Hearing Loss, Vestibular Loss and Cognitive Performance

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

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.

Study Overview

• Status: Unknown
• Conditions: Vestibular Disorder
• Intervention / Treatment: Behavioral: RBANS-H, virtual Morris Water Maze

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Bieke Dobbels, MD; Phone Number: 0032 3 821 34 51; Email: biekedobbels@gmail.com

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital
      • Contact: Paul Van de Heyning, MD, PhD
      • Principal Investigator: Vincent Van Rompaey, MD, PhD
      • Sub-Investigator: Griet Mertens, Ausc, PhD
      • Sub-Investigator: Julie Moyaert, Ausc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with bilateral vestibulopathy, which was confirmed by vestibular testing, were enrolled in the patient group. Healthy controls with normal hearing and vestibular system were used to compare cognitive outcome measures with. Correction were made for age, sex, education and computer usage.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bilateral vestibulopathy; Patients with bilateral vestibulopathy, according to the Barany Criteria (2017, Strupp).	Behavioral: RBANS-H, virtual Morris Water Maze; Cognitive tasks for respectively: general cognition and spatial cognition
Healthy controls; Subjects without vestibular or neurological diseases (DHI<5), and with normal hearing thresholds according to their age.	Behavioral: RBANS-H, virtual Morris Water Maze; Cognitive tasks for respectively: general cognition and spatial cognition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp

Publications and helpful links

General Publications

• Peetermans O, Dobbels B, Mertens G, Moyaert J, van de Berg R, Vanderveken O, Van de Heyning P, Perez Fornos A, Guinand N, Lammers MJW, Van Rompaey V. Sound localization in patients with bilateral vestibulopathy. Eur Arch Otorhinolaryngol. 2022 Dec;279(12):5601-5613. doi: 10.1007/s00405-022-07414-7. Epub 2022 May 10.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 1, 2018
• Last Update Submitted That Met QC Criteria: September 28, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Vestibular Diseases; Hearing Loss
• Other Study ID Numbers: 16/42/426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No