Vestibular DisorderNCT03690817
Hearing Loss, Vestibular Loss and Cognitive Performance
An observational study of Vestibular Disorder, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Hearing loss is an established independent risk factor for dementia. Likewise, recent research demonstrated cognitive deficits in subjects with vestibular loss. However, in these studies data have not been adjusted for the hearing status of the enrolled study subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- RBANS-H, virtual Morris Water Maze
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2017to 1 Jul 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with bilateral vestibulopathy, which was confirmed by vestibular testing, were enrolled in the patient group. Healthy controls with normal hearing and vestibular system were used to compare cognitive outcome measures with. Correction were made for age, sex, education and computer usage.
Who may be able to join
- Bilaterally reduced vestibular function, as defined by the Bárány Criteria for BVP (Michael Strupp 2017):
- horizontal angular VOR gain < 0.6 measured by the vHIT, and/or
- reduced caloric response (sum of bithermal, 30° and 44°, max. peak slow phase velocity (SPV) on each side < 6°/sec), and/or
- reduced horizontal angular VOR gain < 0.1 upon sinusoidal stimulation on a rotatory chair. At our clinic rotatory chair tests are performed using sinusoidal rotation (0.05 Hertz) with a peak velocity of 60°/sec (Van der Stappen A 2000).
- Disease duration of BVP > 6 months.
- Healthy controls (HC). Only subjects with no history of vertigo, scores <5 on the Dizziness Handicap Inventory (DHI) and normal hearing thresholds at 0.25 - 8 kHz, based on age and sex (defined by the BS 6951:1988, EN 27029:1991 and ISO 7029-1984 standards), were enrolled in the study.
- For both BVP patients and HC the following additional inclusion criteria were applied: 1) Age ≥ 18 years; 2) Fluency in Dutch; 3) No history of neurological diseases (e.g. dementia, Parkinson's disease, cerebrovascular accident, etc.); 4) Absence of clinical signs indicating dementia or mild cognitive impairment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Edegem, Antwerp, 2650
Paul Van de Heyning, MD, PhD
Vincent Van Rompaey, MD, PhD
About this study
Official title: The Link Between Hearing Loss, Vestibular Loss and Cognitive Performance: Cross-sectional Data in Patients With Bilateral Vestibulopathy
Hearing loss is an established independent risk factor for dementia. Likewise, recent research demonstrated cognitive deficits in subjects with vestibular loss. However, in these studies data have not been adjusted for the hearing status of the enrolled study subjects. As hearing loss prevalence is high in patients with vestibular loss, this could be a major confounder. Therefore, in this study the investigators investigate cognition in patients with bilateral vestibulopathy with and without hearing loss. The investigators adjust data for the hearing status of the patients to explore the link between hearing loss, vestibular loss and cognition.
- Conditions
- Vestibular Disorder
- Being tested
- RBANS-H, virtual Morris Water Maze
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBANS-H, virtual Morris Water MazeBehavioural
Cognitive tasks for respectively: general cognition and spatial cognition
| Study group | Role | What they receive |
|---|---|---|
| Bilateral vestibulopathy | Patients with bilateral vestibulopathy, according to the Barany Criteria (2017, Strupp). Receives: Behavioral: RBANS-H, virtual Morris Water Maze | |
| Healthy controls | Subjects without vestibular or neurological diseases (DHI<5), and with normal hearing thresholds according to their age. Receives: Behavioral: RBANS-H, virtual Morris Water Maze |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H): total score
General cognitive assessment, cfr. Claes et al 2016. The total-score is standardized with a mean of 100 and a standard deviation of 15. The higher the total score, the better the cognition of the participant.
Measured: 2 years
Virtual Morris Water Maze performance
Spatial cognition assessment, cfr. Hamilton. Path length and latency are recorded, the higher the worse the spatial cognition of the participant.
