Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT06841900

Acronym / sponsor ID

ICF in Paediatric CI users

Conditions

Cochlear Impant Children

Study type

Observational

Recruitment status

Not yet recruiting

Enrolment

120 participants (estimated)

Lead sponsor

University Hospital, AntwerpUniversity, hospital or other

Study start

Mar 2025 (estimated)

Primary completion

Mar 2027 (estimated)

Study completion

Mar 2027 (estimated)

First posted

24 Feb 2025 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

1 Year

Number of arms

1

Who may qualify

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Study population

Paediatric Cochlear Implant (CI) recipients (<18 years) with prelingual sensorineural hearing loss

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Change in LittlEARS® Auditory Questionnaire (LEAQ)

   Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

   The LittlEARS® Auditory Questionnaire (LEAQ) was created to aid professionals and caregivers in the assessment of auditory capabilities among infants and toddlers experiencing hearing impairment. Grounded in the observations made by caregivers concerning the auditory responses exhibited by their children in everyday settings, this questionnaire comprises 35 questions tailored to specific age groups, necessitating responses of either 'yes' or 'no'. These questions are designed to capture significant milestones in auditory development during the initial two years of life or within the first two years following the onset of hearing intervention for children utilizing hearing devices. The questionnaire is suitable for children up to 24 months old, or with a hearing age of 24 months.

2. Change in Speech, Spatial and Qualities of Hearing Scale for Parents (SSQ-P)

   Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

   The original SSQ was adapted for use in children, resulting in the development of the SSQ-P. Each of the 23 items in the questionnaire presents a scenario followed by a question regarding the child's hearing ability within that scenario. These items are categorized into three dimensions: speech perception, spatial hearing, and qualities of hearing. Parents are tasked with providing a rating between 0 and 10 for each item, where 0 signifies that the child could not perform in the scenario at all and 10 indicates perfect performance. Additionally, parents are asked to indicate how frequently the scenario would occur and to rate the importance of the listening skills required for that scenario.

3. Change in Speech Intelligibility Rating (SIR)

   Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

   The Speech Intelligibility Rating (SIR) comprises spoken passages, wherein the degree of intelligibility is evaluated using an interval scale spanning from 0 to 10, ensuring uniformity in rating perception. The SIR assessment uses 20 standardized passages delivered by a single speaker, each identified as possessing comparable levels of intelligibility. The SIR is typically used in children with hearing loss from around the age of 2 years old .

4. Parent's Evaluation of Aural/Oral Performance of Children (PEACH)

   Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

   The PEACH is a 13-item questionnaire designed for parental assessment of a 3- to 7-year-old child's aural and oral abilities in everyday life. The PEACH asks parents to consider their child's listening behaviors over the past week and then assigns a numerical value to the answers ranging from 0 (Never or 0 %) to 4 (Always or 75 to 100 %). The PEACH questions assess listening behaviors in both quiet and noisy surroundings.

5. Standard pure tone audiometry, Behavioral Observation Audiometry (BOA), Visual Reinforcement Audiometry (VRA) or Play Audiometry

   Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

   Standard pure tone audiometry, Behavioral Observation Audiometry (BOA), Visual Reinforcement Audiometry (VRA) or Play Audiometry will be performed according to current clinical standards (ISO 8253-1, 2010), depending on the age of the participant. Pre- and postoperatively, best-aided audiometry will be measured at 250, 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, primary outcome measurement) will be calculated by averaging participants' hearing thresholds at 500, 1000, 2000 and 4000 Hz in best-aided condition.

6. Auditory Brainstem Response (ABR) Audiometry

   Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

   ABR audiometry involves the generation of an evoked potential through a brief auditory stimulus (e.g., click, chirp, etc.) transmitted via an acoustic transducer (insert earphone or headphone). The resulting waveform response is detected by surface electrodes positioned at the vertex of the scalp and ear lobes. The signal's amplitude is averaged and plotted against time and waveform peaks are identified as I-VII. These waveforms typically occur within a 10-millisecond window following a click stimulus presented at high intensities (70-90 dB normal hearing level [nHL]). ABR audiometry is suitable for children of all ages.

7. Ling Sounds (detection/discrimination)

   Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

   For Ling sound detection, the participants' detection of six sounds (oo, ah, ee, mm, sh, ss) will be observed in a variety of game formats. In the clinic, each sound is presented six times without lipreading, and the child simply responds. Score "S" will be given if the skill is emerging, score "A" will be given if the child has been observed to carry out the tasks consistently. For Ling discrimination, the phoneme "ee" will be repeated and all six Ling Sounds will be randomly inserted. Score "S" will be given if the child is consistently able to discriminate any one sound out of the six, score "A" will be given if the child is consistently able to discriminate all six sounds. The Ling test is suitable for children from approximately 6 months of age to adulthood.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
• Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

6 sites in 6 countries: see every site and its status.