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ClinicalTrials.gov ID

NCT04611555

Lead Sponsor

University Hospital, AntwerpOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

100Estimated

Last Update Posted

Apr 28, 2021Actual

Start Date

Aug 31, 2020Actual

Primary Completion Date

Jun 2022Estimated

Completion Date

Jun 2022Estimated

Official Title

Implementation of the International Classification of Functioning, Disability and Health Model in Cochlear Implant Recipients: a Multi-center Prospective Follow-up Cohort Study

Brief Summary

The current project proposes a multi-center prospective follow-up cohort study aiming to realize an international framework to classify human functioning and disability in Cochlear Implant (CI) recipients using a standardized ICF framework. For this, ICF qualifiers which denote the magnitude of the level of health or severity of the problem will be quantified to enable comparison of data across countries and health-care disciplines. Adult subjects (≥18 years old) eligible for cochlear implantation, considering the local criteria of reimbursement, will be assessed one month preoperatively and six months post the activation of the speech processor using three audiological examinations, evaluating the participants' localization abilities, speech recognition and hearing thresholds, and six questionnaires, each evaluating different aspects of daily life functioning and disability in hearing-impaired persons.

• Hearing Loss

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

1. General

   • Adults aged 18 years or older with postlingual HL
   • Signed and dated informed consent, informed permission and/or minors assent.
   • Willingness to participate in evaluations, test sessions, and medical follow-up sessions as defined in the protocol.
   • Physical and mental competence to participate in fitting of the device and follow-up sessions as defined in the protocol.
   • Fluency in the language of the implanting centre.

2. Audiological

   • Completion of hearing assessment battery showing suitability of the CI candidates.
   • Compliance with cochlear implant candidate selection criteria of the implanting centre.
   • First cochlear implantation

3. Medical

   • Patent cochlea, as evidenced by High-resolution computed tomography (HRCT) and/or Magnetic Resonance Imaging (MRI).

Exclusion Criteria:

1. General

   • Re-implantation of the cochlear implant
   • No motivation to participate in the study and/or unreasonable expectations.

2. Medical

   • Presence of contra-indications for surgery in general and cochlear implantation in particular.
   • Presence of central auditory lesions.
   • Autoimmune disease, meningitis or ossification of the cochlea.
   • Radiological evaluation indicating malformation or obstruction of the cochlea.
   • Unstable psychological status.
   • Any disorder that may relate to an increased risk of skin flap problems
   • Having received chemotherapy
   • Be a burn victim

3. Use of one of the following electrodes for implantation

   • Compressed
   • Split
   • Any type of custom made electrodes

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

University Hospital, AntwerpOTHER

Collaborators

World Hearing CentreUNKNOWN

Hospital Universitario La PazOTHER

Fiona Stanley HospitalOTHER

Wuerzburg University HospitalOTHER

miryamcf@yahoo.com