BPPVBPPV-HRVNCT07472998
Heart Rate Variability in Benign Paroxysmal Positional Vertigo
An observational study of BPPV and Stress and Anxiety, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- BPPV, Stress and Anxiety
- What is being tested?
- Short-term HRV measurement
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medicalpark Florya Hospital
Istanbul, Küçükçekmece, 34295
Nilay Turğut, 5387175333 ext. +90, niba.1907@gmail.com
About this study
Official title: 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.
Read more
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.
- Conditions
- BPPV, Stress and Anxiety
- Being tested
- Short-term HRV measurement
- Keywords
- BPPV, stress, HRV, heart rate variability, Benign paroxysmal positional vertigo
- Medical subject headings
- Anxiety Disorders, Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-term HRV measurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| BPPV Group | Patients diagnosed with benign paroxysmal positional vertigo (BPPV) based on positional testing in the otolaryngology clinic. Receives: Other: Short-term HRV measurement | |
| Healthy Control Group | Age-, sex-, and body mass index-matched healthy volunteers without a history of vestibular disorders Receives: Other: Short-term HRV measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (At the time of HRV assessment (single visit))
Secondary outcomes (2)
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.
Measured: Baseline (single HRV assessment visit)
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).
Measured: Baseline (single HRV assessment visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPPVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dastan Temirbekov, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472998
- Sponsor's protocol ID
- IAU/BPPV/HRV/2026
- Acronym
- BPPV-HRV
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autonomic Function Using Short-Term Heart Rate Variability in Patients With Benign Paroxysmal Positional Vertigo: A Prospective Case-Control Study
- ClinicalTrials.gov ID
- NCT07472998
- Acronym / sponsor ID
- BPPV-HRV / IAU/BPPV/HRV/2026
- Conditions
- BPPV, Stress and Anxiety
- Keywords
- BPPV, stress, HRV, heart rate variability, Benign paroxysmal positional vertigo
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPPV Group | – | Other: Short-term HRV measurementPatients diagnosed with benign paroxysmal positional vertigo (BPPV) based on positional testing in the otolaryngology clinic. |
| Healthy Control Group | – | Other: Short-term HRV measurementAge-, sex-, and body mass index-matched healthy volunteers without a history of vestibular disorders |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-term HRV measurementShort-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. | Other | BPPV Group, Healthy Control Group |
Primary outcome
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.
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.
2 secondary outcomes
Change in RMSSD During Controlled Breathing (ΔRMSSD)
Time frame: Baseline (single HRV assessment visit)
Change in COV RR During Controlled Breathing (ΔCOV RR)
Time frame: Baseline (single HRV assessment visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BPPV and Stress and Anxiety, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
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 11 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 Apr 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dastan Temirbekov, assistan professor (05314013014 ext. +90, dasekeeee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root Mean Square of Successive Differences (RMSSD) (time frame: Baseline (At the time of HRV assessment (single visit))). 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?
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 16 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.