Clinical trial NCT04611555: ICF in Cochlear Implant Users
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss
Keywords: Cochlear Implantation
International Classification of Functioning, Disability and Health
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: World Hearing Centre
name: Hospital Universitario La Paz
name: Fiona Stanley Hospital
name: Wuerzburg University Hospital
First posted: 2020-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult subjects (≥18 years old) eligible for cochlear implantation, considering the local criteria of reimbursement.

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.


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

Primary outcomes:
measure: Change in Work Rehabilitation Questionnaire (WORQ)
timeFrame: One month preoperatively and six months post the activation of the speech processor
measure: Change in Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: One month preoperatively and six months post the activation of the speech processor
measure: Change in the Audio Processor Satisfaction Questionnaire (APSQ)
timeFrame: One month preoperatively and six months post the activation of the speech processor
measure: Change in the Speech, Spatial, and Qualities of Hearing Questionnaire with 12 items (SSQ12)
timeFrame: One month preoperatively and six months post the activation of the speech processor
measure: Change in the Hearing Implant Sound Quality Index 19 (HISQUI19)
timeFrame: One month preoperatively and six months post the activation of the speech processor
measure: Change in Pure tone audiometry
timeFrame: One month preoperatively and six months post the activation of the speech processor
measure: Change in Speech intelligibility
timeFrame: One month preoperatively and six months post the activation of the speech processor
measure: Change in Sound localization
timeFrame: One month preoperatively and six months post the activation of the speech processor
Secondary outcomes:
measure: Change in the Nijmegen Cochlear Implant Questionnaire (NCIQ)
timeFrame: One month preoperatively and six months post the activation of the speech processor
measure: Subject demographics
timeFrame: One month preoperatively and six months post the activation of the speech processor
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Fiona Stanley Fremantle Hospital Group
city: Edegem
country: Belgium
facility: University Hospital Antwerp
city: Würzburg
country: Germany
facility: University Clinic of Würzburg
city: Kajetany
country: Poland
facility: World Hearing Centre
city: Madrid
country: Spain
facility: Hospital La Paz
Study officials:
References: