NCT07472998

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

March 11, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

BPPVstressHRVheart rate variabilityBenign paroxysmal positional vertigo

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline (At the time of HRV assessment (single visit))

  • 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.

    Baseline (At the time of HRV assessment (single visit))

Secondary Outcomes (2)

  • Change in RMSSD During Controlled Breathing (ΔRMSSD)

    Baseline (single HRV assessment visit)

  • Change in COV RR During Controlled Breathing (ΔCOV RR)

    Baseline (single HRV assessment visit)

Study Arms (2)

BPPV Group

Patients diagnosed with benign paroxysmal positional vertigo (BPPV) based on positional testing in the otolaryngology clinic.

Other: Short-term HRV measurement

Healthy Control Group

Age-, sex-, and body mass index-matched healthy volunteers without a history of vestibular disorders

Other: Short-term HRV measurement

Interventions

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.

BPPV GroupHealthy Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicalpark Florya Hospital

Istanbul, Küçükçekmece, 34295, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersBenign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Mental DisordersVertigoVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Dastan Temirbekov, assistan professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistan Professor

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

April 1, 2026

Primary Completion

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations