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RecruitingNCT05922774Updated Jul 20, 2023

Cervical Vestibular Evoked Myogenic Potentials in Recurrent and Persistant Benign Paroxysmal Positional Vertigo

An observational study in Benign Paroxysmal Positional Vertigo, sponsored by Haseki Training and Research Hospital. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-20.

Sponsored by Haseki Training and Research Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
70
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The goal of this observational study is to compare the cervical vestibular evoked myogenic potentials in recurrent/persistant BPPV and nonrecurrent BPPV. Recurrent/persistant BPPV is considered as the patients who require more than one repositioning manuever for the resolution of symptoms and the recurrent cases in the first three months after the diagnosis.

The main question[s] it aims to answer are:

  • Is there any difference between the cVEMP findings of diseased ears of recurrent and nonrecurrent BPPV cases?
  • Is there any difference between the cVEMP findings of diseased ears and healthy ears of BPPV patients
  • Is there any difference between the cVEMP findings of healthy ears of recurrent and nonrecurrent BPPV cases and healthy controls?

Patients with VNG confirmed BPPV will be recruited and CVEMP test will be performed before the therapeutic manuevers.

Control visits will be scheduled on the 7th day after the therateutic menuevers are performed.

Patients will be followed-up for 4 weeks after the resolution of symptoms. Researchers will compare recurrent (Group 1), nonrecurrent (group 2) BPPV patients and healthy controls (Group 3) to see if there is any difference between the cVEMP findings of two groups.

02

Conditions studied

  • Benign Paroxysmal Positional Vertigo

Keywords

  • Benign Paroxysmal Positional Vertigo
  • Cervical Vestibular Evoked Myogenic Potentials
  • Vestibular Function Tests
  • Saccule and Utricle
03

In context

Benign Paroxysmal Positional Vertigo

75 studies on the registry are indexed under Benign Paroxysmal Positional Vertigo; 15 are open to participants now.

This study's planned enrollment of 70 is below the median of 104 across 11 observational studies indexed under Benign Paroxysmal Positional Vertigo.

Browse Benign Paroxysmal Positional Vertigo studies →

Lead sponsor

Haseki Training and Research Hospital is the lead sponsor of 78 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients 18-65 years of age with first BPPV attack confirmed with VNG.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients admitted to ENT clinic with unilateral posterior or lateral canal BPPV for the first time

Exclusion criteria

Exclusion Criteria:

  • patients with bilateral BPPV
  • patients with recurrent or resistant BPPV
  • patients with spontaneous nystagmus
  • vestibular or neurologic disorders other than BPPV
  • patients who use medication which may affect the vestibular system or muscle tone
  • cervical muscle disorders and ocular pathologies which may affect the VEMP results
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
70 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Group 1

    Patients with recurrent BPPV

    Device: Cervical VEMP testing

  • Group 2

    Patients with non recurrent BPPV

    Device: Cervical VEMP testing

  • Group 3

    Healthy controls

    Device: Cervical VEMP testing

Interventions

  • DeviceCervical VEMP testing

    cervical vestibular evoked myogenic potentials

06

What researchers measure

Primary outcomes

  1. The comparison of cVEMP findings in normal controls and BPPV patients with nonrecurrent and recurrent BPPV symptoms after 4 week follow-up.

    Patients with VNG confirmed BPPV will be recruited and CVEMP test will be performed before the therapeutic manuevers. Control visits will be scheduled on the 7th day after the therapeutic menuevers are performed. Patients will be followed-up for 4 weeks after the resolution of symptoms. Researchers will compare recurrent (Group 1), nonrecurrent (group 2) BPPV patients and healthy controls (Group 3) to see if there is any difference between the cVEMP findings of these groups.

    Time frame: 13 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Karatas A, Yuce T, Cebi IT, Acar Yuceant G, Haci C, Salviz M. Evaluation of Cervical Vestibular-Evoked Myogenic Potential Findings in Benign Paroxysmal Positional Vertigo. J Int Adv Otol. 2016 Dec;12(3):316-320. doi: 10.5152/iao.2016.2170. Epub 2016 Aug 1. PubMed 28031157 ↗
  • Yetiser S, Ince D, Gul M. An analysis of vestibular evoked myogenic potentials in patients with benign paroxysmal positional vertigo. Ann Otol Rhinol Laryngol. 2014 Oct;123(10):686-95. doi: 10.1177/0003489414532778. Epub 2014 May 1. PubMed 24789801 ↗
  • Xu H, Liang FY, Chen L, Song XC, Tong MC, Thong JF, Zhang QQ, Sun Y. Evaluation of the utricular and saccular function using oVEMPs and cVEMPs in BPPV patients. J Otolaryngol Head Neck Surg. 2016 Feb 9;45:12. doi: 10.1186/s40463-016-0125-7. PubMed 26857819 ↗
  • Kim EJ, Oh SY, Kim JS, Yang TH, Yang SY. Persistent otolith dysfunction even after successful repositioning in benign paroxysmal positional vertigo. J Neurol Sci. 2015 Nov 15;358(1-2):287-93. doi: 10.1016/j.jns.2015.09.012. Epub 2015 Sep 5. PubMed 26371697 ↗
  • Vaduva C, Esteban-Sanchez J, Sanz-Fernandez R, Martin-Sanz E. Prevalence and management of post-BPPV residual symptoms. Eur Arch Otorhinolaryngol. 2018 Jun;275(6):1429-1437. doi: 10.1007/s00405-018-4980-x. Epub 2018 Apr 23. PubMed 29687182 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2023 (actual). Primary completion is estimated for Dec 2023, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 19, 2023
First posted
Jun 28, 2023
StartActual
Jun 19, 2023
Primary completionEst.
Dec 25, 2023
CompletionEst.
Mar 2024
Last update
Jul 20, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05922774
Lead sponsor
Haseki Training and Research Hospital
Responsible party
ISIL TAYLAN CEBI (principal investigator, Haseki Training and Research Hospital) — Principal investigator
First posted
Jun 28, 2023
Start date
Jun 19, 2023
Primary completion
Dec 25, 2023 (estimated)
Completion
Mar 2024 (estimated)
Last update
Jul 20, 2023

Study contacts

Isil Taylan Cebi, M.D
Contact
drisiltaylan@hotmail.com
00905072352256
Abdullah Karatas, M.D
Contact
akrts2000@yahoo.ca
00905326230218

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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