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

Sponsor
Haseki Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05922774
Collaborator
(none)
70
1
8.4
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cervical VEMP testing

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
70 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of Cervical Vestibular Evoked Myogenic Potentials in Recurrent and Persistant Benign Paroxysmal Positional Vertigo
Actual Study Start Date :
Jun 19, 2023
Anticipated Primary Completion Date :
Dec 25, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Group 1

Patients with recurrent BPPV

Device: Cervical VEMP testing
cervical vestibular evoked myogenic potentials

Group 2

Patients with non recurrent BPPV

Device: Cervical VEMP testing
cervical vestibular evoked myogenic potentials

Group 3

Healthy controls

Device: Cervical VEMP testing
cervical vestibular evoked myogenic potentials

Outcome Measures

Primary Outcome Measures

  1. The findings of cVEMP test which was performed 4 weeks after the resolution of BPPV symptoms [13 weeks]

    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 these groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haseki Training and Research Hospital İstanbul Turkey 34096

Sponsors and Collaborators

  • Haseki Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ISIL TAYLAN CEBI, M.D., Haseki Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05922774
Other Study ID Numbers:
  • cVEMP in intractable BPPV
First Posted:
Jun 28, 2023
Last Update Posted:
Jun 28, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ISIL TAYLAN CEBI, M.D., Haseki Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 28, 2023