Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06228196
Other study ID # XJTU1AF2023LSK-566
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 8, 2024
Est. completion date September 30, 2026

Study information

Verified date February 2024
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Yuan Wang, M.D.
Phone 0086-13324598144
Email wangyuan8003@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Changes on vertigo symptoms Vertigo is assessed with the Dizziness Handicap Inventory (DHI Scale) baseline and 1 and 6 months
Primary Changes on vertigo symptoms Vertigo is also assessed with the Activities-specific Balance Confidence Scale (ABC Scale) baseline and 1 and 6 months
Primary Changes on vertigo symptoms Vertigo is also assessed with the Visual Vertigo Analogue Scale (VVAS) baseline and 1 and 6 months
Primary 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
Primary 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
Primary Difference in blood markers between the two groups Inflammatory index in the blood sample is neutrophils/lymphocytes baseline and 1 and 6 months
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Recruiting NCT05533840 - Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
Completed NCT02533739 - Vestibular Disorder and Visuo-spatial Functions N/A
Completed NCT01153789 - Study of Oculomotor Dysfunction Leading to Children Vertigo N/A
Completed NCT00765635 - Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal Phase 4
Not yet recruiting NCT04929444 - Training to Improve Vertigo Management in Primary Care N/A
Not yet recruiting NCT04055766 - A Diagnostic Test on DeepDoc-an AI-based Decision Support System
Completed NCT04458376 - Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness N/A
Recruiting NCT06332326 - Investigation of the Efficacy of Non-Invasive Vagus Nerve Stimulation and Physiotherapy in Unilateral Vestibular Hypofunction Patients N/A
Completed NCT02938221 - Telemedical Examination of a Three-Component Oculomotor Testing Battery N/A
Active, not recruiting NCT02655575 - Assessment and Treatment of Patients With Long-term Dizziness in Primary Care N/A
Completed NCT02457455 - Urgent Medical and Surgical Conditions During Flights N/A
Enrolling by invitation NCT01426932 - The Head Impulse Test in the Screening of Vestibular Function N/A
Completed NCT00000359 - Treatments for Benign Paroxysmal Positional Vertigo (BPPV) Phase 2
Not yet recruiting NCT06017466 - Translation and Implementation of the Dutch VVAS Score in Clinical Practice N/A
Not yet recruiting NCT06010550 - Validating a Clinical Decision Support Tool for Stratifying Stroke Risk for Dizziness/Vertigo
Completed NCT04598113 - Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients N/A
Completed NCT05157399 - Quantification of the Effect of the OtoBand on Objective Measures of Vertigo and Dizziness N/A
Completed NCT05897853 - Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness
Completed NCT05221892 - Evaluation of Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine and Cyanocobalamin as Therapy for Vertigo Phase 4