Clinical trial NCT05922774: Cervical Vestibular Evoked Myogenic Potentials in Recurrent and Persistant Benign Paroxysmal Positional Vertigo
Official title: Evaluation of Cervical Vestibular Evoked Myogenic Potentials in Recurrent and Persistant Benign Paroxysmal Positional Vertigo
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Benign Paroxysmal Positional Vertigo
Keywords: Benign Paroxysmal Positional Vertigo
Cervical Vestibular Evoked Myogenic Potentials
Vestibular Function Tests
Saccule and Utricle
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18-65 years of age with first BPPV attack confirmed with VNG.

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: The comparison of cVEMP findings in normal controls and BPPV patients with nonrecurrent and recurrent BPPV symptoms after 4 week follow-up.
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Haseki Training and Research Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.