Hearing Loss, Vestibular Loss and Cognitive Performance

Vestibular Disorder Clinical Trial

Official title:

The Link Between Hearing Loss, Vestibular Loss and Cognitive Performance: Cross-sectional Data in Patients With Bilateral Vestibulopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03690817
• Other study ID #: 16/42/426
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Hearing Loss
• Vestibular Diseases
• Vestibular Disorder

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