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

Primary Purpose

Hearing Loss, Sensorineural, Bilateral Vestibulopathy, Alzheimer Disease

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Longitudinal follow-up
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hearing Loss, Sensorineural

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Mini Mental State Examination > 12
  • Dutch-speaking

Exclusion Criteria:

  • Uncorrectable visual impairment
  • Hearing implants
  • Hearing aids

Sites / Locations

  • University Hospital AntwerpRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Other

Other

Other

Other

Arm Label

Healthy controls

Moderate Sensorineural hearing loss

Severe Sensorineural hearing loss

Bilateral Vestibulopathy

Mild Cognitive Impairment

Alzheimer's Disease

Arm Description

Age-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: 41-60 decibel in the better hearing ear

Severe Sensorineural hearing loss: 61-80 decibel in the better hearing ear

Bilateral vestibulopathy: half with normal hearing, half with severe to profound sensorineural hearing loss

Mild Cognitive Impairment

Alzheimer's Disease

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 3, 2020
Last Updated
May 11, 2020
Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen
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1. Study Identification

Unique Protocol Identification Number
NCT04385225
Brief Title
Effect of Hearing Loss and Vestibular Decline on Cognitive Function in Older Subjects
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural, Bilateral Vestibulopathy, Alzheimer Disease, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy controls
Arm Type
Other
Arm Description
Age-matched controls with normal hearing or mild sensorineural hearing loss: 40 decibel or less in better hearing ear, and normal vestibular function
Arm Title
Moderate Sensorineural hearing loss
Arm Type
Other
Arm Description
Moderate Sensorineural hearing loss: 41-60 decibel in the better hearing ear
Arm Title
Severe Sensorineural hearing loss
Arm Type
Other
Arm Description
Severe Sensorineural hearing loss: 61-80 decibel in the better hearing ear
Arm Title
Bilateral Vestibulopathy
Arm Type
Other
Arm Description
Bilateral vestibulopathy: half with normal hearing, half with severe to profound sensorineural hearing loss
Arm Title
Mild Cognitive Impairment
Arm Type
Other
Arm Description
Mild Cognitive Impairment
Arm Title
Alzheimer's Disease
Arm Type
Other
Arm Description
Alzheimer's Disease
Intervention Type
Other
Intervention Name(s)
Longitudinal follow-up
Intervention Description
Longitudinal hearing, vestibular and cognitive follow-up
Primary Outcome Measure Information:
Title
Change in Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals total score
Description
Cognitive test adapted for hearing impaired subjects, minimum score is 200, maximum score is 800, higher scores indicate better cognitive performance
Time Frame
Longitudinal follow-up for 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Mini Mental State Examination > 12 Dutch-speaking Exclusion Criteria: Uncorrectable visual impairment Hearing implants Hearing aids
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Van Rompaey, Professor
Phone
+32 3821 4244
Email
nko@uza.be
Facility Information:
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Van Rompaey, professor
Phone
+32 3821 4244
Email
nko@uza.be

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32948575
Citation
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.
Results Reference
derived

Learn more about this trial

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

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