BPPVNCT06228196
Cohort Study of Clinical and Neuroimaging Characteristics for BPPV Patients in China
An observational study of BPPV and Vertigo, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The main objective is to analyze the abnormality of physical condition, mental health and blood examination of the patients with benign paroxysmal positional vertigo (BPPV). Besides, the investigators aim to establish a database of BPPV based on multimodal magnetic resonance imaging data in the brain to identify… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- BPPV, Vertigo, Vertigo, Peripheral
- What is being tested?
- Simultaneous cortico-spinal magnetic resonance imaging, Serum
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2024to 30 Sep 2026
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will be carried out in the First Affiliated Hospital Xi'an Jiaotong University for patients who had diagnosis of BPPV by the Dix-Hallpike maneuver or Supine Roll test. The healthy control population will be searched in the primary care services, media and social networks. All participants will sign informed consent.
Who may be able to join
- Confirmed diagnosis of BPPV/Healthy subjects who have not had BPPV
Who cannot join
- History of organic diseases in central nervous system and mental disorder, such as tumors, infections, depressive disorder, schizophrenia, etc. Claustrophobic
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yuan Wang, M.D., 0086-13324598144, wangyuan8003@126.com
Ming Zhang, PhD, 0086-18991232265, zmmri@163.com
About this study
The main objective is to analyze the abnormality of physical condition, mental health and blood examination of the patients with benign paroxysmal positional vertigo (BPPV). Besides, the investigators aim to establish a database of BPPV based on multimodal magnetic resonance imaging data in the brain to identify high-risk patients with residual dizziness (RD) and systematically establish the comprehensive assessment system for the precise diagnosis, treatment and recovery of RD, optimize the tactics of BPPV management in China.
Read the detailed description
This is an observational, longitudinal, and single-center study. Confirmed BPPV cases will complete the following programs before and after 1 and 6 months of treatment for exploring biological mechanism and predictive biomarkers of BPPV: 1) fill in the behavioral psychological scales, 2) submit blood samples at a local laboratory, 3) receive 3 times brain MRI scan. The healthy controls will complete the same programs as BPPV-group mentioned above only at the time of inclusion. The investigators will establish the brain MRI database containing neuropsychological scales and blood parameters of BPPV in China.
- Conditions
- BPPV, Vertigo, Vertigo, Peripheral
- Being tested
- Simultaneous cortico-spinal magnetic resonance imaging, Serum
- Keywords
- BPPV, residual dizziness, Vertigo, Neuroimaging, Epidemic
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous cortico-spinal magnetic resonance imaging, SerumDevice
Simultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants.
| Study group | Role | What they receive |
|---|---|---|
| BPPV patients | Confirmed diagnosis of BPPV Receives: Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum | |
| Healthy controls | Healthy subjects who have not had BPPV Receives: Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between patients with BPPV and control group in brain structure
The changes of brain volume (mm3) are evaluated by structural MRI
Measured: baseline and 1 and 6 months
Differences between two groups in brain function
The changes of brain functional connectivity intensity are evaluated by functional MRI
Measured: baseline and 1 and 6 months
Changes on vertigo symptoms
Vertigo is assessed with the Dizziness Handicap Inventory (DHI Scale)
Measured: baseline and 1 and 6 months
Changes on vertigo symptoms
Vertigo is also assessed with the Activities-specific Balance Confidence Scale (ABC Scale)
Measured: baseline and 1 and 6 months
Changes on vertigo symptoms
Vertigo is also assessed with the Visual Vertigo Analogue Scale (VVAS)
Measured: baseline and 1 and 6 months
Difference in blood markers between the two groups
All subjects underwent fasting vein blood collection of about 5 ml at about 8 a.m. Blood indices related to BPPV and related clinical symptoms were screened, the inflammatory index is interleukin-6（IL-6）
Measured: baseline and 1 and 6 months
Difference in blood markers between the two groups
Immunology-related index in the blood sample is superoxide dismutase (SOD)
Measured: baseline and 1 and 6 months
Difference in blood markers between the two groups
Inflammatory index in the blood sample is neutrophils/lymphocytes
Measured: baseline and 1 and 6 months
Secondary outcomes (8)
Differences in Fatigue between the two groups
Fatigue is assessed with the Multidimensional Fatigue Inventory (MFI). A higher score represents a worse outcome. The MFI is a 20-item self-report instrument covering four dimensions (general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity) designed to measure fatigue.
Measured: baseline and 1 and 6 months
Differences in Sleep between the two groups
Sleep quality is assessed with Pittsburgh Sleep Quality Index (PSQI). A higher score corresponding to a worse sleep quality.
Measured: baseline and 1 and 6 months
Differences in cognition between the two groups
The cognition is assessed with Montreal Cognitive Assessment (MoCA). Higher scores (0-30) are related to a better performance.
Measured: baseline and 1 and 6 months
Differences in executive function between the two groups
The executive function is assessed with Trail Making Test A and B. Participants are asked to connect sequential numbers (TMT-A) and interconnect sequential numbers and letters (TMT-B).
Measured: baseline and 1 and 6 months
Difference in anxiety between the two groups
Anxiety is assessed with Beck Anxiety Inventory (BAI). A higher score corresponding to more severe anxiety symptoms.
Measured: baseline and 1 and 6 months
Difference in depression between the two groups
Depression is assessed with the Patient Health Questionnaire-9 (PHQ-9). A higher score corresponding to more severe depression symptoms.
