RBANS-H in Older Patients Before and After Cochlear Implantation: A Protocol for a Prospective Study

NCT ID: NCT02794350

Last Updated: 2016-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hearing Impaired

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

Cochlear implant

Intervention Type DEVICE

Interventions

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Cochlear implant

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Ethisch Comité UZA

Ethics Committee

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Antwerp University Hospital

Edegem, Antwerp, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Paul Van de Heyning, Prof. dr.

Role: CONTACT

0032 3 821 47 90

Annes Claes, MSc

Role: CONTACT

0032 3 821 58 38

Facility Contacts

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Paul Van de Heyning, Prof. dr.

Role: primary

0032 3 821 47 90

Annes Claes, MSc

Role: backup

0032 3 821 58 38

References

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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.

Reference Type DERIVED
PMID: 35970164 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27895549 (View on PubMed)

Other Identifiers

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15/17/181

Identifier Type: -

Identifier Source: org_study_id

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