Unravelling Risk Factors for Chronic Dizziness in Patients After an Acute Unilateral Vestibular Deafferentiation.

NCT04979598 | Completed DMC

• 1 other identifier: 42186
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Unilateral Vestibular Deafferentiation

Keywords

Vestibular Neuritis; Labyrinthitis; Vestibular Neurectomy; Resection Vestibular Schwannoma; Gentamicin Injection

Outcome Measures

Primary Outcomes (1)

• Dizziness Handicap Inventory

  Questionnaire concerning impairments due to dizziness: the higher the score, the bigger the perceived handicap due to dizziness.

  6 months

Secondary Outcomes (5)

• Perez-and Rey score

  Week 1, 4, 10, 26 & 52

• Mox1loggers

  Week 1 & 10

• Rod&Disc test

  Week 10 & 26

• Anxiety

  Week 1, 4, 10, 26 & 52

• Avoidance behavior

  Week 1, 4, 10, 26 & 52

Study Arms (1)

Acute unilateral vestibular deafferentiation

Patients suffering from acute dizziness due to a unilateral vestibular deafferentiation.

Other: Home exercise program

Interventions

Home exercise program OTHER

A home exercise program is provided but this is an observational study. The effect of the exercise program is not under investigation.

Acute unilateral vestibular deafferentiation

Eligibility Criteria

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

Study Population

Patients with an acute unilateral vestibular deafferentiation

You may qualify if:

• Acute unilateral vestibular deafferentiation

You may not qualify if:

• Central pathologies and bilateral vestibulopathies

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

University of Antwerp

Antwerp, Antwerpen, 2610, Belgium

Location

Related Publications (32)

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MeSH Terms

Conditions

Vestibular Neuronitis; Labyrinthitis

Condition Hierarchy (Ancestors)

Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Labyrinth Diseases; Otitis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 28, 2021
• Study Start: June 3, 2021
• Primary Completion: October 30, 2024
• Study Completion: November 1, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

BE (1)