Benign Paroxysmal Positional Vertigo (BPPV)NCT04935970
Metabolic Disorders and Vertigo
An observational study of Benign Paroxysmal Positional Vertigo (BPPV) and Vestibular Migraine, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
The purpose of investigation is to assess the levels of metabolic factors (hydroxyvitamin D, homocysteine) between patients with vestibular dysfunction of peripheral origin (BPPV) and central origin (vestibular migraine). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Migraine, Central Positional Vertigo
- What is being tested?
- diagnostic blood test and neuropsychological test
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 10 Dec 2019to 31 Aug 2022
- 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 80 years
- All sexes
- Adult, Older adult
Study population: patients from clinic with damage of peripheral and central origin
Who may be able to join
- Written informed consent of participation in the study;
- Age:over 18 years old
- complaints of dizziness and insteadiness
Who cannot join
- Severe cognitive impairment (dementia)
- Severe depression
- Syncopal paroxysms
- Epileptic seizures
- Orthostatic hypotension
- Severe arrhythmia, unstable angina pectoris, acute myocardial infarction
Show all 11Show fewer
- Pregnancy 8. Alcoholism, substance abuse and drug addiction
- Organic liver and kidney diseases with the development of functional disorders.
- Anemia (hemoglobin <10.5 g / dl for women and <11.5 g / dl for men)
- Active oncological process
- Demyelinating and neurodegenerative diseases.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Clinic of Neurology and Neurosurgery of I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow
Anna Bedenko, PhD student, +79164989851
About this study
Official title: Metabolic Disorders and Their Correction in Vertigo and Unsteadiness
The purpose of investigation is to assess the levels of metabolic factors (hydroxyvitamin D, homocysteine) between patients with vestibular dysfunction of peripheral origin (BPPV) and central origin (vestibular migraine). Also we will analyse another factors (such as anxiety and depression) and optimize therapeuthical approach accordingly with the data.
Read the detailed description
Dizziness causes up to 2 to 15% of primary neurological complaints. In some patients who have undergone acute vertigo, postural instability, persistent postural perceptual vertigo (PPPV) develops, while in other similar cases occurs full recovery. So, it is necessary to search for neurophysiological, metabolic and psychophysiological factors and associated premorbid conditions that affect the outcome of neurovestibular compensation.
The case-control study will include 2 groups of patients suffering from vertigo of central and peripherial etiology. First group is recruited with patients were diagnosed with peripherial vestibular disorders, such as benign paroxysmal positional vertigo (BPPV), Meniere disease, vestibular neuritis. The proposal number of subjects in the first group is about forty. The second group will consist of forty patients with central vestibular disfunction: vestibular migraine, central positional vertigo etc. The inclusion of patient with persistent postural perceptual dizziness is discussed. Patients will be tested for hydroxyvitamin D and homocysteine in serum using an enzyme-linked immunosorbent assay (ELISA). The perception of the severity of disability was assessed using the Dizziness scale Handicap Inventory (DHI). All patients will undergo psychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'sscale. Statistical analysis was carried out with the Statistical Analysis System (SAS) package. The relationships will be assessed using the chi squared test and logistic regression. The level of significance is set at p < 0.05. The methods for small samples (Mann-Whitney U ) will be used. It is presumed that differences in vitamin D levels beetween two groups will be considerable.
- Conditions
- Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Migraine, Central Positional Vertigo, Vestibular Neuritis, Meniere Disease
- Being tested
- diagnostic blood test, neuropsychological test
- Keywords
- Benign paroxysmal positional vertigo (BPPV), vestibular neuritis, vestibular migraine, central positional vertigo, Meniere disease, persistent postural-perceptual dizziness (PPPD), vitamin D deficiency, hyperhomocysteinaemia
- Medical subject headings
- Benign Paroxysmal Positional Vertigo, Vestibular Neuronitis, Meniere Disease, Vitamin D Deficiency, Hyperhomocysteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic blood testDiagnostic test
vitamin D deficiency/insufficiency reveal, hyperhomocysteinaemia reveal
neuropsychological testDiagnostic test
neuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale.
