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Effect of Hearing Loss and Vestibular Decline on Cognitive Function in Older Subjects (GECkO)

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ClinicalTrials.gov Identifier: NCT04385225
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Ethisch Comité, UZA, University Hospital, Antwerp

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.


Condition or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Bilateral Vestibulopathy Alzheimer Disease Mild Cognitive Impairment Other: Longitudinal follow-up Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Hearing Loss and Vestibular Decline on Cognitive Function in Older Subjects: Correlation With Cortical Auditory Evoked Potentials and MRI Brain Volume Changes
Actual Study Start Date : December 16, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022


Arm Intervention/treatment
Healthy controls
Age-matched controls with normal hearing or mild sensorineural hearing loss: 40 decibel or less in better hearing ear, and normal vestibular function
Other: Longitudinal follow-up
Longitudinal hearing, vestibular and cognitive follow-up

Moderate Sensorineural hearing loss
Moderate Sensorineural hearing loss: 41-60 decibel in the better hearing ear
Other: Longitudinal follow-up
Longitudinal hearing, vestibular and cognitive follow-up

Severe Sensorineural hearing loss
Severe Sensorineural hearing loss: 61-80 decibel in the better hearing ear
Other: Longitudinal follow-up
Longitudinal hearing, vestibular and cognitive follow-up

Bilateral Vestibulopathy
Bilateral vestibulopathy: half with normal hearing, half with severe to profound sensorineural hearing loss
Other: Longitudinal follow-up
Longitudinal hearing, vestibular and cognitive follow-up

Mild Cognitive Impairment
Mild Cognitive Impairment
Other: Longitudinal follow-up
Longitudinal hearing, vestibular and cognitive follow-up

Alzheimer's Disease
Alzheimer's Disease
Other: Longitudinal follow-up
Longitudinal hearing, vestibular and cognitive follow-up




Primary Outcome Measures :
  1. Change in Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals total score [ Time Frame: Longitudinal follow-up for 24 months ]
    Cognitive test adapted for hearing impaired subjects, minimum score is 200, maximum score is 800, higher scores indicate better cognitive performance



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mini Mental State Examination > 12
  • Dutch-speaking

Exclusion Criteria:

  • Uncorrectable visual impairment
  • Hearing implants
  • Hearing aids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385225


Contacts
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Contact: Vincent Van Rompaey, Professor +32 3821 4244 nko@uza.be

Locations
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Belgium
University Hospital Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Vincent Van Rompaey, professor    +32 3821 4244    nko@uza.be   
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ethisch Comité, UZA, Prof. dr. Vincent Van Rompaey, principal investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT04385225    
Other Study ID Numbers: B300201938949
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Bilateral Vestibulopathy
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Vestibular Diseases
Labyrinth Diseases