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

Benign Paroxysmal Positional Vertigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05922774
• Other study ID #: cVEMP in intractable BPPV
• Status: Recruiting
• Start date: June 19, 2023
• Est. completion date: March 2024

Study information

• Verified date: July 2023
• Source: Haseki Training and Research Hospital
• Contact: Isil Taylan Cebi, M.D
• Phone: 00905072352256
• Email: drisiltaylan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2024
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Dizziness
• Vertigo

Intervention

Device:
• Cervical VEMP testing
cervical vestibular evoked myogenic potentials

Locations

Country	Name	City	State
Turkey	Haseki Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	13 weeks