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

NCT05922774 | Unknown

• 1 other identifier: cVEMP in intractable BPPV
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

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

Outcome Measures

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.

  13 weeks

Study Arms (3)

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

Cervical VEMP testing DEVICE

cervical vestibular evoked myogenic potentials

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, 34096, Turkey (Türkiye)

RECRUITING

Related 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.

  PMID: 28031157 BACKGROUND

• 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.

  PMID: 24789801 BACKGROUND

• 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.

  PMID: 26857819 BACKGROUND

• 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.

  PMID: 26371697 BACKGROUND

• 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.

  PMID: 29687182 BACKGROUND

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Isil Taylan Cebi, M.D

CONTACT

00905072352256; drisiltaylan@hotmail.com

Abdullah Karatas, M.D

CONTACT

00905326230218; akrts2000@yahoo.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 28, 2023
• Study Start: June 19, 2023
• Primary Completion: December 25, 2023
• Study Completion: March 1, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)