NCT02794350

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 10, 2016

Status Verified

June 1, 2016

Enrollment Period

2.2 years

First QC Date

May 30, 2016

Last Update Submit

June 9, 2016

Conditions

Hearing Impaired

Keywords

RBANS-HCochlear implantationCognitionOlder adultsRBANS

Outcome Measures

Primary Outcomes (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.

    Change from baseline RBANS-H total score at 6 months

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

Cohort

Device: Cochlear implant

Interventions

Cochlear implantDEVICE
Cohort

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 55 or older with a severe to profound hearing loss followed-up in a tertiary referral center

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35970164DERIVED

  • 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.

    PMID: 27895549DERIVED

MeSH Terms

Conditions

Hearing Loss

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural ProsthesesImplantable NeurostimulatorsElectrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and ImplantsHearing AidsSensory Aids

Central Study Contacts

Paul Van de Heyning, Prof. dr.

CONTACT

0032 3 821 47 90paul.van.de.heyning@uza.be

Annes Claes, MSc

CONTACT

0032 3 821 58 38annes.claes@uza.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ethics Committee

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 9, 2016

Study Start

July 1, 2015

Primary Completion

September 1, 2017

Study Completion

December 1, 2025

Last Updated

June 10, 2016

Record last verified: 2016-06

Locations

BE(1)