Exploring attention mechanisms in children with cochlear implants: a study on neural markers
| ISRCTN | ISRCTN14072313 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14072313 |
- Submission date
- 17/04/2025
- Registration date
- 17/04/2025
- Last edited
- 17/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
This study looks at how children with cochlear implants (CIs) process sounds and pay attention compared to children with normal hearing. The aim is to understand why some children with CIs do better than others in hearing and understanding speech, especially in noisy situations.
Who can participate?
1. Children aged 7-13 years with bilateral cochlear implants who were deaf before learning language.
2. Children with normal hearing in the same age range.
Participants must not have additional disabilities, neurological disorders, cognitive impairments, or attention deficit disorders.
What does the study involve?
Participants will:
1. Complete listening tasks while their brain activity is recorded
2. Perform speech recognition tests in noisy conditions
3. Complete memory tasks
All testing was completed in one session
What are the possible benefits and risks of participating?
Benefits:
1. Contributing to a better understanding of how cochlear implants affect attention
2. Helping improve future treatments for children with cochlear implants
Risks:
No known risks beyond minor fatigue from completing the tasks
All procedures are non-invasive
Where is the study run from?
Hadassah Medical Center (Israel)
When is the study starting and how long is it expected to run for?
May 2020 to January 2024
Who is funding the study?
University of Haifa (Israel)
Who is the main contact?
Prof. Catia Adelman, cahtiaa@hadassah.org.il
Contact information
Public, Scientific, Principal Investigator
Hachaiel Street 39/10
jerusalem
9789154
Israel
| Phone | +972 (0)5454658184 |
|---|---|
| ola.badarni6@gmail.com |
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital, Laboratory |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Neural Markers of Attention Processing in Cochlear Implant Users (NMAP-CI): an event-related potential study |
| Study acronym | NMAP-CI |
| Study objectives | Paediatric cochlear implant users would demonstrate a distinct pattern of neural attention processing. Specifically, they predicted impaired automatic attention would manifest as reduced Novelty P3 amplitudes and longer latencies, while controlled attention would remain preserved, shown by normal Target P3 amplitudes and latencies. Additionally, they expected these P3 components would correlate with behavioural performance measures such as speech perception and memory. |
| Ethics approval(s) |
Approved 06/07/2021, Helsinki Committee at Hadassah Medical Center (Hadassah Medical Center Ein Karem, jerusalem, 91120, Israel; +972 (0)2 677 7242; VHelsinki@hadassah.org.il), ref: 0881-20-HMO |
| Health condition(s) or problem(s) studied | Auditory attention processing in prelingually deaf children with bilateral cochlear implants |
| Intervention | This cross-sectional study examines neural mechanisms of attention in pediatric cochlear implant users through event-related potentials, focusing on the Novelty P3 (automatic attention) and Target P3 (controlled attention) components. The study compares prelingually deaf children with early bilateral cochlear implants (n = 25) to normal-hearing controls (n = 28), matched for gender and age (7-13 years). Participants complete an oddball paradigm during ERP recording and perform speech-in-noise and memory tasks. Participants underwent ERP measurements while performing auditory attention tasks, focusing on two distinct P3 components: Target P3 (in response to infrequent stimuli requiring response) and Novel P3 (in response to unexpected environmental sounds to be ignored). Additionally, participants completed speech-in-noise and memory tasks. No interventional treatments were administered. |
| Intervention type | Other |
| Primary outcome measure | 1. Automatic attention processing is measured using frontal Novelty P3 amplitudes and latencies from ERP recordings during an oddball paradigm at one testing session 2. Controlled attention processing is measured using parietal Target P3 amplitudes and latencies from ERP recordings during an oddball paradigm at one testing session |
| Secondary outcome measures | 1. Speech perception in noise is measured using the Speech-in-Noise test at one testing session 2. Short-term memory capacity is measured using Forward Digit Span and working memory capacity is measured using Backward Digit Span (test at one testing session) |
| Overall study start date | 15/05/2020 |
| Completion date | 09/01/2024 |
Eligibility
| Participant type(s) | Healthy volunteer, Other |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | A total of 53 participants, consisting of 25 prelingually deaf children with bilateral cochlear implants and 28 normal-hearing controls |
| Total final enrolment | 53 |
| Key inclusion criteria | Cochlear Implant (CI) Group: 1. Prelingually deaf children 2. Bilateral cochlear implant users 3. Age range 7-14 years 4. Minimum 4 years of CI experience 5. Regular CI users with consistent device use For Normal-Hearing (NH) Control Group: 1. Age-matched children: 2. Normal hearing thresholds (≤20 dB HL across frequencies) 3. No history of hearing disorders 4. No neurological disorders General Criteria for Both Groups: 1. No additional disabilities 2. Normal cognitive development 3. Written informed consent from parents/guardians 4. Ability to follow test instructions 5. Native language (Hebrew or Arabic speakers, balanced between groups) |
| Key exclusion criteria | For Both Groups: 1. Additional disabilities beyond hearing loss (for the CI group) 2. Diagnosed neurological disorders 3. Cognitive impairments 4. Attention deficit disorders 5. Inability to complete all testing sessions Specific to CI Group: 1. Irregular/inconsistent CI use 2. Device complications or malfunctions 3. Post-lingual deafness 4. Unilateral cochlear implant Specific to NH Control Group: 1. Any history of hearing loss 2. Hearing thresholds >20 dB HL at any frequency 3. History of middle ear pathology 4. Current or recent use of medications affecting cognitive function |
| Date of first enrolment | 10/08/2022 |
| Date of final enrolment | 09/01/2024 |
Locations
Countries of recruitment
- Israel
Study participating centre
91120
Israel
Sponsor information
University/education
Ein karim
Jerusalem
91120
Israel
| Phone | +972 (0)2 677 7111 |
|---|---|
| Cahtiaa@hadassah.org.il | |
| Website | http://www.hadassah-med.com/ |
"ROR" |
https://ror.org/01cqmqj90 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- UofHaifa, אוניברסיטת חיפ, جامعة حيفا
- Location
- Israel
Results and Publications
| Intention to publish date | 01/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The article has been submitted for publication. |
| IPD sharing plan | The de-identified participant data can be requested from Prof. Catia Adelman (cahtiaa@hadassah.org.il) and Ola Badarni-Zahalka (Obadar01@campus.haifa.ac.il). The type of data that will be shared: de-identified ERP recordings, behavioral test scores (speech-in-noise and memory tasks), and demographic information. Dates of availability: data will be available from publication date through 5 years post-publication. Whether consent from participants was required and obtained: written informed consent was obtained from all participants' parents/guardians Comments on data anonymization: All personal identifiers have been removed. Participants are identified only by code numbers. No identifying information, such as names, addresses, or dates of birth, is included Any ethical or legal restrictions, Data access requests must comply with Helsinki Committee guidelines. Use is limited to research purposes only. |
Editorial Notes
17/04/2025: Study's existence confirmed by the Israeli institutional Helsinki Committee.
