Clinical trial NCT03690817: Hearing Loss, Vestibular Loss and Cognitive Performance
Official title: The Link Between Hearing Loss, Vestibular Loss and Cognitive Performance: Cross-sectional Data in Patients With Bilateral Vestibulopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vestibular Disorder
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H): total score
timeFrame: 2 years
measure: Virtual Morris Water Maze performance
timeFrame: 2 years
Secondary outcomes:
measure: The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H): index scores
timeFrame: 2 years
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
citation: 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.