Central Auditory Processing DisorderNCT04708899
Development of an Arabic Central Auditory Processing Remediation Program for Dyslexic Children With(C)APD
A study testing arabic version of differential processing training program and Arabic computer based auditory traing program(CBAT) in people with Central Auditory Processing Disorder and Dyslexia, run by Rana ElShafaei at 1 site in Egypt.
Trial summary
Rehabilitation of dyslexic children with (cental) auditory processing disorder. The first group will receive the proposed program the arabic version of differential processing training program and the control group will receive the computer based auditory traing program (CBAT). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Central Auditory Processing Disorder, Dyslexia
- What is being tested?
- arabic version of differential processing training program and Arabic computer based auditory traing program(CBAT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 20 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- dyslexic children with (C)APD
- Age from 6-12 years.
- No gender limit.
- Normal peripheral hearing i.e pure tone averages (average threshold from 250to 8000 Hz) should be less than or equal 25dB hearing level bilaterally.
- Normal speech audiometry results.
- Normal results on immitancemetry.
- Average or below average IQ.
- Normal language development.
Who cannot join
- 1. ADHD subjects. 2. Associated neurological and psychiatric disorders.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Arabic Central Auditory Processing Remediation Program for Dyslexic Children With(Central) Auditory Processing Disorder
Rehabilitation of dyslexic children with (cental) auditory processing disorder.
The first group will receive the proposed program the arabic version of differential processing training program and the control group will receive the computer based auditory traing program (CBAT).
Read the detailed description
Central Auditory Processing Disorder(C)APD is defined as difficulty for children with normal hearing to listen selectively in the presence of noise, to combine information from two ears properly, to process speech when it is slightly degraded, and to integrate auditory information when it is delivered faster than the individual with (C)APD can process.( The estimated prevalence of (C)APD in the school-aged population is approximately 2 to 5 %, and the estimated prevalence of (C)APD in the older adult population is 76 %. These percentages are higher than those affected by hearing loss.
Dyslexia and (C)APD are common comorbidities and since there is limited research on (C)APD within each related academic discipline. Furthermore the language, audiologiological , and cognitive nature of the disorder confirmed that a multi-disciplinary effort is needed in order to provide clinical decision and effective intervention for the (C)APD population. Hence Development of additional intervention tools for use in clinics, schools and home settings is warranted .
The aim of this work is to develop a novel Arabic (C)APD remediation program ,to study the outcome of the program and to validate it's effectiveness by comparing it to the Arabic computer based auditory training(CBAT) program.
- Conditions
- Central Auditory Processing Disorder, Dyslexia
- Being tested
- arabic version of differential processing training program, Arabic computer based auditory traing program(CBAT)
- Medical subject headings
- Language Development Disorders, Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arabic version of differential processing training programBehavioural
comprehensive training program for central auditory processing disorder contains auditory and linguistic tasks (language organization, phonemic and phonetic awareness, dichotic listening,temporal patterning and auditory discrimination).
Arabic computer based auditory traing program(CBAT)Behavioural
comprehensive computer based traing program for central auditory processing disorder contains auditory memory, temporal processing, dichotic listening , selective attention and phonemic awareness games.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Active comparator | cases will receive the proposed program(the arabic version of differential processing training program) Receives: Behavioral: arabic version of differential processing training program |
| control | Active comparator | controls will receive the computer based auditory training program (CBAT) Receives: Behavioral: Arabic computer based auditory traing program(CBAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on dichotic listening
assessed by screening and full version dichotic digits test pretherapy and post therapy
Measured: within 6 months
Effect on speech discrimination in noise.
assesed by screening and full version(auditory figure ground) SPIN test pretherapy and post therapy
Measured: Within 6 months
Effect on temporal processing
assessed by screening and full version pitch pattern sequence test (PPST) pretherapy and post therapy
Measured: within 6 months
Secondary outcomes (1)
change in phonological processing and awareness skills
assessed by phonological awareness assessment pretherapy and post therapy
Measured: within 6month to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Mar 2020
- Primary completion20 Mar 2022
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Auditory Processing DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Rehabilitation of dyslexic children with (cental) auditory processing disorder. The first group will receive the proposed program the arabic version of differential processing training program and the control group will receive the computer based auditory traing program (CBAT).
