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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04611555