Benign Paroxysmal Positional VertigoNCT05922774
Cervical Vestibular Evoked Myogenic Potentials in Recurrent and Persistant Benign Paroxysmal Positional Vertigo
An observational study of Benign Paroxysmal Positional Vertigo, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- What is being tested?
- Cervical VEMP testing
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2023to Mar 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients 18-65 years of age with first BPPV attack confirmed with VNG.
Who may be able to join
- Patients admitted to ENT clinic with unilateral posterior or lateral canal BPPV for the first time
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Haseki Training and Research Hospital
Istanbul, 34096
Isil Taylan Cebi, M.D, 00905072352256, drisiltaylan@hotmail.com
About this study
Official title: Evaluation of Cervical Vestibular Evoked Myogenic Potentials in Recurrent and Persistant Benign Paroxysmal Positional Vertigo
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:
Read more
- 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
- Being tested
- Cervical VEMP testing
- Keywords
- Benign Paroxysmal Positional Vertigo, Cervical Vestibular Evoked Myogenic Potentials, Vestibular Function Tests, Saccule and Utricle
- Medical subject headings
- Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical VEMP testingDevice
cervical vestibular evoked myogenic potentials
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with recurrent BPPV Receives: Device: Cervical VEMP testing | |
| Group 2 | Patients with non recurrent BPPV Receives: Device: Cervical VEMP testing | |
| Group 3 | Healthy controls Receives: Device: Cervical VEMP testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start19 Jun 2023
- Primary completion25 Dec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ISIL TAYLAN CEBI, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922774
- Sponsor's protocol ID
- cVEMP in intractable BPPV
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28031157Yetiser 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 24789801Xu 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 26857819Kim 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 26371697Vaduva 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cervical Vestibular Evoked Myogenic Potentials in Recurrent and Persistant Benign Paroxysmal Positional Vertigo
- ClinicalTrials.gov ID
- NCT05922774
- Acronym / sponsor ID
- cVEMP in intractable BPPV
- Conditions
- Benign Paroxysmal Positional Vertigo
- Keywords
- Benign Paroxysmal Positional Vertigo, Cervical Vestibular Evoked Myogenic Potentials, Vestibular Function Tests, Saccule and Utricle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 25 Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Cervical VEMP testingPatients with recurrent BPPV |
| Group 2 | – | Device: Cervical VEMP testingPatients with non recurrent BPPV |
| Group 3 | – | Device: Cervical VEMP testingHealthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18-65 years of age with first BPPV attack confirmed with VNG.
Key inclusion criteria (1 listed)
- Patients admitted to ENT clinic with unilateral posterior or lateral canal BPPV for the first time
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical VEMP testingcervical vestibular evoked myogenic potentials | Device | Group 1, Group 2, Group 3 |
Primary outcome
The comparison of cVEMP findings in normal controls and BPPV patients with nonrecurrent and recurrent BPPV symptoms after 4 week follow-up.
Time frame: 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 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 28031157Karatas 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.
- Background: PubMed 24789801Yetiser 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.
- Background: PubMed 26857819Xu 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.
- Background: PubMed 26371697Kim 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.
- Background: PubMed 29687182Vaduva 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Paroxysmal Positional Vertigo, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isil Taylan Cebi, M.D (00905072352256, drisiltaylan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The comparison of cVEMP findings in normal controls and BPPV patients with nonrecurrent and recurrent BPPV symptoms after 4 week follow-up. (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922774, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.