Hearing Loss, SensorineuralGECkONCT04385225
Effect of Hearing Loss and Vestibular Decline on Cognitive Function in Older Subjects
A study testing Longitudinal follow-up in people with Hearing Loss, Sensorineural and Bilateral Vestibulopathy, run by University Hospital, Antwerp at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural, Bilateral Vestibulopathy, Alzheimer Disease
- What is being tested?
- Longitudinal follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Dec 2019to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mini Mental State Examination > 12
- Dutch-speaking
Who cannot join
- Uncorrectable visual impairment
- Hearing implants
- Hearing aids
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Antwerp
Edegem, Antwerp, 2650
Vincent Van Rompaey, professor, +32 3821 4244, nko@uza.be
About this study
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
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).
Read more
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.
- Conditions
- Hearing Loss, Sensorineural, Bilateral Vestibulopathy, Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- Longitudinal follow-up
- Medical subject headings
- Hearing Loss, Sensorineural, Bilateral Vestibulopathy, Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal follow-upOther
Longitudinal hearing, vestibular and cognitive follow-up
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Other | Age-matched controls with normal hearing or mild sensorineural hearing loss: 40 decibel or less in better hearing ear, and normal vestibular function Receives: Other: Longitudinal follow-up |
| Moderate Sensorineural hearing loss | Other | Moderate Sensorineural hearing loss: 41-60 decibel in the better hearing ear Receives: Other: Longitudinal follow-up |
| Severe Sensorineural hearing loss | Other | Severe Sensorineural hearing loss: 61-80 decibel in the better hearing ear Receives: Other: Longitudinal follow-up |
| Bilateral Vestibulopathy | Other | Bilateral vestibulopathy: half with normal hearing, half with severe to profound sensorineural hearing loss Receives: Other: Longitudinal follow-up |
| Mild Cognitive Impairment | Other | Mild Cognitive Impairment Receives: Other: Longitudinal follow-up |
| Alzheimer's Disease | Other | Alzheimer's Disease Receives: Other: Longitudinal follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Longitudinal follow-up for 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start16 Dec 2019
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Principal investigator, Ethisch Comité, UZA, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385225
- Sponsor's protocol ID
- B300201938949
- Acronym
- GECkO
- Status last verified
- May 2020
- First submitted
- 3 Feb 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bosmans J, Gommeren H, Zu Eulenburg P, Gilles A, Mertens G, Van Ombergen A, Cras P, Engelborghs S, Van Rompaey V. Is vestibular function related to human hippocampal volume? J Vestib Res. 2024;34(1):3-13. doi: 10.3233/VES-230076.
PubMed 37927291Bosmans 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.
PubMed 32948575
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04385225
- Acronym / sponsor ID
- GECkO / B300201938949
- Conditions
- Hearing Loss, Sensorineural, Bilateral Vestibulopathy, Alzheimer Disease, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Other | Other: Longitudinal follow-upAge-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 | Other | Other: Longitudinal follow-upModerate Sensorineural hearing loss: 41-60 decibel in the better hearing ear |
| Severe Sensorineural hearing loss | Other | Other: Longitudinal follow-upSevere Sensorineural hearing loss: 61-80 decibel in the better hearing ear |
| Bilateral Vestibulopathy | Other | Other: Longitudinal follow-upBilateral vestibulopathy: half with normal hearing, half with severe to profound sensorineural hearing loss |
| Mild Cognitive Impairment | Other | Other: Longitudinal follow-upMild Cognitive Impairment |
| Alzheimer's Disease | Other | Other: Longitudinal follow-upAlzheimer's Disease |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mini Mental State Examination > 12
- Dutch-speaking
Key exclusion criteria (3 listed)
- Uncorrectable visual impairment
- Hearing implants
- Hearing aids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Longitudinal follow-upLongitudinal hearing, vestibular and cognitive follow-up | Other | Alzheimer's Disease, Bilateral Vestibulopathy, Healthy controls, Mild Cognitive Impairment, Moderate Sensorineural hearing loss, Severe Sensorineural hearing loss |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 37927291Bosmans J, Gommeren H, Zu Eulenburg P, Gilles A, Mertens G, Van Ombergen A, Cras P, Engelborghs S, Van Rompaey V. Is vestibular function related to human hippocampal volume? J Vestib Res. 2024;34(1):3-13. doi: 10.3233/VES-230076.
- Derived from this study: PubMed 32948575Bosmans 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Longitudinal follow-up in people with Hearing Loss, Sensorineural and Bilateral Vestibulopathy, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Van Rompaey, Professor (+32 3821 4244, nko@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals total score (time frame: Longitudinal follow-up for 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04385225, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.