Normal HearingRBANS-H_ARHLNCT03208608
The RBANS-H in Older Adults With Normal Hearing or Age-related Hearing Loss
An observational study of Normal Hearing, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The present cross-sectional study aims to examine the cognitive capabilities of older adults, aged 50 to 89, with normal hearing or age-related hearing loss by means of the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing impaired individuals (RBANS-H). Read more about this study
- Who is it for?
- Ages 50 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Hearing
- What is being tested?
- RBANS-H
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Nov 2016to Oct 2017
- 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 50 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 50 to 89 with hearing thresholds according to their age and without history of any neurological or otological diseases
Who may be able to join
- Hearing: Air conduction hearing thresholds according to age, based on the ISO standards
- Age: 50 - 89
Who cannot join
- History of any neurological disease
- History of otological surgery or disease
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Edegem, Antwerp, 2650
Paul Van de Heyning, prof PhD MD, 0032 3 821 47 30, paul.van.de.heyning@uza.be
Annes Claes, MSc, 0032 3 821 58 38, annes.claes@uza.be
About this study
Official title: The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H) in Older Adults With Normal Hearing or Age-related Hearing Loss
The present cross-sectional study aims to examine the cognitive capabilities of older adults, aged 50 to 89, with normal hearing or age-related hearing loss by means of the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing impaired individuals (RBANS-H). Secondly, the correlations between cognition on the one hand and hearing and speech reception capabilities on the other hand are investigated. For this purpose, twenty participants are included in the age categories 50 to 59, 60 to 69, 70 to 79 and 80 to 89, bringing the total number to 80. Three questionnaires are administered to the participants: the Health Utilities Index-2/3 (HUI 2/3), Dizziness Handicap Inventory (DHI) and a general questionnaire on education and profession, medical history, hearing aid use and tinnitus. Also an audiological examination is performed, including pure tone audiometry, speech in quiet and speech in noise audiometry. Finally, cognition is assessed using the RBANS-H.
- Conditions
- Normal Hearing
- Being tested
- RBANS-H
- Keywords
- RBANS-H, Older adults, Normal hearing, Cognition, Age-related hearing loss
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBANS-HDiagnostic test
The RBANS-H is a diagnostic cognitive test battery
| Study group | Role | What they receive |
|---|---|---|
| Normal hearing older adults | Older adults with normal hearing or age-related hearing loss Receives: Diagnostic Test: RBANS-H |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBANS-H total scaled score
The RBANS-H assess cognition and provides one total score of cognition.
Measured: Baseline
Secondary outcomes (7)
RBANS-H index scores
The RBANS-H assesses five cognitive domains (Immediate Memory, Visuospatial/constructional, Language, Attention and Delayed Memory). The test consists of twelve subtests and the score on each subtest contributes to one of the five domains.
Measured: Baseline
Free field best aided speech in noise audiometry: Speech Reception Threshold (SRT)
The speech reception in noise is assessed by means of the Leuven Intelligibility Sentences Test (LIST) using an adaptive procedure. This speech material is developed to quantify the speech understanding in subjects with severely impaired hearing. The frequency spectrum of the noise signal is equal to the long-term average speech spectrum of the sentences. The level of the noise is fixed at 65 dB SPL, while the level of the speech signal is altered depending on the response of the patient. Each list consists of ten sentences and the speech reception threshold (SRT) is calculated as the mean level of the last five sentences together with the level of the imaginary 11th sentence of the list. This speech in noise test is performed both pre- and postoperatively in an aided, free field situation with the loudspeaker in front of the subject at a distance of one meter.
Measured: Baseline
Free field best aided speech in quiet audiometry (phoneme score): SRT
Speech reception in quiet is measured using Dutch open-set word lists. Each list consists of twelve monosyllabic words (consonant-vowel-consonant) of which one is a training item. The lists are presented at 65, 55, 40, 30, 20 and 10 dB SPL in free field with a loudspeaker at 0° azimuth. The intensity at which 50% of the phonemes is received correctly, is the SRT.
