An observational study in Vertigo and Vestibular Diseases, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Active, not recruiting at 1 site in China. Open to participants aged 6 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Observational
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.
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.
187 studies on the registry are indexed under Vertigo; 27 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 198 across 42 observational studies indexed under Vertigo.
Browse Vertigo studies →Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 99 studies on the registry; 67 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Every follow-up time point of the research
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From initiation of preventive treatment until discontinuation of the preventive
Plan to share: 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.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Second Affiliated Hospital, Zhejiang University, School of Medicine