An observational study in BPPV, Vertigo and Vertigo, Peripheral, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational
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.
187 studies on the registry are indexed under Vertigo; 27 are open to participants now.
This study's planned enrollment of 150 is below the median of 198 across 42 observational studies indexed under Vertigo.
Browse Vertigo studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Confirmed diagnosis of BPPV
Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum
Healthy subjects who have not had BPPV
Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum
Simultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants.
Differences between patients with BPPV and control group in brain structure
The changes of brain volume (mm3) are evaluated by structural MRI
Time frame: 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
Time frame: baseline and 1 and 6 months
Changes on vertigo symptoms
Vertigo is assessed with the Dizziness Handicap Inventory (DHI Scale)
Time frame: baseline and 1 and 6 months
Changes on vertigo symptoms
Vertigo is also assessed with the Activities-specific Balance Confidence Scale (ABC Scale)
Time frame: baseline and 1 and 6 months
Changes on vertigo symptoms
Vertigo is also assessed with the Visual Vertigo Analogue Scale (VVAS)
Time frame: 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）
Time frame: 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)
Time frame: baseline and 1 and 6 months
Difference in blood markers between the two groups
Inflammatory index in the blood sample is neutrophils/lymphocytes
Time frame: baseline and 1 and 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and 1 and 6 months
Started Jan 2024 (actual). Primary completion is estimated for Jun 2026, 29 months after the start.
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First Affiliated Hospital Xi'an Jiaotong University →