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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- RBANS-H total score
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Best aided speech audiometry in noise: Speech reception threshold (SRT)(Change from baseline best aided SRT at 6 months)
- Nijmegen Cochlear Implant Questionnaire (NCIQ)(Change from baseline NCIQ score at 6 months)
- RBANS-H index scores(Change from baseline RBANS-H index scores at 6 months)
- Hearing thresholds: best aided Fletcher Index (FI)(Change from baseline best aided FI at 6 months)
- Speech audiometry in quiet (phoneme score): score at 65 dB SPL(Change from baseline score at 65 dB SPL at 6 months)
- Speech, Spatial and Qualities of Hearing scale 12 (SSQ12)(Change from baseline SSQ12 score at 6 months)
- Hospital Anxiety and Depression Scale (HADS)(Change from baseline HADS score at 6 months)
- Hearing Implant Sound Quality Index 19 (HISQUI19)(Change from baseline HISQUI19 score at 6 months)
Investigators
Ethisch Comité UZA
Ethics Committee
University Hospital, Antwerp