Diagnostic Work up and Management of Acute Onset Vertigo

NCT05062915 | Active Not Recruiting DMC

• 1 other identifier: 20/12302
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Incidence: Dizziness or vertigo is a very prevalent complaint in the general population, and a common reason for seeking medical attention. In Denmark, 20-30 % have experienced dizziness/vertigo to a degree that has led to disability, sick leave, or medical contact(1). In the United States, dizziness is estimated to account for partly 2.6-4.4 million visits to emergency departments (EDs) each year, partly 4 % of main symptoms in patients admitted to EDs (2). In Germany, the estimated prevalence of dizziness is 20-30 % with an annual incidence about 11 % (3). Terminology and definition: Dizziness or vertigo is not a disease itself but rather a symptom of various underlying disorders. Thus, vestibular, neurological, cardiovascular, metabolic, and psychiatric diseases may be associated with dizziness/vertigo as well as medical side effects. Patients (and professionals) often use the two terms dizziness and vertigo synonymously, which may cause some confusion in the choice of diagnostics. Vertigo is characteristic for vestibular disorders and is defined as sensation of self-motion when no self-motion occurs, or sensation of distorted self-motion during an otherwise normal head movement, whereas dizziness is a feeling of more general unsteadiness.

1. 1.Is implementation of HINTS and v-HIT in an ED able to reduce the number of undiagnosed and misdiagnosed cases of acute onset vertigo as well as diagnostic delay ?
2. 2.What are the effects of immediate and systematic balance training in case of acute vestibular diseases ?
3. 3.What is the cost-effectiveness of implementation of HINTS and v-HIT as up front diagnostics, and systematic balance training in patients with acute vestibular diseases ?

Conditions

Acute Vestibular Syndrome; Vertigo

Outcome Measures

Primary Outcomes (4)

• Number of undiagnosed and misdiagnosed cases

  cases in the two populations is calculated at the time of discharge from ED. Definitions: Undiagnosed: cases without specific ICD10 code explaining acute dizziness/vertigo. Misdiagnosed: cases in which the chart review (baseline population) reveals obviously wrong ICD10 codes/post-hospital examinations reveal the specific cause of dizziness/vertigo; or ENT-examination within 24 hours changes the primary diagnosis (study population 1).

  1,5 years

• Percentage of patients undergoing HINTS in the baseline population

  Percentage of patients undergoing HINTS in the baseline population, and percentage of patients undergoing HINTS and v-HIT in study population 1.

  1 year

• Percentage of patients with complete recovery

  Percentage of patients with complete recovery one year after the acute attack defined as resumption of all daily day activities. Degree of vestibular deficit scored by the DHI questionnaire. Vestibular status in baseline population 2 (12 months after admission) is compared to vestibular status at one year follow up in study population 2 in terms of HINTS, v-HIT, VNG, posturography.

  1,5 years

• Cost-effectiveness of implementing up front diagnostics and balance training in patients with acute onset dizziness

  To examine the cost-effectiveness of up front diagnostics and balance training in prospective cohorts of patients with acute onset dizziness compared to a historical control group. A cost-effectiveness analysis will be conducted. Costing: The costs of up front diagnosis and balance training will be estimated using micro-costing. Use of primary healthcare services will be extracted and valued from the Danish National Health Service Register for Primary Care (NHSR). Use of secondary healthcare services will be extracted from the National Patient Registry (NPR). Productivity loss will be extracted from the Danish Register for Evaluation of Marginalization (DREAM) and valued by age- and gender-matched average gross salaries from Statistics Denmark (www.dst.dk).

  1 years

Secondary Outcomes (2)

• Time to correct diagnosis

  1,5 years

• Vestibular status in study population 2 at admission and at one year follow up are compared. Progression through the balance training program is evaluated by change in vestibular status

  2,5 years

Study Arms (2)

Baseline population

NO INTERVENTION

Historic cohorte for comparisson in study 1. Baseline population 1 all patients with AVS. Baseline 2 population part of baseline 1 but with peripheral cause of AVS. Are offered late onset vestibular rehabilitaion if they have balance deficit.

Study population

ACTIVE COMPARATOR

The study population is divided into 2 groups, based on the findings in the clinical investigation. study population 1: all patients with acute Vestibular syndrome (AVS) Study population 2: all patients from study group 1, with vestibular/peripheral cause of AVS. They are offered early onset rehabilitation. Arm 1 and 2 are compared for cost-effectiveness and compared to the costs of the diagnosis.

Diagnostic Test: HINTS

Interventions

HINTS DIAGNOSTIC_TEST

HINTS (Head Impulse, Nystagmus, test of skew) V-HIT (Head impulse test google assisted) MRI: 3-4 MRI of the brain including the posterior fossa Vestibular rehabilitation for all patients with a vestibular deficit.

Also known as: V-VHIT, MRI

Study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• patients with known vestibular disease, vestibular symptoms lasting more than two days.

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead

Study Sites (1)

Hospital South West Jutland

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

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

Study Officials

• Helle Agger-Nielsen, dr.

  SVS - Sydvestjysk sygehus, Øre, næse og hals afdelingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Bloc randomisation done by a physical therapist: only for the part of the study with vestibular rehabilitation
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Step 1:A prospective cohort of patients with acute Vestibular Syndrome (AVS) is compared to a baseline (historical) cohort. For a period of 1 year all patients with AVS are registred (baseline population 1) after 1 year their chart is reviewed and those with peripheral AVS (baseline population 2) are invited for a follow up. Those patients in the baseline population 2 who still has a balancedeficit are offered late onset vestibular rehabilitation. Step 2: all patients admitted with AVS are enrolled as Study population 1, all have balancetesting (V-HIT, HINTS, Posturography and MRI) done upfront. From study population 1, the patients with peripheral AVS (study population 2) are offered (besides the workup with V-Hit and MRI) a vestibular rehabilitation programme (early onset rehabilitation).

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 30, 2021
• Study Start: June 1, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)