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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03690817
Other study ID # 16/42/426
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date July 1, 2019

Study information

Verified date September 2018
Source University Hospital, Antwerp
Contact Bieke Dobbels, MD
Phone 0032 3 821 34 51
Email biekedobbels@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date July 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria for BVP patients were:

1. Bilaterally reduced vestibular function, as defined by the Bárány Criteria for BVP (Michael Strupp 2017):

- horizontal angular VOR gain < 0.6 measured by the vHIT, and/or

- reduced caloric response (sum of bithermal, 30° and 44°, max. peak slow phase velocity (SPV) on each side < 6°/sec), and/or

- reduced horizontal angular VOR gain < 0.1 upon sinusoidal stimulation on a rotatory chair. At our clinic rotatory chair tests are performed using sinusoidal rotation (0.05 Hertz) with a peak velocity of 60°/sec (Van der Stappen A 2000).

2. Disease duration of BVP > 6 months.

Healthy controls (HC). Only subjects with no history of vertigo, scores <5 on the Dizziness Handicap Inventory (DHI) and normal hearing thresholds at 0.25 - 8 kHz, based on age and sex (defined by the BS 6951:1988, EN 27029:1991 and ISO 7029-1984 standards), were enrolled in the study.

For both BVP patients and HC the following additional inclusion criteria were applied: 1) Age = 18 years; 2) Fluency in Dutch; 3) No history of neurological diseases (e.g. dementia, Parkinson's disease, cerebrovascular accident, etc.); 4) Absence of clinical signs indicating dementia or mild cognitive impairment.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
RBANS-H, virtual Morris Water Maze
Cognitive tasks for respectively: general cognition and spatial cognition

Locations

Country Name City State
Belgium Antwerp University Hospital Edegem Antwerp

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H): total score 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. 2 years
Primary Virtual Morris Water Maze performance Spatial cognition assessment, cfr. Hamilton. Path length and latency are recorded, the higher the worse the spatial cognition of the participant. 2 years
Secondary The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H): index scores 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) 2 years
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