Clinical trial NCT02794350: RBANS-H in Older Patients Before and After Cochlear Implantation: A Protocol for a Prospective 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Impaired
Keywords: RBANS-H
Cochlear implantation
Cognition
Older adults
RBANS
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 55 or older with a severe to profound hearing loss followed-up in a tertiary referral center

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.


Eligibility criteria: 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)

Primary outcomes:
measure: RBANS-H total score
timeFrame: Change from baseline RBANS-H total score at 6 months
Secondary outcomes:
measure: Best aided speech audiometry in noise: Speech reception threshold (SRT)
timeFrame: Change from baseline best aided SRT at 6 months
measure: Nijmegen Cochlear Implant Questionnaire (NCIQ)
timeFrame: Change from baseline NCIQ score at 6 months
measure: RBANS-H index scores
timeFrame: Change from baseline RBANS-H index scores at 6 months
measure: Hearing thresholds: best aided Fletcher Index (FI)
timeFrame: Change from baseline best aided FI at 6 months
measure: Speech audiometry in quiet (phoneme score): score at 65 dB SPL
timeFrame: Change from baseline score at 65 dB SPL at 6 months
measure: Speech, Spatial and Qualities of Hearing scale 12 (SSQ12)
timeFrame: Change from baseline SSQ12 score at 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from baseline HADS score at 6 months
measure: Hearing Implant Sound Quality Index 19 (HISQUI19)
timeFrame: Change from baseline HISQUI19 score at 6 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
citation: 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.
citation: 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.