Measured: Baseline
Free field best aided hearing thresholds: Fletcher Index (FI)
The best aided thresholds with no, one or two hearing aid(s) are measured through free field audiometry with warble tones. The loudspeaker is placed at a distance of one meter in front of the subject at ear level.
Measured: Baseline
Health Utilities Index-2/3 (HUI 2/3)
The HUI questionnaire measures the self-perceived health status of the participant and rates the health-related quality of life (HRQL). The questionnaire consists of 17 items with four to six options. The HRQL scoring systems provide utility (preference) scores on a generic scale where dead = 0.00 and perfect health = 1.00.
Measured: Baseline
Dizziness Handicap Inventory (DHI)
The DHI is used to quantify the impact of dizziness on everyday life. This 25-item questionnaire was developed to assess the self-perceived handicapping effects imposed by vestibular system disorders. Each item is rated as Yes = 4, Sometimes = 2 or No = 0 and contributes to one of three subscales, namely Functional, Emotional and Physical. A total score is calculated adding the scores on each item.
Measured: Baseline
General questionnaire
A non-validated general questionnaire on education and profession, medical history, hearing aid use and tinnitus
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start21 Nov 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal HearingStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 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
- Investigators
- Paul Van de Heyning, prof PhD MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208608
- Sponsor's protocol ID
- 16/43/450
- Acronym
- RBANS-H_ARHL
- Status last verified
- Jul 2017
- First submitted
- 23 Jun 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H) in Older Adults With Normal Hearing or Age-related Hearing Loss
- ClinicalTrials.gov ID
- NCT03208608
- Acronym / sponsor ID
- RBANS-H_ARHL / 16/43/450
- Conditions
- Normal Hearing
- Keywords
- RBANS-H, Older adults, Normal hearing, Cognition, Age-related hearing loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 5 Jul 2017 (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 present cross-sectional study aims to examine the cognitive capabilities of older adults, aged 50 to 89, with normal hearing or age-related hearing loss by means of the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing impaired individuals (RBANS-H). Secondly, the correlations between cognition on the one hand and hearing and speech reception capabilities on the other hand are investigated. For this purpose, twenty participants are included in the age categories 50 to 59, 60 to 69, 70 to 79 and 80 to 89, bringing the total number to 80. Three questionnaires are administered to the participants: the Health Utilities Index-2/3 (HUI 2/3), Dizziness Handicap Inventory (DHI) and a general questionnaire on education and profession, medical history, hearing aid use and tinnitus. Also an audiological examination is performed, including pure tone audiometry, speech in quiet and speech in noise audiometry. Finally, cognition is assessed using the RBANS-H.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal hearing older adults | – | Diagnostic Test: RBANS-HOlder adults with normal hearing or age-related hearing loss |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 50 to 89 with hearing thresholds according to their age and without history of any neurological or otological diseases
Key inclusion criteria (2 listed)
- Hearing: Air conduction hearing thresholds according to age, based on the ISO standards
- Age: 50 - 89
Key exclusion criteria (2 listed)
- History of any neurological disease
- History of otological surgery or disease
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-HThe RBANS-H is a diagnostic cognitive test battery | Diagnostic test | Normal hearing older adults |
Primary outcome
RBANS-H total scaled score
Time frame: Baseline
The RBANS-H assess cognition and provides one total score of cognition.
7 secondary outcomes
RBANS-H index scores
Time frame: Baseline
Free field best aided speech in noise audiometry: Speech Reception Threshold (SRT)
Time frame: Baseline
Free field best aided speech in quiet audiometry (phoneme score): SRT
Time frame: Baseline
Free field best aided hearing thresholds: Fletcher Index (FI)
Time frame: Baseline
Health Utilities Index-2/3 (HUI 2/3)
Time frame: Baseline
Dizziness Handicap Inventory (DHI)
Time frame: Baseline
General questionnaire
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
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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.
Paul Van de Heyning, prof PhD MD principal investigator
University Hospital, Antwerp
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 Normal Hearing, 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 2 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 5 Jul 2017. 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 Paul Van de Heyning, prof PhD MD (0032 3 821 47 30, paul.van.de.heyning@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RBANS-H total scaled score (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2017.