Measured: 2 years
Secondary outcomes (1)
The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H): index scores
Cfr. Claes et al 2016. The subscale are standardized with a mean of 100 and standard deviation of 15. The higher the score, the better the performance on a specific subdomain of cognition (attention, immediate memory, delayed memory, visuospatial and language)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Sep 2017
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethisch Comité, UZA, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690817
- Sponsor's protocol ID
- 16/42/426
- Status last verified
- Sep 2018
- First submitted
- 27 Aug 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peetermans O, Dobbels B, Mertens G, Moyaert J, van de Berg R, Vanderveken O, Van de Heyning P, Perez Fornos A, Guinand N, Lammers MJW, Van Rompaey V. Sound localization in patients with bilateral vestibulopathy. Eur Arch Otorhinolaryngol. 2022 Dec;279(12):5601-5613. doi: 10.1007/s00405-022-07414-7. Epub 2022 May 10.
PubMed 35536383
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Link Between Hearing Loss, Vestibular Loss and Cognitive Performance: Cross-sectional Data in Patients With Bilateral Vestibulopathy
- ClinicalTrials.gov ID
- NCT03690817
- Acronym / sponsor ID
- 16/42/426
- Conditions
- Vestibular Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 1 Oct 2018 (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.
Hearing loss is an established independent risk factor for dementia. Likewise, recent research demonstrated cognitive deficits in subjects with vestibular loss. However, in these studies data have not been adjusted for the hearing status of the enrolled study subjects. As hearing loss prevalence is high in patients with vestibular loss, this could be a major confounder. Therefore, in this study the investigators investigate cognition in patients with bilateral vestibulopathy with and without hearing loss. The investigators adjust data for the hearing status of the patients to explore the link between hearing loss, vestibular loss and cognition.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral vestibulopathy | – | Behavioral: RBANS-H, virtual Morris Water MazePatients with bilateral vestibulopathy, according to the Barany Criteria (2017, Strupp). |
| Healthy controls | – | Behavioral: RBANS-H, virtual Morris Water MazeSubjects without vestibular or neurological diseases (DHI<5), and with normal hearing thresholds according to their age. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bilateral vestibulopathy, which was confirmed by vestibular testing, were enrolled in the patient group. Healthy controls with normal hearing and vestibular system were used to compare cognitive outcome measures with. Correction were made for age, sex, education and computer usage.
Key inclusion criteria (7 listed)
- Bilaterally reduced vestibular function, as defined by the Bárány Criteria for BVP (Michael Strupp 2017):
- Disease duration of BVP > 6 months.
- Healthy controls (HC). Only subjects with no history of vertigo, scores <5 on the Dizziness Handicap Inventory (DHI) and normal hearing thresholds at 0.25 - 8 kHz, based on age and sex (defined by the BS 6951:1988, EN 27029:1991 and ISO 7029-1984 standards), were enrolled in the study.
- For both BVP patients and HC the following additional inclusion criteria were applied: 1) Age ≥ 18 years; 2) Fluency in Dutch; 3) No history of neurological diseases (e.g. dementia, Parkinson's disease, cerebrovascular accident, etc.); 4) Absence of clinical signs indicating dementia or mild cognitive impairment.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| RBANS-H, virtual Morris Water MazeCognitive tasks for respectively: general cognition and spatial cognition | Behavioural | Bilateral vestibulopathy, Healthy controls |
Primary outcome
The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H): total score
Time frame: 2 years
General cognitive assessment, cfr. Claes et al 2016. The total-score is standardized with a mean of 100 and a standard deviation of 15. The higher the total score, the better the cognition of the participant.
Virtual Morris Water Maze performance
Time frame: 2 years
Spatial cognition assessment, cfr. Hamilton. Path length and latency are recorded, the higher the worse the spatial cognition of the participant.
1 secondary outcome
The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H): index scores
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Derived from this study: PubMed 35536383Peetermans O, Dobbels B, Mertens G, Moyaert J, van de Berg R, Vanderveken O, Van de Heyning P, Perez Fornos A, Guinand N, Lammers MJW, Van Rompaey V. Sound localization in patients with bilateral vestibulopathy. Eur Arch Otorhinolaryngol. 2022 Dec;279(12):5601-5613. doi: 10.1007/s00405-022-07414-7. Epub 2022 May 10.
- 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?
An observational study of Vestibular Disorder, 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 7 inclusion and 0 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 1 Oct 2018. 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 Bieke Dobbels, MD (0032 3 821 34 51, biekedobbels@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H): total score (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT03690817, which also lists 1 linked publication.
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 1 Oct 2018.