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rana ElShafaei
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Rana ElShafaei, Alexandria University
- Investigators
- Hesham kozou, Professor, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708899
- Sponsor's protocol ID
- 00018699
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD sharing is denied due to subject confidentially issues.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Arabic Central Auditory Processing Remediation Program for Dyslexic Children With(Central) Auditory Processing Disorder
- ClinicalTrials.gov ID
- NCT04708899
- Acronym / sponsor ID
- 00018699
- Conditions
- Central Auditory Processing Disorder, Dyslexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Rana ElShafaeiUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 14 Jan 2021 (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.
Rehabilitation of dyslexic children with (cental) auditory processing disorder.
The first group will receive the proposed program the arabic version of differential processing training program and the control group will receive the computer based auditory traing program (CBAT).
Detailed description
Central Auditory Processing Disorder(C)APD is defined as difficulty for children with normal hearing to listen selectively in the presence of noise, to combine information from two ears properly, to process speech when it is slightly degraded, and to integrate auditory information when it is delivered faster than the individual with (C)APD can process.( The estimated prevalence of (C)APD in the school-aged population is approximately 2 to 5 %, and the estimated prevalence of (C)APD in the older adult population is 76 %. These percentages are higher than those affected by hearing loss.
Dyslexia and (C)APD are common comorbidities and since there is limited research on (C)APD within each related academic discipline. Furthermore the language, audiologiological , and cognitive nature of the disorder confirmed that a multi-disciplinary effort is needed in order to provide clinical decision and effective intervention for the (C)APD population. Hence Development of additional intervention tools for use in clinics, schools and home settings is warranted .
The aim of this work is to develop a novel Arabic (C)APD remediation program ,to study the outcome of the program and to validate it's effectiveness by comparing it to the Arabic computer based auditory training(CBAT) program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Rehabilitation of dyslexic children with (cental) auditory processing disorder. The first group will receive the proposed program the arabic version of differential processing training program and the control group will receive the computer based auditory traing program (CBAT).
| Arm | Type | Receives |
|---|---|---|
| Cases | Active comparator | Behavioral: arabic version of differential processing training programcases will receive the proposed program(the arabic version of differential processing training program) |
| control | Active comparator | Behavioral: Arabic computer based auditory traing program(CBAT)controls will receive the computer based auditory training program (CBAT) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- dyslexic children with (C)APD
- Age from 6-12 years.
- No gender limit.
- Normal peripheral hearing i.e pure tone averages (average threshold from 250to 8000 Hz) should be less than or equal 25dB hearing level bilaterally.
- Normal speech audiometry results.
Key exclusion criteria (2 listed)
- 1. ADHD subjects. 2. Associated neurological and psychiatric disorders.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arabic version of differential processing training programcomprehensive training program for central auditory processing disorder contains auditory and linguistic tasks (language organization, phonemic and phonetic awareness, dichotic listening,temporal patterning and auditory discrimination). | Behavioural | Cases |
| Arabic computer based auditory traing program(CBAT)comprehensive computer based traing program for central auditory processing disorder contains auditory memory, temporal processing, dichotic listening , selective attention and phonemic awareness games. | Behavioural | control |
Primary outcome
Effect on dichotic listening
Time frame: within 6 months
assessed by screening and full version dichotic digits test pretherapy and post therapy
Effect on speech discrimination in noise.
Time frame: Within 6 months
assesed by screening and full version(auditory figure ground) SPIN test pretherapy and post therapy
Effect on temporal processing
Time frame: within 6 months
assessed by screening and full version pitch pattern sequence test (PPST) pretherapy and post therapy
1 secondary outcome
change in phonological processing and awareness skills
Time frame: within 6month to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: No. The IPD sharing is denied due to subject confidentially issues.
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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. This study is not recruiting at the moment.
Hesham kozou, Professor study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arabic version of differential processing training program and Arabic computer based auditory traing program(CBAT) in people with Central Auditory Processing Disorder and Dyslexia, run by Rana ElShafaei at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on dichotic listening (time frame: within 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.