Hearing ImpairedRBANS-H-CI-ANCT02794350
RBANS-H in Older Patients Before and After Cochlear Implantation: A Protocol for a Prospective Study
An observational study of Hearing Impaired, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The cognitive profile of older adults with a severe to profound hearing impairment is determined by means of the Repeatable Battery for the Assessment of Neuropsychological Status, adjusted for Hearing impaired subjects (RBANS-H) before and after cochlear implantation. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hearing Impaired
- What is being tested?
- Cochlear implant
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2015to Dec 2025
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 55 or older with a severe to profound hearing loss followed-up in a tertiary referral center
Who may be able to join
- age: 55 or older
- cochlear implant candidate (speech understanding in quiet worse than 60% at 65 decibel sound pressure level (dB SPL) in the best aided condition)
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, Prof. dr., 0032 3 821 47 90, paul.van.de.heyning@uza.be
Annes Claes, MSc, 0032 3 821 58 38, annes.claes@uza.be
About this study
Official title: Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Subjects (RBANS-H) in Older Patients Before and After Cochlear Implantation: A Protocol for a Prospective, Longitudinal Cohort Study
The cognitive profile of older adults with a severe to profound hearing impairment is determined by means of the Repeatable Battery for the Assessment of Neuropsychological Status, adjusted for Hearing impaired subjects (RBANS-H) before and after cochlear implantation. In this prospective, longitudinal study the participants are tested preoperatively, at six months and twelve months postoperatively and from then on yearly up to 10 years after implantation. In addition to the RBANS-H an audiological examination and an semistructured interview is conducted concerning the cochlear implant use and the self-reliance of the patient and subjective questionnaires are filled out by the subjects to assess quality of life and hearing benefit.
- Conditions
- Hearing Impaired
- Being tested
- Cochlear implant
- Keywords
- RBANS-H, Cochlear implantation, Cognition, Older adults, RBANS
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantDevice
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described Receives: Device: Cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBANS-H total score
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: Change from baseline RBANS-H total score at 6 months
Secondary outcomes (8)
Best aided speech audiometry in noise: 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: Change from baseline best aided SRT at 6 months
Nijmegen Cochlear Implant Questionnaire (NCIQ)
NCIQ is a self-assessment health-related quality of life instrument developed for use in CI users. The questionnaire consists of sixty questions divided into three principal domains: Physical, Psychological and Social. The first domain comprises three subdomains, namely Basic sound perception, Advanced sound perception and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers ten statements. Each statement is rated on a 5-point Likert scale ranging from 'Never' to 'Always'.
Measured: Change from baseline NCIQ score at 6 months
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: Change from baseline RBANS-H index scores at 6 months
Hearing thresholds: best aided Fletcher Index (FI)
The best-aided thresholds with hearing aid(s) and/or cochlear implant (CI) 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: Change from baseline best aided FI at 6 months
Speech audiometry in quiet (phoneme score): score at 65 dB SPL
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. One list is presented at 65 dB SPL in free field (aided, pre- and postoperatively) with a loudspeaker at 0° azimuth. The speech recognition score is the percentage of correctly identified phonemes.
Measured: Change from baseline score at 65 dB SPL at 6 months
Speech, Spatial and Qualities of Hearing scale 12 (SSQ12)
The SSQ12 is a short form of the Speech, Spatial and Qualities of Hearing scale. It is developed for use in clinical research and rehabilitation settings to measure a range of hearing disabilities across several domains such as speech in noise, speech in speech, localization, distance and movement, segregation and listening effort. The twelve items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these twelve items.
Measured: Change from baseline SSQ12 score at 6 months
Hospital Anxiety and Depression Scale (HADS)
To detect states of depression and anxiety the Hospital Anxiety and Depression Scale (HADS) is used. This self-assessment questionnaire consists of seven items in the subscale Depression and seven items in the subscale Anxiety and distinguishes clearly between both emotional disorders.
Measured: Change from baseline HADS score at 6 months
Hearing Implant Sound Quality Index 19 (HISQUI19)
The HISQUI19 is a 19-item questionnaire to quantify the degree of self-perceived auditory benefit experienced by CI users in everyday communication situations. The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option 'not applicable' correspond to 0 in this calculation. A total score of less than 30, 30 to 59, 60 to 89, 90 to 109 and 110 to 133 is respectively classified as a very poor, poor, moderate, good and very good self-perceived auditory benefit. The validated Dutch version of the questionnaire is used.
Measured: Change from baseline HISQUI19 score at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startJul 2015
- Primary completionSep 2017 (estimated)
- Study completionDec 2025 (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 ImpairedStudies 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
- Prospective
- Enrolment
- 20 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
- NCT02794350
- Sponsor's protocol ID
- 15/17/181
- Acronym
- RBANS-H-CI-A
- Status last verified
- Jun 2016
- First submitted
- 30 May 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
Publications
Andries E, Bienkowska K, Swierniak W, Skarzynski PH, Skarzynski H, Calvino M, Cuadrado IS, Munoz E, Gavilan J, Lassaletta L, Tavora-Vieira D, Acharya A, Killan C, Ridgwell J, Raine C, Van de Heyning P, Van Rompaey V, Mertens G. Evolution of Type D Personality Traits After Cochlear Implantation in Severely Hearing Impaired Adults 55 Years and Older: An Exploratory Prospective, Longitudinal, Controlled, Multicenter Study. Otol Neurotol. 2022 Sep 1;43(8):e865-e871. doi: 10.1097/MAO.0000000000003622.
PubMed 35970164Claes AJ, Mertens G, Gilles A, Hofkens-Van den Brandt A, Fransen E, Van Rompaey V, Van de Heyning P. The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H) before and after Cochlear Implantation: A Protocol for a Prospective, Longitudinal Cohort Study. Front Neurosci. 2016 Nov 15;10:512. doi: 10.3389/fnins.2016.00512. eCollection 2016.
PubMed 27895549
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Subjects (RBANS-H) in Older Patients Before and After Cochlear Implantation: A Protocol for a Prospective, Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT02794350
- Acronym / sponsor ID
- RBANS-H-CI-A / 15/17/181
- Conditions
- Hearing Impaired
- Keywords
- RBANS-H, Cochlear implantation, Cognition, Older adults, RBANS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Jun 2016 (estimated)
- 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 cognitive profile of older adults with a severe to profound hearing impairment is determined by means of the Repeatable Battery for the Assessment of Neuropsychological Status, adjusted for Hearing impaired subjects (RBANS-H) before and after cochlear implantation. In this prospective, longitudinal study the participants are tested preoperatively, at six months and twelve months postoperatively and from then on yearly up to 10 years after implantation. In addition to the RBANS-H an audiological examination and an semistructured interview is conducted concerning the cochlear implant use and the self-reliance of the patient and subjective questionnaires are filled out by the subjects to assess quality of life and hearing benefit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Device: Cochlear implant |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 55 or older with a severe to profound hearing loss followed-up in a tertiary referral center
Key inclusion criteria (2 listed)
- age: 55 or older
- cochlear implant candidate (speech understanding in quiet worse than 60% at 65 decibel sound pressure level (dB SPL) in the best aided condition)
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 |
|---|---|---|
| Cochlear implant | Device | Cohort |
Primary outcome
RBANS-H total score
Time frame: Change from baseline RBANS-H total score at 6 months
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.
8 secondary outcomes
Best aided speech audiometry in noise: Speech reception threshold (SRT)
Time frame: Change from baseline best aided SRT at 6 months
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Time frame: Change from baseline NCIQ score at 6 months
RBANS-H index scores
Time frame: Change from baseline RBANS-H index scores at 6 months
Hearing thresholds: best aided Fletcher Index (FI)
Time frame: Change from baseline best aided FI at 6 months
Speech audiometry in quiet (phoneme score): score at 65 dB SPL
Time frame: Change from baseline score at 65 dB SPL at 6 months
Speech, Spatial and Qualities of Hearing scale 12 (SSQ12)
Time frame: Change from baseline SSQ12 score at 6 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline HADS score at 6 months
Hearing Implant Sound Quality Index 19 (HISQUI19)
Time frame: Change from baseline HISQUI19 score at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Derived from this study: PubMed 35970164Andries E, Bienkowska K, Swierniak W, Skarzynski PH, Skarzynski H, Calvino M, Cuadrado IS, Munoz E, Gavilan J, Lassaletta L, Tavora-Vieira D, Acharya A, Killan C, Ridgwell J, Raine C, Van de Heyning P, Van Rompaey V, Mertens G. Evolution of Type D Personality Traits After Cochlear Implantation in Severely Hearing Impaired Adults 55 Years and Older: An Exploratory Prospective, Longitudinal, Controlled, Multicenter Study. Otol Neurotol. 2022 Sep 1;43(8):e865-e871. doi: 10.1097/MAO.0000000000003622.
- Derived from this study: PubMed 27895549Claes AJ, Mertens G, Gilles A, Hofkens-Van den Brandt A, Fransen E, Van Rompaey V, Van de Heyning P. The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H) before and after Cochlear Implantation: A Protocol for a Prospective, Longitudinal Cohort Study. Front Neurosci. 2016 Nov 15;10:512. doi: 10.3389/fnins.2016.00512. eCollection 2016.
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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 Hearing Impaired, 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 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 10 Jun 2016. 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. dr. (0032 3 821 47 90, 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 score (time frame: Change from baseline RBANS-H total score at 6 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 NCT02794350, 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 10 Jun 2016; AzTrials last refreshed its copy on 6 Nov 2026.