NCT04708899

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

2.1 years

First QC Date

January 12, 2021

Last Update Submit

February 1, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Effect on dichotic listening

    assessed by screening and full version dichotic digits test pretherapy and post therapy

    within 6 months

  • Effect on speech discrimination in noise.

    assesed by screening and full version(auditory figure ground) SPIN test pretherapy and post therapy

    Within 6 months

  • Effect on temporal processing

    assessed by screening and full version pitch pattern sequence test (PPST) pretherapy and post therapy

    within 6 months

Secondary Outcomes (1)

  • change in phonological processing and awareness skills

    within 6month to 1 year

Study Arms (2)

Cases

ACTIVE COMPARATOR

cases will receive the proposed program(the arabic version of differential processing training program)

Behavioral: arabic version of differential processing training program

control

ACTIVE COMPARATOR

controls will receive the computer based auditory training program (CBAT)

Behavioral: Arabic computer based auditory traing program(CBAT)

Interventions

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).

Cases

comprehensive computer based traing program for central auditory processing disorder contains auditory memory, temporal processing, dichotic listening , selective attention and phonemic awareness games.

control

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • \. ADHD subjects. 2. Associated neurological and psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria university

Alexandria, Azarita, 21311, Egypt

Location

MeSH Terms

Conditions

Language Development DisordersDyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpecific Learning DisorderLearning DisabilitiesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hesham kozou, Professor

    Alexandria University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer of Phoniatrics (otorhinolaryngology department)

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 14, 2021

Study Start

March 1, 2020

Primary Completion

March 20, 2022

Study Completion

March 20, 2022

Last Updated

February 3, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

The IPD sharing is denied due to subject confidentially issues.

Locations