China Dizziness and Vertigo Cohort Study （VERIDICAL STUDY）

NCT07778901 | Active Not Recruiting DMC

• 1 other identifier: 20260519
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to characterize the clinical features, etiological distribution, and longitudinal outcomes of patients with dizziness and/or vertigo in real-world neurological and otolaryngological outpatient settings across China. The main questions it aims to answer are: What is the etiological spectrum of dizziness and vertigo in patients presenting to neurology and otolaryngology clinics in China, and how do diagnoses evolve over time under routine clinical practice? Additionally, how do symptoms, functional impairment, and treatment responses change during follow-up? Participants presenting with dizziness and/or vertigo who are already receiving routine clinical care at participating hospitals will be enrolled in a multicenter registry. They will undergo baseline clinical assessment and complete standardized questionnaires, and will be followed at predefined intervals for up to 12 months (with possible extended follow-up) through outpatient visits, electronic diaries, or telephone interviews to assess diagnostic stability, symptom progression, and treatment outcomes in a real-world setting.

Conditions

Vertigo; Vestibular Diseases

Keywords

Dizziness; Vestibular disease; vertigo; migraineurs vertigo

Outcome Measures

Primary Outcomes (5)

• Proportion of patient number with specific etiology of vestibular diseases

  For this outcome measure, we will calculate the proportion for the number of patients in each confirmed etiology of vestibular disease among the enrolled patient population or total patient count during a specific follow-up time

  In every research point of follow-up, and the extended follow-up period

• Proportion of patients with moderate-to-severe vestibular symptoms improving to mild severity

  Defined as the proportion of patients from whom their moderate-to-severe vestibular symptoms improve to mild severity within the specified time window after administration of appropriate first-line acute-phase therapeutic agents selected in accordance with recommendations from disease-specific treatment guidelines.

  In each time point to follow up within 12 months from study enrolment and during the extended follow-up phase. This proportion may be calculated for the same follow-up time period when rescue medication is administered.

• Reduction in days with vestibular symptoms relative to baseline vestibular symptom days

  The numeric reduction in the average number of days with vestibular symptom episodes during follow-up time point after a period of preventive treatment, compared with baseline.

  Every follow-up time point of the research

• Reduction in frequence of vestibular symptom episode relative to baseline vestibular symptom frequence

  The numeric reduction in the average number of frequence with vestibular symptom episodes during follow-up time point after a period of preventive treatment, compared with baseline.

  Every follow-up time point of the research

• Number of rescue-medication administrations during preventive treatment

  Number of rescue medications required for recurrent vestibular symptom episodes while on preventive medication.

  Every follow-up time point of the research

Secondary Outcomes (7)

• Number of one more subsequent rescue-medication administrations after initial acute treatment

  Every follow-up time point of the research

• The proportion of patient number whom whose moderate to severe vestibular symptom relieved completely

  In each specific follow-up time point

• Time to full functional recovery after one vestibular symptom attack

  In each follow-up time point

• Reduction in scale scores related to vestibular symptoms and their associated symptoms compared to baseline scale scores

  Within the time window of a single acute vestibular symptom episode and in each follow-up time

• The number of healthcare burden associated with vestibular disease-related diagnosis and treatment within 1-year follow-up

  The research end point in 12-month follow-up time point

Eligibility Criteria

• Age: 6 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 to 65 years presenting with dizziness and/or vertigo to neurology and otolaryngology outpatient clinics across approximately 70 hospitals in more than 30 provinces in China. Participants include both male and female patients with symptoms of spatial disorientation or balance disturbance, encompassing vertigo, dizziness, vestibular-visual symptoms, and postural instability. Eligible patients are enrolled consecutively or through predefined sampling strategies at the time of their first clinical visit and must provide written informed consent prior to participation. All participants undergo standardized baseline clinical evaluation and are followed in a real-world clinical setting without protocol-mandated interventions. The study population is intended to reflect routine clinical practice across different levels of healthcare institutions, including tertiary, secondary, and primary hospitals. Patients are subsequently followed lon

You may qualify if:

• Participants must meet all of the following criteria:a) Age between 18 and 65 years, inclusive;b) Male or female;c) Consecutive patients presenting to dizziness/vertigo outpatient clinics in the Departments of Neurology or Otolaryngology at 69 hospitals across more than 30 provinces in China, with symptoms of spatial orientation impairment or balance disturbance, including vertigo, dizziness, vestibular-visual symptoms, and postural symptoms;d) Ability and willingness to provide written informed consent

You may not qualify if:

• Inability to cooperate with essential diagnostic procedures, including medical history collection, physical examination, laboratory investigations, or other required evaluations, resulting in failure to establish a basic clinical diagnosis;b) Refusal or inability to provide written informed consent.

Sponsors & Collaborators

• Second Affiliated Hospital, Zhejiang University, School of Medicine: lead

Study Sites (1)

Department of Neurology, The Second Affiliated Hospital, Zhejiang University School of Medicine, No.88 Jiefang Road

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (2)

• Ruthberg JS, Rasendran C, Kocharyan A, Mowry SE, Otteson TD. The economic burden of vertigo and dizziness in the United States. J Vestib Res. 2021;31(2):81-90. doi: 10.3233/VES-201531.

  PMID: 33285661 BACKGROUND

• Xing Y, Si L, Zhang W, Wang Y, Li K, Yang X. Etiologic distribution of dizziness/vertigo in a neurological outpatient clinic according to the criteria of the international classification of vestibular disorders: a single-center study. J Neurol. 2024 May;271(5):2446-2457. doi: 10.1007/s00415-023-12166-3. Epub 2024 Jan 17.

  PMID: 38231268 BACKGROUND

MeSH Terms

Conditions

Vertigo; Vestibular Diseases; Dizziness

Condition Hierarchy (Ancestors)

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

Study Officials

• Kaiming Liu, Doctor

  Second Affiliated Hospital, Zhejiang University, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: August 21, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 21, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)