VertigodizzinessNCT07778901
China Dizziness and Vertigo Cohort Study （VERIDICAL STUDY）
An observational study of Vertigo and Vestibular Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 100 years
- Conditions the study is for
- Vertigo, Vestibular Diseases
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, The Second Affiliated Hospital, Zhejiang University School of Medicine, No.88 Jiefang Road
Hangzhou, Zhejiang, 310000
About this study
Official title: Epidemiological Investigation and Cohort Study of Vestibular Disorders in China
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.
Read the detailed description
This study is designed as a prospective, multicenter, real-world observational registry based on the Chinese Headache and Vertigo Registry System (CHRS), aiming to systematically characterize the etiological spectrum, diagnostic evolution, and clinical outcomes of patients presenting with dizziness and/or vertigo across neurology and otolaryngology outpatient settings in China. Participants will be consecutively or randomly enrolled from approximately 69 hospitals across more than 30 provinces, and all clinical data will be collected using standardized electronic case report forms within the CHRS platform. The registry integrates structured baseline assessments, including demographic characteristics, detailed clinical history, neurological and otological examinations, and standardized vestibular and audiological investigations, as well as validated patient-reported outcome measures. Etiological classification will be performed according to the Bárány Society International Classification of Vestibular Disorders consensus criteria, with supplementary classification based on ICD-11 when necessary. Longitudinal follow-up will be conducted at predefined time points up to 12 months, with extended follow-up allowed when clinically indicated, to evaluate diagnostic stability, symptom evolution, treatment response, and functional outcomes under routine clinical practice.
A comprehensive data management and quality assurance framework will be implemented. The CHRS registry will incorporate predefined data validation rules, including range checks, logical consistency checks, and cross-variable verification to ensure internal data integrity. Source data verification will be performed through periodic comparison of registry entries with medical records, imaging reports, and original clinical documentation at participating sites. A detailed data dictionary will be maintained, defining each variable, coding standards (including internationally recognized terminologies where applicable), and measurement scales. Standard Operating Procedures (SOPs) will govern all aspects of registry operations, including patient recruitment, informed consent, data entry, follow-up procedures, adverse event reporting, data monitoring, and protocol amendments. Site monitoring and auditing will be conducted periodically by independent reviewers to ensure protocol adherence and data accuracy.
Missing data will be managed according to predefined rules, including documentation of missingness mechanisms (e.g., unavailable, non-reported, or out-of-range values), and handled using appropriate statistical techniques such as multiple imputation or sensitivity analyses when applicable. Sample size determination is based on expected prevalence estimates and study precision requirements, with planned enrollment of approximately 6,000 participants to ensure adequate statistical power and representativeness. A detailed statistical analysis plan will be implemented, specifying descriptive analyses, comparative analyses, longitudinal modeling, and regression-based approaches to address primary and secondary objectives. All analyses will be conducted using validated statistical software, and results will be reported in accordance with relevant guidelines for observational registry studies.
- Conditions
- Vertigo, Vestibular Diseases
- Keywords
- Dizziness, Vestibular disease, vertigo, migraineurs vertigo
- Medical subject headings
- Vertigo, Vestibular Diseases, Dizziness
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Every follow-up time point of the research
Secondary outcomes (7)
Number of one more subsequent rescue-medication administrations after initial acute treatment
Calculation the number of subsequent rescue medication administration after initial acute treatment to evaluate the efficiency of specific treatment drug
Measured: Every follow-up time point of the research
The proportion of patient number whom whose moderate to severe vestibular symptom relieved completely
Calculation the proportion of patient number whom whose moderate to severe vestibular symptom relieved completely among all the patient population after initial acute drug therapy
Measured: In each specific follow-up time point
Time to full functional recovery after one vestibular symptom attack
Calculation the time window for the first rescue medication until patients achieve full recovery of abilities for daily living and work, this secondary outcome is also used to evaluate the efficiency of one specific acute therapy
Measured: In each follow-up time point
Reduction in scale scores related to vestibular symptoms and their associated symptoms compared to baseline scale scores
calculate numeric improvement in scale scores related to vestibular symptoms and their associated symptoms relative to baseline scores following acute treatment.
Measured: 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
Healthcare costs, transportation expenses, work-loss costs and other expenses incurred for the diagnosis and treatment of vestibular disease during the 1-year follow-up period.
Measured: The research end point in 12-month follow-up time point
The number of different adverse reactions related to any each of study treatment medication
Adverse reactions associated with administered therapeutic agents occurring in patients who receive pharmacological treatment following study enrolment.
Measured: In each follow-up time point from study enrolment until study termination.
The number of patients who keep using the prescribed preventive treatment medication
We calculate the proportion of patients continuing preventive medication during follow-up, care about the retention rate of each prophylactic drug
Measured: From initiation of preventive treatment until discontinuation of the preventive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaiming Liu, Doctor, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778901
- Sponsor's protocol ID
- 20260519
- Acronym
- dizziness
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available from the corresponding author upon reasonable request after publication, subject to approval by the study steering committee and institutional data sharing policies.
Publications
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.
PubMed 33285661Xing 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.
PubMed 38231268