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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPPV patients | Confirmed diagnosis of BPPV |
| |
| Healthy controls | Healthy subjects who have not had BPPV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simultaneous cortico-spinal magnetic resonance imaging, Serum | Device | Simultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences between patients with BPPV and control group in brain structure | The changes of brain volume (mm3) are evaluated by structural MRI | 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 | baseline and 1 and 6 months |
| Changes on vertigo symptoms | Vertigo is assessed with the Dizziness Handicap Inventory (DHI Scale) | baseline and 1 and 6 months |
| Changes on vertigo symptoms | Vertigo is also assessed with the Activities-specific Balance Confidence Scale (ABC Scale) | baseline and 1 and 6 months |
| Changes on vertigo symptoms | Vertigo is also assessed with the Visual Vertigo Analogue Scale (VVAS) | 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） | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 1 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Wang, M.D. | Contact | 0086-13324598144 | wangyuan8003@126.com | |
| Ming Zhang, PhD | Contact | +8618991232265 | zmmri@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuan Wang, M.D. | First Affiliated Hospital of Xian Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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Whole blood
| baseline and 1 and 6 months |
| Difference in blood markers between the two groups | Inflammatory index in the blood sample is neutrophils/lymphocytes | 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. | 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. | 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). | 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. | 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. | 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. | 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. | baseline and 1 and 6 months |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |