Skip to content

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

Effect of Hearing Loss and Vestibular Decline on Cognitive Function in Older Subjects: Correlation With Cortical Auditory Evoked Potentials and MRI Brain Volume Changes

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04385225
Acronym
GECkO
Enrollment
300
Registered
2020-05-12
Start date
2019-12-16
Completion date
2022-11-30
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Bilateral Vestibulopathy, Hearing Loss, Sensorineural, Mild Cognitive Impairment

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.

Interventions

OTHERLongitudinal follow-up

Longitudinal hearing, vestibular and cognitive follow-up

Sponsors

Universiteit Antwerpen
CollaboratorOTHER
University Hospital, Antwerp
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Mini Mental State Examination \> 12 * Dutch-speaking

Exclusion criteria

* Uncorrectable visual impairment * Hearing implants * Hearing aids

Design outcomes

Primary

MeasureTime frameDescription
Change in Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals total scoreLongitudinal follow-up for 24 monthsCognitive test adapted for hearing impaired subjects, minimum score is 200, maximum score is 800, higher scores indicate better cognitive performance

Countries

Belgium

Contacts

Primary ContactVincent Van Rompaey, Professor
nko@uza.be+32 3821 4244

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026