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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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B3002020000137
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hearing Loss
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Condition category
Condition code
Ear
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Deafness
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
CI users -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Work Rehabilitation Questionnaire (WORQ)
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Assessment method [1]
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The WORQ was divided into two sections. Section one contains 18 sociodemographic and work-related questions regarding the four environmental categories from the brief ICF Core Set. The six categories from activities and participation that describe vocational education or work situations namely were also included in section one. In the main section of WORQ, 36 questions were phrased representing 34 categories. The WORQ has been revised to match the core needs of the cochlear implant ICF codes. The revised version includes 4 items in the first section and 14 items in the main section, taking less than 5 minutes to complete.
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Timepoint [1]
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One month preoperatively and six months post the activation of the speech processor
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Primary outcome [2]
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Change in Abbreviated Profile of Hearing Aid Benefit (APHAB)
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Assessment method [2]
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The APHAB is a 24-item questionnaire derived from the original 66-item Profile of Hearing Aid Benefit. The self-assessment instrument evaluates hearing impairment in real-life situations with and without hearing aids. Participants have to rate how often a given statement is true in their daily life, based on the following seven response alternatives: always (99%), almost always (87%), generally (75%), half-the-time (50%), occasionally (25%), seldom (12%) and never (1%). Ease of communication, reverberation, background noise and aversiveness of sounds make up the four subscales of APHAB. In the first three subscales, higher scores suggest less hearing disability, while lower scores indicate less hearing disability in the aversiveness subscale. The APHAB typically requires 10 minutes or less to complete.
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Timepoint [2]
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One month preoperatively and six months post the activation of the speech processor
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Primary outcome [3]
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Change in the Audio Processor Satisfaction Questionnaire (APSQ)
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Assessment method [3]
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The APSQ is a general questionnaire which is designed to assess the handling hearing devices, taking 5 minutes to complete. It assesses the wearing comfort, sound quality, and other device-specific factors related to the audio processor with 15 items on a VAS scale from 0 ('does not agree at all') to 10 ('fully agrees'). If an item does not apply to the subject, then the subject can tick the 'not applicable' option. The maximum number of incomplete answers for the validation analyses is set at three items per subject; if this number exceeds, then the subject shall be excluded. Hence, if participants do not wear at least one hearing device preoperatively, they will only complete in the questionnaire 6 months postactivation.
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Timepoint [3]
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One month preoperatively and six months post the activation of the speech processor
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Primary outcome [4]
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Change in the Speech, Spatial, and Qualities of Hearing Questionnaire with 12 items (SSQ12)
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Assessment method [4]
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The SSQ12 is designed to measure self-reported auditory disability across a wide variety of domains, reflecting the reality of hearing in the everyday world. It takes approximately 5 minutes to complete and it covers: hearing speech in a variety of competing contexts, the directional, distance, and movement components of spatial hearing, segregation of sounds and attending to simultaneous speech streams, ease of listening, the naturalness, clarity, and identifiability of different speakers, different musical pieces and instruments, and different everyday sounds.
The SSQ12 consists of 12 questions that the subjects score on a scale from 0 (not at all) to 10 (perfectly). The total score is the sum of all items and can range between 0 and 120.
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Timepoint [4]
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One month preoperatively and six months post the activation of the speech processor
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Primary outcome [5]
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Change in the Hearing Implant Sound Quality Index 19 (HISQUI19)
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Assessment method [5]
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The HISQUI19 is a self-administered questionnaire to quantify the individual perceived sound quality of hearing implanted patients in daily life. The questionnaire consists of 19 seven-level Likert items ranging from "always (99%)" to "never (1%)", taking approximately 10 minutes to complete. Added percentage values support the answering. The total score is the sum of all items and ranges from 19 to 133 points. Missing data and the answer option ´not applicable' (N/A) are treated as ´missing values'. The maximum number of incomplete answers are set at three items per subject; if this number exceeds the subject shall be excluded.
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Timepoint [5]
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One month preoperatively and six months post the activation of the speech processor
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Primary outcome [6]
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Change in Pure tone audiometry
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Assessment method [6]
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Pure tone audiometry will be performed according to current clinical standards (ISO 8253-1, 2010) by an experienced Good Clinical Practice (GCP) certificated audiologist (Master of science). Pre- and postoperatively, best-aided pure tone audiometry will be measured at 500, 1000, 2000, 4000 and 8000 Hz using warble tones in sound field in a sound treated booth. The loudspeaker will be placed in front of the participant at ear level at 1 meter distance. The best-aided pure tone average (PTA4) will be calculated by averaging participants' hearing thresholds at 500, 1000, 2000 and 4000 Hz in best-aided condition.
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Timepoint [6]
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One month preoperatively and six months post the activation of the speech processor
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Primary outcome [7]
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Change in Speech intelligibility
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Assessment method [7]
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Speech intelligibility will be evaluated in quiet, using disyllables in Spanish and monosyllables in the other languages, and in noise, using sentences. These tests will be performed pre- and postoperatively in best-aided situation according to current clinical standards (ISO 8253-1, 2010). Participants will be sitting in front of the loudspeaker, positioned at ear level, at a one-meter distance. They will be instructed to repeat the speech stimuli they hear. Speech materials and assessment methods are aligned across the different centers cooperating in this study to obtain comparable results.
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Timepoint [7]
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One month preoperatively and six months post the activation of the speech processor
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Primary outcome [8]
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Change in Sound localization
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Assessment method [8]
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Each center will use its own particular localization set-up. Centers not disposing of an appropriate set-up will only use the SSQ12 spatial subscale. The other centers use both the subjective SSQ12 and the objective localization test.
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Timepoint [8]
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One month preoperatively and six months post the activation of the speech processor
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Secondary outcome [1]
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Change in the Nijmegen Cochlear Implant Questionnaire (NCIQ)
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Assessment method [1]
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The NCIQ is a disease-specific measure for QOL and focuses on the needs of CI recipients. It consists of 60 items, taking approximately 15 minutes to complete and it is categorized in the following subdomains: Sound perception basic, Sound perception advanced, Speech production, Self-esteem, Activity and Social interactions. Each subdomain contains 10 items. 55 of the total of 60 items are formulated as statements with 5 answer categories to indicate the degree to which the statement is true: never (1), sometimes (2), often (3), mostly (4), and always (5). The other 5 items will be answered according to the CI user's ability to perform the action in question: no (1), poorly (2), moderate (3), adequate (4), and good (5). If a statement does not apply to a patient, a sixth answer can be given: "not applicable." Missing values and the response category "not applicable" will be both treated as not completed.
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Timepoint [1]
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One month preoperatively and six months post the activation of the speech processor
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Secondary outcome [2]
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Subject demographics
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Assessment method [2]
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Subject demographics will be retrieved from the participants' medical file or by asking them if the information is not available. The 11th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-11) classification will be used to code subjects' health conditions.
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Timepoint [2]
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One month preoperatively and six months post the activation of the speech processor
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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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/08/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2022
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Fiona Stanley Fremantle Hospital Group - Perth
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Recruitment postcode(s) [1]
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- Perth
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Edegem
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Country [2]
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Germany
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State/province [2]
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Würzburg
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Country [3]
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Poland
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State/province [3]
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Kajetany
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Country [4]
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Spain
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State/province [4]
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Madrid
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Hospital, Antwerp
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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World Hearing Centre
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Hospital Universitario La Paz
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Fiona Stanley Hospital
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Wuerzburg University Hospital
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04611555
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ellen Andries
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Address
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Country
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Phone
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003232757372
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04611555
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