| Study group | Role | What they receive |
|---|---|---|
| patients with peripherial vestibular disorder | Forty patients with BPPV, vestibular neuritis or another peripherial vestibular disorder Receives: Diagnostic Test: diagnostic blood test; Diagnostic Test: neuropsychological test | |
| patients with central vestibular disorder | Forty patients vestibular disorder of central origin Receives: Diagnostic Test: diagnostic blood test; Diagnostic Test: neuropsychological test | |
| healthy controls | twenty healthy control without balance problems Receives: Diagnostic Test: diagnostic blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin D deficiency/insufficiency reveal
enzyme-linked immunosorbent assay (ELISA).
Measured: Through 1-6 months of diagnosis established.
hyperhomocysteinaemia reveal
enzyme-linked immunosorbent assay (ELISA).
Measured: Through 1-6 months of diagnosis established.
Secondary outcomes (1)
correlation between metabolic and neuropsychological disorders
neuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start10 Dec 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxysmal Positional Vertigo (BPPV)Studies 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
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Bedenko, PhD student, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935970
- Sponsor's protocol ID
- 16-19
- Status last verified
- Mar 2021
- First submitted
- 11 Apr 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I give my consent to provide actual study protocol. However, It is impossible to provide stastistical documents and primary patient's documentation (It is forbidden by Local Ethic Committee of Sechenov University)
Publications
Bedenko A.S., Antonenko L.М., Barinov A.N. Metabolic disorders in the pathogenesis of various causes of dizziness and instability // Annals of the Russian academy of medical sciences. - 2020. - Vol. 75. - N. 6. - P. 605-608. doi: 10.15690/vramn1244
Bedenko A.S. Vertigo in neurological practice: rare causes and difficult decisions. Medical alphabet. 2019;2(19):34-36. (In Russ.) https://doi.org/10.33667/2078-5631-2019-2-19(394)-34-36
Bedenko A.S. Metabolic factors in pathogenesis of migraine and unsteadiness. Medical alphabet. 2020;(33):18-20. (In Russ.) https://doi.org/10.33667/2078-5631-2020-33-18-20
Bedenko A.S. Vertigo caused by vestibular migraine: current problems of pathogenesis, diagnostics and therapy. Epilepsy and paroxysmal conditions. 2020;12(3):177-181. (In Russ.)https://doi.org/10.17749/2077-8333/epi.par.con.2020.032
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Disorders and Their Correction in Vertigo and Unsteadiness
- ClinicalTrials.gov ID
- NCT04935970
- Acronym / sponsor ID
- 16-19
- Conditions
- Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Migraine, Central Positional Vertigo, Vestibular Neuritis, Meniere Disease
- Keywords
- Benign paroxysmal positional vertigo (BPPV), vestibular neuritis, vestibular migraine, central positional vertigo, Meniere disease, persistent postural-perceptual dizziness (PPPD), vitamin D deficiency, hyperhomocysteinaemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 23 Jun 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.
The purpose of investigation is to assess the levels of metabolic factors (hydroxyvitamin D, homocysteine) between patients with vestibular dysfunction of peripheral origin (BPPV) and central origin (vestibular migraine). Also we will analyse another factors (such as anxiety and depression) and optimize therapeuthical approach accordingly with the data.
Detailed description
Dizziness causes up to 2 to 15% of primary neurological complaints. In some patients who have undergone acute vertigo, postural instability, persistent postural perceptual vertigo (PPPV) develops, while in other similar cases occurs full recovery. So, it is necessary to search for neurophysiological, metabolic and psychophysiological factors and associated premorbid conditions that affect the outcome of neurovestibular compensation.
