- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04708899
Development of an Arabic Central Auditory Processing Remediation Program for Dyslexic Children With(C)APD
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).
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hesham Kozou, Professor
- Phone Number: 00201222666599
- Email: hesham.kozou@alexmed.edu.eg
Study Contact Backup
- Name: Nesrine Hamouda, Lecturer
- Phone Number: 00201222362880
- Email: nesrinehazem@gmail.com
Study Locations
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Azarita
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Alexandria, Azarita, Egypt, 21311
- Recruiting
- Alexandria University
-
Contact:
- Nesrine Hamouda, Lecturer
- Phone Number: 00201222362880
- Email: nesrinehazem@gmail.com
-
Contact:
- Reham Almaghraby, Professor
- Phone Number: 00201001527360
- Email: rehamma@yahoo.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
1. ADHD subjects. 2. Associated neurological and psychiatric disorders.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Cases
cases will receive the proposed program(the arabic version of differential processing training program)
|
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).
|
|
Active Comparator: control
controls will receive the computer based auditory training 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in dichotic listening
Time Frame: within 6 months
|
assessed by screening and full version dichotic digits test pretherapy and post therapy
|
within 6 months
|
|
Improvement in speech discrimination in noise.
Time Frame: Within 6 months
|
assesed by screening and full version(auditory figure ground) SPIN test pretherapy and post therapy
|
Within 6 months
|
|
Improvement in temporal processing
Time Frame: within 6 months
|
assessed by screening and full version pitch pattern sequence test (PPST) pretherapy and post therapy
|
within 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
improvement in phonological processing and awareness skills
Time Frame: within 6month to 1 year
|
assessed by phonological awareness assessment pretherapy and post therapy
|
within 6month to 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Hesham kozou, Professor, Alexandria University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Otorhinolaryngologic Diseases
- Ear Diseases
- Cognition Disorders
- Neurodevelopmental Disorders
- Language Disorders
- Communication Disorders
- Learning Disabilities
- Perceptual Disorders
- Retrocochlear Diseases
- Auditory Diseases, Central
- Dyslexia
- Language Development Disorders
- Auditory Perceptual Disorders
Other Study ID Numbers
- 00018699 (Other Identifier: Ethics committee Alexandria University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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