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Development of an Arabic Central Auditory Processing Remediation Program for Dyslexic Children With(C)APD

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ClinicalTrials.gov Identifier: NCT04708899
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : January 14, 2021
Sponsor:
Collaborator:
Alexandria University
Information provided by (Responsible Party):
Rana ElShafaei, Alexandria University

Study Description
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Brief 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).


Condition or disease Intervention/treatment Phase
Central Auditory Processing Disorder Dyslexia Behavioral: arabic version of differential processing training program Behavioral: Arabic computer based auditory traing program(CBAT) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Development of an Arabic Central Auditory Processing Remediation Program for Dyslexic Children With(Central) Auditory Processing Disorder
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cases
cases will receive the proposed program(the arabic version of differential processing training program)
 Behavioral: 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)
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in dichotic listening [ Time Frame: within 6 months ]
    assessed by screening and full version dichotic digits test pretherapy and post therapy

  2. 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

  3. Improvement in temporal processing [ Time Frame: within 6 months ]
    assessed by screening and full version pitch pattern sequence test (PPST) pretherapy and post therapy


Secondary Outcome Measures :
  1. improvement in phonological processing and awareness skills [ Time Frame: within 6month to 1 year ]
    assessed by phonological awareness assessment pretherapy and post therapy


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. dyslexic children with (C)APD
  2. Age from 6-12 years.
  3. No gender limit.
  4. Normal peripheral hearing i.e pure tone averages (average threshold from 250to 8000 Hz) should be less than or equal 25dB hearing level bilaterally.
  5. Normal speech audiometry results.
  6. Normal results on immitancemetry.
  7. Average or below average IQ.
  8. Normal language development.

Exclusion Criteria:

1. ADHD subjects. 2. Associated neurological and psychiatric disorders.

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04708899


Contacts
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Contact: Hesham Kozou, Professor 00201222666599 hesham.kozou@alexmed.edu.eg
Contact: Nesrine Hamouda, Lecturer 00201222362880 nesrinehazem@gmail.com

Locations
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Egypt
Alexandria university Recruiting
Alexandria, Azarita, Egypt, 21311
Contact: Reham Almaghraby, Professor    00201001527360    rehamma@yahoo.com   
Contact: Nesrine Hamouda, Lecturer    00201222362880    nesrinehazem@gmail.com   
Sponsors and Collaborators
Rana ElShafaei
Alexandria University
Investigators
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Study Chair: Hesham kozou, Professor Alexandria University
More Information
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Responsible Party: Rana ElShafaei, assistant lecturer of Phoniatrics (otorhinolaryngology department), Alexandria University
ClinicalTrials.gov Identifier: NCT04708899    
Other Study ID Numbers: 00018699
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The IPD sharing is denied due to subject confidentially issues.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Auditory Perceptual Disorders
Dyslexia
Language Development Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Learning Disabilities
Neurodevelopmental Disorders
 Mental Disorders
Auditory Diseases, Central
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Brain Diseases
Central Nervous System Diseases
Perceptual Disorders
Cognition Disorders
Neurocognitive Disorders