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

NCT06228196 | Recruiting

• 1 other identifier: XJTU1AF2023LSK-566
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

BPPV; Vertigo; Vertigo, Peripheral

Keywords

BPPV; residual dizziness; Vertigo; Neuroimaging; Epidemic

Outcome Measures

Primary Outcomes (8)

• 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)

  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

Secondary Outcomes (8)

• Differences in Fatigue between the two groups

  baseline and 1 and 6 months

• Differences in Sleep between the two groups

  baseline and 1 and 6 months

• Differences in cognition between the two groups

  baseline and 1 and 6 months

• Differences in executive function between the two groups

  baseline and 1 and 6 months

• Difference in anxiety between the two groups

  baseline and 1 and 6 months

Study Arms (2)

BPPV patients

Confirmed diagnosis of BPPV

Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum

Healthy controls

Healthy subjects who have not had BPPV

Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum

Interventions

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.

BPPV patients; Healthy controls

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuan Wang, M.D.

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Wang, M.D.

CONTACT

0086-13324598144; wangyuan8003@126.com

Ming Zhang, PhD

CONTACT

+8618991232265; zmmri@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 29, 2024
• Study Start: January 8, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

CN (1)