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Unravelling Risk Factors for Chronic Dizziness in Patients After an Acute Unilateral Vestibular Deafferentiation.
Study Purpose
In many patients with an acute unilateral vestibular deafferentiation (uVD) syndrome symptoms are expected to resolve spontaneously because of central compensation. However, more detailed observations have revealed that 29-66 % of uVD patients develop disabling chronic dizziness lasting >1 year after the acute event. Identifying predictors of chronic dizziness would allow patients at high risk to be targeted with personalized therapies to reduce healthcare costs. Therefore, the main objective of this study is to identify predictors of chronic dizziness after an acute uVD. Despite the consensus on the usefulness of physical therapy, incorporation of physical therapy programs in daily management of patients after acute uVD remains troublesome. Therefore, the first objective is to study the effect of the actual level of physical activity in the acute stage on long term (LT) outcome. Recent data show that LT prognosis is more linked to anxiety and somatization traits than to objective vestibular findings. Therefore, the second objective is to study the effect of activities avoidance behavior on LT outcome. As stated above it is questioned whether objective vestibular findings can predict chronicity. However recently the Perez and Rey(PR) score was developed. Therefore, the third objective is to study the effect of early central vestibular compensation as measured by the PR score on LT outcome. In patients with poor central vestibular compensation the remaining sensory cues will need to compensate for the loss of vestibular information. Patients using a visual compensation strategy can become dependent of stable visual cues. Therefore, the fourth objective is to study the effect of visual motion sensitivity on LT outcome. A 2-year prospective cohort study will be performed to study aforementioned risk factors for chronic dizziness. Up to 200 consecutive patients with an acute uVD will be included. Chronic dizziness is indicated by a score >30 on the Dizziness Handicap Inventory (primary outcome) after 6 months. Possible risk factors will be evaluated by using MOX1-activity loggers (objective 1), the Vestibular Activities Avoidance Inventory (objective 2), video Head Impulse Testing including the Perez & Rey score (objective 3), Subjective Visual Vertical test and Rod & Disc test (objective 4). Measurements will be taken in the acute phase and 4, 10, 26 and 52 weeks after the acute event.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04979598 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Universiteit Antwerpen |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | Belgium |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Acute Unilateral Vestibular Deafferentiation |
Contact a Trial Team
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