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

A

Antwerp University Hospital (UZA)

Status

Unknown

Conditions

Alzheimer Disease
Mild Cognitive Impairment
Bilateral Vestibulopathy
Hearing Loss, Sensorineural

Treatments

Other: Longitudinal follow-up

Study type

Interventional

Funder types

Other

Identifiers

NCT04385225
B300201938949

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Mini Mental State Examination > 12
  • Dutch-speaking

Exclusion criteria

  • Uncorrectable visual impairment
  • Hearing implants
  • Hearing aids

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 6 patient groups

Healthy controls
Other group
Description:
Age-matched controls with normal hearing or mild sensorineural hearing loss: 40 decibel or less in better hearing ear, and normal vestibular function
Treatment:
Other: Longitudinal follow-up
Moderate Sensorineural hearing loss
Other group
Description:
Moderate Sensorineural hearing loss: 41-60 decibel in the better hearing ear
Treatment:
Other: Longitudinal follow-up
Severe Sensorineural hearing loss
Other group
Description:
Severe Sensorineural hearing loss: 61-80 decibel in the better hearing ear
Treatment:
Other: Longitudinal follow-up
Bilateral Vestibulopathy
Other group
Description:
Bilateral vestibulopathy: half with normal hearing, half with severe to profound sensorineural hearing loss
Treatment:
Other: Longitudinal follow-up
Mild Cognitive Impairment
Other group
Description:
Mild Cognitive Impairment
Treatment:
Other: Longitudinal follow-up
Alzheimer's Disease
Other group
Description:
Alzheimer's Disease
Treatment:
Other: Longitudinal follow-up

Trial contacts and locations

1

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Central trial contact

Vincent Van Rompaey, Professor

Data sourced from clinicaltrials.gov

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