Measured: baseline and 1 and 6 months
Differences in verbal memory and working memory between the two groups
Verbal memory is assessed with the Auditory Verbal Learning Test (AVLT). A 12-word list are read by examiner three times and participants are asked to recall them followed by each presentation, which was called "immediate recall". The "short delayed recall" and "long delayed recall" ask the participants to recall the above 12-word list 5 minutes and 20 minutes later, the correctly recalled number of words are recorded. Finally, the subjects are instructed to recognize the learned words from a 24-words list which consisted of above learned 12-words list and a new unlearned 12-words list. Working memory is assessed with the Digit Span Backward. Participants are asked to repeat the numbers in the reverse order the examiner read them aloud and a higher score corresponding to a better outcome.
Measured: baseline and 1 and 6 months
Differences in auditory attention between the two groups
Auditory attention is assessed with the Digit Span Forward. Participants are asked to repeat the numbers in the order the examiner read them aloud and a higher score corresponding to a better outcome.
Measured: baseline and 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start8 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPPVStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan Wang, M.D., Principal investigator, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228196
- Sponsor's protocol ID
- XJTU1AF2023LSK-566
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Clinical and Neuroimaging Characteristics for BPPV Patients in China
- ClinicalTrials.gov ID
- NCT06228196
- Acronym / sponsor ID
- XJTU1AF2023LSK-566
- Conditions
- BPPV, Vertigo, Vertigo, Peripheral
- Keywords
- BPPV, residual dizziness, Vertigo, Neuroimaging, Epidemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 29 Jan 2024 (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 main objective is to analyze the abnormality of physical condition, mental health and blood examination of the patients with benign paroxysmal positional vertigo (BPPV). Besides, the investigators aim to establish a database of BPPV based on multimodal magnetic resonance imaging data in the brain to identify high-risk patients with residual dizziness (RD) and systematically establish the comprehensive assessment system for the precise diagnosis, treatment and recovery of RD, optimize the tactics of BPPV management in China.
Detailed description
This is an observational, longitudinal, and single-center study. Confirmed BPPV cases will complete the following programs before and after 1 and 6 months of treatment for exploring biological mechanism and predictive biomarkers of BPPV: 1) fill in the behavioral psychological scales, 2) submit blood samples at a local laboratory, 3) receive 3 times brain MRI scan. The healthy controls will complete the same programs as BPPV-group mentioned above only at the time of inclusion. The investigators will establish the brain MRI database containing neuropsychological scales and blood parameters of BPPV in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPPV patients | – | Device: Simultaneous cortico-spinal magnetic resonance imaging, SerumConfirmed diagnosis of BPPV |
| Healthy controls | – | Device: Simultaneous cortico-spinal magnetic resonance imaging, SerumHealthy subjects who have not had BPPV |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will be carried out in the First Affiliated Hospital Xi'an Jiaotong University for patients who had diagnosis of BPPV by the Dix-Hallpike maneuver or Supine Roll test. The healthy control population will be searched in the primary care services, media and social networks. All participants will sign informed consent.
Key inclusion criteria (1 listed)
- Confirmed diagnosis of BPPV/Healthy subjects who have not had BPPV
Key exclusion criteria (1 listed)
- History of organic diseases in central nervous system and mental disorder, such as tumors, infections, depressive disorder, schizophrenia, etc. Claustrophobic
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 |
|---|---|---|
| Simultaneous cortico-spinal magnetic resonance imaging, SerumSimultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants. | Device | BPPV patients, Healthy controls |
Primary outcome
Differences between patients with BPPV and control group in brain structure
Time frame: baseline and 1 and 6 months
The changes of brain volume (mm3) are evaluated by structural MRI
Differences between two groups in brain function
Time frame: baseline and 1 and 6 months
The changes of brain functional connectivity intensity are evaluated by functional MRI
Changes on vertigo symptoms
Time frame: baseline and 1 and 6 months
Vertigo is assessed with the Dizziness Handicap Inventory (DHI Scale)
Changes on vertigo symptoms
Time frame: baseline and 1 and 6 months
Vertigo is also assessed with the Activities-specific Balance Confidence Scale (ABC Scale)
Changes on vertigo symptoms
Time frame: baseline and 1 and 6 months
Vertigo is also assessed with the Visual Vertigo Analogue Scale (VVAS)
Difference in blood markers between the two groups
Time frame: baseline and 1 and 6 months
All subjects underwent fasting vein blood collection of about 5 ml at about 8 a.m. Blood indices related to BPPV and related clinical symptoms were screened, the inflammatory index is interleukin-6（IL-6）
Difference in blood markers between the two groups
Time frame: baseline and 1 and 6 months
Immunology-related index in the blood sample is superoxide dismutase (SOD)
Difference in blood markers between the two groups
Time frame: baseline and 1 and 6 months
Inflammatory index in the blood sample is neutrophils/lymphocytes
8 secondary outcomes
Differences in Fatigue between the two groups
Time frame: baseline and 1 and 6 months
Differences in Sleep between the two groups
Time frame: baseline and 1 and 6 months
Differences in cognition between the two groups
Time frame: baseline and 1 and 6 months
Differences in executive function between the two groups
Time frame: baseline and 1 and 6 months
Difference in anxiety between the two groups
Time frame: baseline and 1 and 6 months
Difference in depression between the two groups
Time frame: baseline and 1 and 6 months
Differences in verbal memory and working memory between the two groups
Time frame: baseline and 1 and 6 months
Differences in auditory attention between the two groups
Time frame: baseline and 1 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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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.
Yuan Wang, M.D. principal investigator
First Affiliated Hospital of Xian Jiaotong 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 BPPV and Vertigo, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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 China. 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 Yuan Wang, M.D. (0086-13324598144, wangyuan8003@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between patients with BPPV and control group in brain structure (time frame: baseline and 1 and 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2024.