The case-control study will include 2 groups of patients suffering from vertigo of central and peripherial etiology. First group is recruited with patients were diagnosed with peripherial vestibular disorders, such as benign paroxysmal positional vertigo (BPPV), Meniere disease, vestibular neuritis. The proposal number of subjects in the first group is about forty. The second group will consist of forty patients with central vestibular disfunction: vestibular migraine, central positional vertigo etc. The inclusion of patient with persistent postural perceptual dizziness is discussed. Patients will be tested for hydroxyvitamin D and homocysteine in serum using an enzyme-linked immunosorbent assay (ELISA). The perception of the severity of disability was assessed using the Dizziness scale Handicap Inventory (DHI). All patients will undergo psychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'sscale. Statistical analysis was carried out with the Statistical Analysis System (SAS) package. The relationships will be assessed using the chi squared test and logistic regression. The level of significance is set at p < 0.05. The methods for small samples (Mann-Whitney U ) will be used. It is presumed that differences in vitamin D levels beetween two groups will be considerable.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with peripherial vestibular disorder | – | Diagnostic Test: diagnostic blood test, Diagnostic Test: neuropsychological testForty patients with BPPV, vestibular neuritis or another peripherial vestibular disorder |
| patients with central vestibular disorder | – | Diagnostic Test: diagnostic blood test, Diagnostic Test: neuropsychological testForty patients vestibular disorder of central origin |
| healthy controls | – | Diagnostic Test: diagnostic blood testtwenty healthy control without balance problems |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients from clinic with damage of peripheral and central origin
Key inclusion criteria (3 listed)
- Written informed consent of participation in the study;
- Age:over 18 years old
- complaints of dizziness and insteadiness
Key exclusion criteria (11 listed)
- Severe cognitive impairment (dementia)
- Severe depression
- Syncopal paroxysms
- Epileptic seizures
- Orthostatic hypotension
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 |
|---|---|---|
| diagnostic blood testvitamin D deficiency/insufficiency reveal, hyperhomocysteinaemia reveal | Diagnostic test | healthy controls, patients with central vestibular disorder, patients with peripherial vestibular disorder |
| neuropsychological testneuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale. | Diagnostic test | patients with central vestibular disorder, patients with peripherial vestibular disorder |
Primary outcome
vitamin D deficiency/insufficiency reveal
Time frame: Through 1-6 months of diagnosis established.
enzyme-linked immunosorbent assay (ELISA).
hyperhomocysteinaemia reveal
Time frame: Through 1-6 months of diagnosis established.
enzyme-linked immunosorbent assay (ELISA).
1 secondary outcome
correlation between metabolic and neuropsychological disorders
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- BackgroundBedenko A.S., Antonenko L.М., Barinov A.N. Metabolic disorders in the pathogenesis of various causes of dizziness and instability // Annals of the Russian academy of medical sciences. - 2020. - Vol. 75. - N. 6. - P. 605-608. doi: 10.15690/vramn1244
- BackgroundBedenko A.S. Vertigo in neurological practice: rare causes and difficult decisions. Medical alphabet. 2019;2(19):34-36. (In Russ.) https://doi.org/10.33667/2078-5631-2019-2-19(394)-34-36
- BackgroundBedenko A.S. Metabolic factors in pathogenesis of migraine and unsteadiness. Medical alphabet. 2020;(33):18-20. (In Russ.) https://doi.org/10.33667/2078-5631-2020-33-18-20
- Results publicationBedenko A.S. Vertigo caused by vestibular migraine: current problems of pathogenesis, diagnostics and therapy. Epilepsy and paroxysmal conditions. 2020;12(3):177-181. (In Russ.)https://doi.org/10.17749/2077-8333/epi.par.con.2020.032
- Individual participant dataSharing planned: No. I give my consent to provide actual study protocol. However, It is impossible to provide stastistical documents and primary patient's documentation (It is forbidden by Local Ethic Committee of Sechenov University)
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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.
Anna Bedenko, PhD student principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov 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 Benign Paroxysmal Positional Vertigo (BPPV) and Vestibular Migraine, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 3 inclusion and 11 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 23 Jun 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 Russia. 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 Ludmila Antonenko, professor (89265774431, luda6917@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vitamin D deficiency/insufficiency reveal (time frame: Through 1-6 months of diagnosis established.). The study lists 2 primary outcomes in all. 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 NCT04935970, which also lists 4 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 23 Jun 2021.