NCT03690817

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

August 27, 2018

Last Update Submit

September 28, 2018

Conditions

Vestibular Disorder

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H): index scores

    2 years

Study Arms (2)

Bilateral vestibulopathy

Patients with bilateral vestibulopathy, according to the Barany Criteria (2017, Strupp).

Behavioral: RBANS-H, virtual Morris Water Maze

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

Interventions

RBANS-H, virtual Morris Water MazeBEHAVIORAL

Cognitive tasks for respectively: general cognition and spatial cognition

Bilateral vestibulopathyHealthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35536383DERIVED

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Bieke Dobbels, MD

CONTACT

0032 3 821 34 51biekedobbels@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2018

First Posted

October 1, 2018

Study Start

September 1, 2017

Primary Completion

January 1, 2019

Study Completion

July 1, 2019

Last Updated

October 1, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)