for 60 seconds).
RMSSD values will be compared between patients with benign paroxysmal positional vertigo (BPPV) and healthy control participants.
|
Baseline (At the time of HRV assessment (single visit))
|
|
Coefficient of Variation of RR Intervals (COV RR)
Time Frame: Baseline (At the time of HRV assessment (single visit))
|
Coefficient of variation of RR intervals (COV RR), expressed as percentage (%), derived from short-term heart rate variability recordings using the UltraPro S100 EMG/NCS/EP Neurodiagnostic System.
RR interval variability will be recorded through hand electrodes during resting conditions and controlled breathing (6 breaths per minute for 60 seconds).
COV RR values will be compared between patients with benign paroxysmal positional vertigo (BPPV) and healthy controls.
|
Baseline (At the time of HRV assessment (single visit))
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in RMSSD During Controlled Breathing (ΔRMSSD)
Time Frame: Baseline (single HRV assessment visit)
|
Change in Root Mean Square of Successive Differences (ΔRMSSD), expressed in milliseconds (ms), calculated as the difference between RMSSD measured during resting conditions and RMSSD measured during controlled breathing (6 breaths per minute for 60 seconds).
This measure reflects vagal reserve and autonomic responsiveness.
|
Baseline (single HRV assessment visit)
|
|
Change in COV RR During Controlled Breathing (ΔCOV RR)
Time Frame: Baseline (single HRV assessment visit)
|
Change in the coefficient of variation of RR intervals (ΔCOV RR), expressed as percentage points (%), calculated as the difference between COV RR measured during resting conditions and during controlled breathing (6 breaths per minute for 60 seconds).
|
Baseline (single HRV assessment visit)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IAU/BPPV/HRV/2026
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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