Heart Rate Variability in Benign Paroxysmal Positional Vertigo
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorIstanbul Aydın University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
BPPV Group
Disqualifiers
Age younger than 18 years
Trial population
The study population will consist of adult patients presenting to the otolaryngology outpatient clinic of Istanbul Aydın University Hospital with complaints of vertigo and diagnosed with benign paroxysmal positional vertigo (BPPV) based on clinical evaluation and positional testing (Dix-Hallpike and/or Roll test). The control group will include age- and sex-matched healthy volunteers without a history of vertigo or vestibular disorders. All participants will be recruited from individuals attending the same hospital during the study period.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Short-term HRV measurement
Other interventionShort-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.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: BPPV Group1 intervention
Group B: Healthy Control Group1 intervention
Trial outcomes
Primary outcomes
1
Root Mean Square of Successive Differences (RMSSD)
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.
Time frame
Baseline (At the time of HRV assessment (single visit))2
Coefficient of Variation of RR Intervals (COV RR)
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.
Time frame
Baseline (At the time of HRV assessment (single visit))Secondary outcomes
1
Change in RMSSD During Controlled Breathing (ΔRMSSD)
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.
Time frame
Baseline (single HRV assessment visit)2
Change in COV RR During Controlled Breathing (ΔCOV RR)
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).
Time frame
Baseline (single HRV assessment visit)Sponsors and contacts
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Source ClinicalTrials.gov