The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Location status: Recruiting
Location contact
Ming Zhang, PhD
CONTACT
Yuan Wang, M.D.
CONTACT
NCT Number: NCT06228196
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Observational
Xi'an, Shaanxi, 710061, China
Location status: Recruiting
Ming Zhang, PhD
CONTACT
Yuan Wang, M.D.
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Simultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants.
Time frame: baseline and 1 and 6 months
The changes of brain volume (mm3) are evaluated by structural MRI
Time frame: baseline and 1 and 6 months
The changes of brain functional connectivity intensity are evaluated by functional MRI
Time frame: baseline and 1 and 6 months
Vertigo is assessed with the Dizziness Handicap Inventory (DHI Scale)
Time frame: baseline and 1 and 6 months
Vertigo is also assessed with the Activities-specific Balance Confidence Scale (ABC Scale)
Time frame: baseline and 1 and 6 months
Vertigo is also assessed with the Visual Vertigo Analogue Scale (VVAS)
Time frame: baseline and 1 and 6 months
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
Immunology-related index in the blood sample is superoxide dismutase (SOD)
Time frame: baseline and 1 and 6 months
Inflammatory index in the blood sample is neutrophils/lymphocytes
Time frame: baseline and 1 and 6 months
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
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
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
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
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
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
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
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.
Contact information is provided by the study sponsor or research team.
Ming Zhang, PhD
CONTACT
Yuan Wang, M.D.
CONTACT
First Affiliated Hospital Xi'an Jiaotong University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05863949
Avitaminosis, BPPV
View Trial DetailsNCT05634902
BPPV, Dizziness
Pasadena, California, United States
View Trial DetailsNCT05960786
BPPV, Benign Paroxysmal Positional Vertigo
Washington D.C., District of Columbia, United States
View Trial DetailsNCT05846711
BPPV, Benign Paroxysmal Positional Vertigo
Aalborg, North Denmark, Denmark
View Trial Details