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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04611555




Registration number
NCT04611555
Ethics application status
Date submitted
20/10/2020
Date registered
2/11/2020
Date last updated
28/04/2021

Titles & IDs
Public title
ICF in Cochlear Implant Users
Scientific title
Implementation of the International Classification of Functioning, Disability and Health Model in Cochlear Implant Recipients: a Multi-center Prospective Follow-up Cohort Study
Secondary ID [1] 0 0
B3002020000137
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
CI users -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Work Rehabilitation Questionnaire (WORQ)
Timepoint [1] 0 0
One month preoperatively and six months post the activation of the speech processor
Primary outcome [2] 0 0
Change in Abbreviated Profile of Hearing Aid Benefit (APHAB)
Timepoint [2] 0 0
One month preoperatively and six months post the activation of the speech processor
Primary outcome [3] 0 0
Change in the Audio Processor Satisfaction Questionnaire (APSQ)
Timepoint [3] 0 0
One month preoperatively and six months post the activation of the speech processor
Primary outcome [4] 0 0
Change in the Speech, Spatial, and Qualities of Hearing Questionnaire with 12 items (SSQ12)
Timepoint [4] 0 0
One month preoperatively and six months post the activation of the speech processor
Primary outcome [5] 0 0
Change in the Hearing Implant Sound Quality Index 19 (HISQUI19)
Timepoint [5] 0 0
One month preoperatively and six months post the activation of the speech processor
Primary outcome [6] 0 0
Change in Pure tone audiometry
Timepoint [6] 0 0
One month preoperatively and six months post the activation of the speech processor
Primary outcome [7] 0 0
Change in Speech intelligibility
Timepoint [7] 0 0
One month preoperatively and six months post the activation of the speech processor
Primary outcome [8] 0 0
Change in Sound localization
Timepoint [8] 0 0
One month preoperatively and six months post the activation of the speech processor
Secondary outcome [1] 0 0
Change in the Nijmegen Cochlear Implant Questionnaire (NCIQ)
Timepoint [1] 0 0
One month preoperatively and six months post the activation of the speech processor
Secondary outcome [2] 0 0
Subject demographics
Timepoint [2] 0 0
One month preoperatively and six months post the activation of the speech processor

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2022
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Fiona Stanley Fremantle Hospital Group - Perth
Recruitment postcode(s) [1] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Edegem
Country [2] 0 0
Germany
State/province [2] 0 0
Würzburg
Country [3] 0 0
Poland
State/province [3] 0 0
Kajetany
Country [4] 0 0
Spain
State/province [4] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital, Antwerp
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
World Hearing Centre
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Hospital Universitario La Paz
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Fiona Stanley Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Wuerzburg University Hospital
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04611555
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ellen Andries
Address 0 0
Country 0 0
Phone 0 0
003232757372
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04611555