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

Alzheimer Disease Clinical Trial

— GECkO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04385225
• Other study ID #: B300201938949
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: November 2022

Study information

• Verified date: May 2020
• Source: University Hospital, Antwerp
• Contact: Vincent Van Rompaey, Professor
• Phone: +32 3821 4244
• Email: nko[@]uza.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Mini Mental State Examination > 12

• Dutch-speaking

Exclusion Criteria:

• Uncorrectable visual impairment

• Hearing implants

• Hearing aids

Related Conditions & MeSH terms

• Alzheimer Disease
• Bilateral Vestibulopathy
• Cognitive Dysfunction
• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Mild Cognitive Impairment

Intervention

Other:
• Longitudinal follow-up
Longitudinal hearing, vestibular and cognitive follow-up

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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