Clinical trial NCT06228196: Cohort Study of Clinical and Neuroimaging Characteristics for BPPV Patients in China
Official title: Cohort Study of Clinical and Neuroimaging Characteristics for BPPV Patients in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: BPPV
Vertigo
Vertigo, Peripheral
Keywords: BPPV
residual dizziness
Vertigo
Neuroimaging
Epidemic
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of BPPV/Healthy subjects who have not had BPPV

Exclusion Criteria:

* History of organic diseases in central nervous system and mental disorder, such as tumors, infections, depressive disorder, schizophrenia, etc. Claustrophobic

Primary outcomes:
measure: Differences between patients with BPPV and control group in brain structure
timeFrame: baseline and 1 and 6 months
measure: Differences between two groups in brain function
timeFrame: baseline and 1 and 6 months
measure: Changes on vertigo symptoms
timeFrame: baseline and 1 and 6 months
measure: Changes on vertigo symptoms
timeFrame: baseline and 1 and 6 months
measure: Changes on vertigo symptoms
timeFrame: baseline and 1 and 6 months
measure: Difference in blood markers between the two groups
timeFrame: baseline and 1 and 6 months
measure: Difference in blood markers between the two groups
timeFrame: baseline and 1 and 6 months
measure: Difference in blood markers between the two groups
timeFrame: baseline and 1 and 6 months
Secondary outcomes:
measure: Differences in Fatigue between the two groups
timeFrame: baseline and 1 and 6 months
measure: Differences in Sleep between the two groups
timeFrame: baseline and 1 and 6 months
measure: Differences in cognition between the two groups
timeFrame: baseline and 1 and 6 months
measure: Differences in executive function between the two groups
timeFrame: baseline and 1 and 6 months
measure: Difference in anxiety between the two groups
timeFrame: baseline and 1 and 6 months
measure: Difference in depression between the two groups
timeFrame: baseline and 1 and 6 months
measure: Differences in verbal memory and working memory between the two groups
timeFrame: baseline and 1 and 6 months
measure: Differences in auditory attention between the two groups
timeFrame: baseline and 1 and 6 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Yuan Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: