Positional VertigoNCT05141734
Correlation Tests for Patients With Benign Paroxysmal Positional Vertigo
An observational study of Positional Vertigo and Reflexes, Vestibo-Ocular, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate whether there is a relationship between nystagmus intensity and vestibular-ocular reflex gains by comparing Videonystagmography and video head impulse test in patients with posterior semicircular canal-benign paroxysmal positional vertigo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Positional Vertigo, Reflexes, Vestibo-Ocular, Nystagmus Vestibular
- What is being tested?
- The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV)
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2019to 10 Jul 2020
- 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
- Adult, Older adult
Study population: The patients included in the study group were diagnosed with isolated benign paroxysmal positional vertigo (BPPV) according to clinical symptoms.
Who may be able to join
- Patients with isolated benign paroxysmal positional vertigo were included in the study group.
- The patients included in the control group were composed of those who did not complain of vertigo.
Who cannot join
- -Participants with a history of neuro-otologic disease, an orthopedic disease that prevents neck movements, and any disease or surgery that causes impairment in ocular movements were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Patients With Benign Paroxysmal Positional Vertigo With vHIT (Video Head Impulse Test) and VNG (Videonystagmography)
This study aimed to investigate whether there is a relationship between nystagmus intensity and vestibular-ocular reflex gains by comparing Videonystagmography and video head impulse test in patients with posterior semicircular canal-benign paroxysmal positional vertigo.
Read the detailed description
The aim of this study is to investigate the relationship between the vestibulo-ocular reflex (VOR) gains obtained by video Head Impulse Test (vHIT) and the slow phase velocity (SPV) of nystagmus in patients with benign paroxysmal positional vertigo (BPPV) originating from the posterior semicircular canal (PSCC).
The patients were included in two groups. The study group consisted of patients with isolated PSCC BPPV (PSCC-BPPV), and the control group consisted of age and gender-matched healthy individuals. VOR gains were measured by vHIT in both the study group and the control group. The SPV values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains.
- Being tested
- The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV)
- Keywords
- vestibular function tests, Head Impulse Test, semicircular canals
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV)Diagnostic test
The vestibulo-ocular reflex (VOR) gains were measured by video Head Impulse Test (vHIT) in both the study group and the control group. The slow phase velocity (SPV) values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains.
| Study group | Role | What they receive |
|---|---|---|
| BPPV (benign paroxysmal positional vertigo) | VOR gains were measured by vHIT in both the study group and the control group. The SPV values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains. Receives: Diagnostic Test: The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV) | |
| Control | VOR gains were measured by vHIT in both the study group and the control group. The SPV values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains. Receives: Diagnostic Test: The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of nystagmus intensity and vestibulo-ocular reflex gains in patients with benign paroxysmal positional vertigo
The vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV) of nystagmus were compared in patients with benign paroxysmal positional vertigo.
Measured: 2019-2010 (15 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start15 Apr 2019
- Primary completion11 Jan 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merih Onal, Selcuk University
- Investigators
- Merih Onal, MD, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141734
- Sponsor's protocol ID
- 2019/54
- Status last verified
- Nov 2021
- First submitted
- 19 Nov 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Onal M, Aygun A, Colpan B, Karakayaoglu H, Onal O. Correlation between nystagmus intensity and vestibular-ocular reflex gain in benign paroxysmal positional vertigo: A prospective, clinical study. J Vestib Res. 2023;33(2):115-125. doi: 10.3233/VES-220106.
PubMed 36776086
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients With Benign Paroxysmal Positional Vertigo With vHIT (Video Head Impulse Test) and VNG (Videonystagmography)
- ClinicalTrials.gov ID
- NCT05141734
- Acronym / sponsor ID
- 2019/54
- Keywords
- vestibular function tests, Head Impulse Test, semicircular canals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 11 Jan 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 2 Dec 2021 (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.
This study aimed to investigate whether there is a relationship between nystagmus intensity and vestibular-ocular reflex gains by comparing Videonystagmography and video head impulse test in patients with posterior semicircular canal-benign paroxysmal positional vertigo.
Detailed description
The aim of this study is to investigate the relationship between the vestibulo-ocular reflex (VOR) gains obtained by video Head Impulse Test (vHIT) and the slow phase velocity (SPV) of nystagmus in patients with benign paroxysmal positional vertigo (BPPV) originating from the posterior semicircular canal (PSCC).
The patients were included in two groups. The study group consisted of patients with isolated PSCC BPPV (PSCC-BPPV), and the control group consisted of age and gender-matched healthy individuals. VOR gains were measured by vHIT in both the study group and the control group. The SPV values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPPV (benign paroxysmal positional vertigo) | – | Diagnostic Test: The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV)VOR gains were measured by vHIT in both the study group and the control group. The SPV values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains. |
| Control | – | Diagnostic Test: The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV)VOR gains were measured by vHIT in both the study group and the control group. The SPV values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients included in the study group were diagnosed with isolated benign paroxysmal positional vertigo (BPPV) according to clinical symptoms.
Key inclusion criteria (2 listed)
- Patients with isolated benign paroxysmal positional vertigo were included in the study group.
- The patients included in the control group were composed of those who did not complain of vertigo.
Key exclusion criteria (1 listed)
- -Participants with a history of neuro-otologic disease, an orthopedic disease that prevents neck movements, and any disease or surgery that causes impairment in ocular movements were excluded from the study.
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 |
|---|---|---|
| The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV)The vestibulo-ocular reflex (VOR) gains were measured by video Head Impulse Test (vHIT) in both the study group and the control group. The slow phase velocity (SPV) values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains. | Diagnostic test | BPPV (benign paroxysmal positional vertigo), Control |
Primary outcome
Comparison of nystagmus intensity and vestibulo-ocular reflex gains in patients with benign paroxysmal positional vertigo
Time frame: 2019-2010 (15 months)
The vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV) of nystagmus were compared in patients with benign paroxysmal positional vertigo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Derived from this study: PubMed 36776086Onal M, Aygun A, Colpan B, Karakayaoglu H, Onal O. Correlation between nystagmus intensity and vestibular-ocular reflex gain in benign paroxysmal positional vertigo: A prospective, clinical study. J Vestib Res. 2023;33(2):115-125. doi: 10.3233/VES-220106.
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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.
Merih Onal, MD principal investigator
Selcuk University
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 Positional Vertigo and Reflexes, Vestibo-Ocular, run by Selcuk University 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 2 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of nystagmus intensity and vestibulo-ocular reflex gains in patients with benign paroxysmal positional vertigo (time frame: 2019-2010 (15 months)). 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 NCT05141734, which also lists 1 linked publication.
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 2 Dec 2021.