Hearing Loss, Vestibular Loss and Cognitive Performance

• Conditions: Vestibular Disorder
• Interventions: Behavioral: RBANS-H, virtual Morris Water Maze

• Registration Number: NCT03690817
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

Hearing loss is an established independent risk factor for dementia. Likewise, recent research demonstrated cognitive deficits in subjects with vestibular loss. However, in these studies data have not been adjusted for the hearing status of the enrolled study subjects. As hearing loss prevalence is high in patients with vestibular loss, this could be a major confounder. Therefore, in this study the investigators investigate cognition in patients with bilateral vestibulopathy with and without hearing loss. The investigators adjust data for the hearing status of the patients to explore the link between hearing loss, vestibular loss and cognition.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-08-27
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-28
• Last Update Submitted: 2018-09-28
• Study First Posted: 2018-10-01
• Last Update Posted: 2018-10-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bilateral vestibulopathy	RBANS-H, virtual Morris Water Maze	Patients with bilateral vestibulopathy, according to the Barany Criteria (2017, Strupp).
Healthy controls	RBANS-H, virtual Morris Water Maze	Subjects without vestibular or neurological diseases (DHI\<5), and with normal hearing thresholds according to their age.

Primary Outcome Measures

Name	Time	Method
The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H): total score	2 years	General cognitive assessment, cfr. Claes et al 2016. The total-score is standardized with a mean of 100 and a standard deviation of 15. The higher the total score, the better the cognition of the participant.
Virtual Morris Water Maze performance	2 years	Spatial cognition assessment, cfr. Hamilton. Path length and latency are recorded, the higher the worse the spatial cognition of the participant.

Secondary Outcome Measures

Name	Time	Method
The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H): index scores	2 years	Cfr. Claes et al 2016. The subscale are standardized with a mean of 100 and standard deviation of 15. The higher the score, the better the performance on a specific subdomain of cognition (attention, immediate memory, delayed memory, visuospatial and language)

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium