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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Paul Van de Heyning, Prof. dr. contact

0032 3 821 47 90

paul.van.de.heyning@uza.be

Annes Claes, MSc contact

0032 3 821 58 38

annes.claes@uza.be

Belgium1 site, 1 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

    Recruiting

Other trials in Belgium

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.

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 groups in NCT02794350
Study groupRoleWhat they receive
CohortNot described
Receives: Device: Cochlear implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted9 Jun 2016 (estimated)
  2. Study startJul 2015
  3. Primary completionSep 2017 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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)
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 35970164
  • Claes 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

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.

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