Cohort Study of Clinical and Neuroimaging Characteristics for BPPV Patients in China

NCT ID: NCT06228196

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-08

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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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

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BPPV Vertigo Vertigo, Peripheral

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BPPV patients

Confirmed diagnosis of BPPV

Simultaneous cortico-spinal magnetic resonance imaging, Serum

Intervention Type DEVICE

Simultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants.

Healthy controls

Healthy subjects who have not had BPPV

Simultaneous cortico-spinal magnetic resonance imaging, Serum

Intervention Type DEVICE

Simultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuan Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xian Jiaotong University

Locations

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The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuan Wang, M.D.

Role: CONTACT

0086-13324598144

Ming Zhang, PhD

Role: CONTACT

+8618991232265

Facility Contacts

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Yuan Wang, M.D.

Role: primary

0086-13324598144

Ming Zhang, PhD

Role: backup

0086-18991232265

Other Identifiers

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XJTU1AF2023LSK-566

Identifier Type: -

Identifier Source: org_study_id

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