Effect of Hearing Loss and Vestibular Decline on Cognitive Function in Older Subjects
GECkO
1 other identifier
interventional
300
1 country
1
Brief Summary
The world population has been growing and aging dramatically, with a rising prevalence of dementia. Worldwide, around 50 million people have dementia, with 10 million new cases added every year. Despite the epidemic scale of dementia, until now no cure or disease-modifying therapy has been identified. Therefore, the World Health Organization (WHO) has recognized dementia as a public health priority. Several large studies have demonstrated that hearing impairment is associated with a greater risk of cognitive impairment. Hearing rehabilitation could potentially provide a disease-modifying therapy to delay cognitive decline. Although auditory behavioral research has not yet revealed a reliable indicator of early cognitive impairment, cortical-evoked auditory potentials (CAEP) have shown promising evidence as a non-invasive way to identify early-stage cognitive impairment. The peripheral vestibular apparatus is located in the inner ear and codes rotation and translation of the head to preserve a stable view. Increasing evidence suggests that bilateral vestibular function loss, also known as bilateral vestibulopathy (BVP), leads to hippocampal atrophy and reduced spatial cognitive skills, as well as structural and functional alterations in parieto-insular and parieto-temporal regions. Many studies have demonstrated that vestibular function declines with age. Vestibular dysfunction can be linked to reduced topographical orientation and memory and has been suggested as a risk factor to AD, due to increased risk of falling and deficits in activities of daily life (ADL). Our first aim is to study the effect of SNHL and vestibular decline on CAEP, spatial and non-spatial cognitive functioning and trajectories in cognitively healthy older subjects, as well as patients with mild cognitive impairment (MCI) and AD. Our second aim is to study if MRI brain volume changes can be observed in the hippocampus, entorhinal cortex, and auditory and vestibular key regions in these populations and correlate with CAEP and cognitive functioning. The expected outcome is important to society because it will provide data from a cognitive assessment protocol adapted for a potentially hearing-impaired population, objective outcome measures (incl. CAEP and MRI brain volume changes) to identify older subjects with SNHL and BVP at risk for cognitive decline, and will support screening and interventional studies to assess the impact of rehabilitation on slowing down cognitive decline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 16, 2019
CompletedFirst Submitted
Initial submission to the registry
February 3, 2020
CompletedFirst Posted
Study publicly available on registry
May 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedMay 12, 2020
May 1, 2020
2.9 years
February 3, 2020
May 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals total score
Cognitive test adapted for hearing impaired subjects, minimum score is 200, maximum score is 800, higher scores indicate better cognitive performance
Longitudinal follow-up for 24 months
Study Arms (6)
Healthy controls
OTHERAge-matched controls with normal hearing or mild sensorineural hearing loss: 40 decibel or less in better hearing ear, and normal vestibular function
Moderate Sensorineural hearing loss
OTHERModerate Sensorineural hearing loss: 41-60 decibel in the better hearing ear
Severe Sensorineural hearing loss
OTHERSevere Sensorineural hearing loss: 61-80 decibel in the better hearing ear
Bilateral Vestibulopathy
OTHERBilateral vestibulopathy: half with normal hearing, half with severe to profound sensorineural hearing loss
Mild Cognitive Impairment
OTHERMild Cognitive Impairment
Alzheimer's Disease
OTHERAlzheimer's Disease
Interventions
Longitudinal hearing, vestibular and cognitive follow-up
Eligibility Criteria
You may qualify if:
- Mini Mental State Examination \> 12
- Dutch-speaking
You may not qualify if:
- Uncorrectable visual impairment
- Hearing implants
- Hearing aids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Antwerplead
- Universiteit Antwerpencollaborator
Study Sites (1)
University Hospital Antwerp
Edegem, Antwerp, 2650, Belgium
Related Publications (1)
Bosmans J, Jorissen C, Cras P, Van Ombergen A, Engelborghs S, Gilles A, Princen E, Moyaert J, Mertens G, Van Rompaey V. Impact of hearing loss and vestibular decline on cognition in Alzheimer's disease: a prospective longitudinal study protocol (Gehoor, Evenwicht en Cognitie, GECkO). BMJ Open. 2020 Sep 17;10(9):e039601. doi: 10.1136/bmjopen-2020-039601.
PMID: 32948575DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr. Vincent Van Rompaey, principal investigator
Study Record Dates
First Submitted
February 3, 2020
First Posted
May 12, 2020
Study Start
December 16, 2019
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
May 12, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share