Protocol summary

Summary
This study with aiming to decreasing ear asymmetry and increasing speech in noise recognition ability will be conducted in LD children. Their inclusion criteria will be including abnormal ear asymmetry and weakness in speech in noise recognition. They will be randomly allocated into three groups (n= 10, each): group I(intervention with multi-talker babble noise); goupe II (intervention without multi-talker babble noise); and control group (without intervention). Pre- and post- treatment tests will be PrDDT, PCWT, PCST, PARWIN, FARDIN. Intervention based on binaural integration and separation in multitalker babble noise by using recency effect will be performed in one- hour sessions, 3 times per week for 5 consequent weeks. Auditory memory potentiating practice will be added at the later stage of intervention. Pre- and post- results will be compared among groups.

General information

Acronym
LD= learning disability PRDD= Persian randomized dichotic digit test PCW= Persian competing words
IRCT registration information
IRCT registration number: IRCT2015100524360N1
Registration date: 2016-02-06, 1394/11/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-06, 1394/11/17
Registrant information
Name
Akram Pourbakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 0541
Email address
pourbakht.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development of a dichotic listening training program and comparison of its effect with and without multi-talker babble on recognition of speech in noise in learning-disabled children
Public title
The effect of dichotic training program in learning-disabled children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: No hearing loss or middle ear pathologies; good SRT; WRTsnr less than 2 SD of PARWIN; Ear asymmetry more than 2 SD in CST Exclusion criteria: Patient refusal from study
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemmat high way
City
Tehran
Postal code
Approval date
2015-09-22, 1394/06/31
Ethics committee reference number
IR.IUMS.rec.1394.26484

Health conditions studied

1

Description of health condition studied
Learining disability
ICD-10 code
F81.9
ICD-10 code description
Developmental disorder of scholastic skills, unspecified

Primary outcomes

1

Description
speech recognition in noise
Timepoint
before and a week and a month after intervention
Method of measurement
PrDDT, PCWT, PCST, PARWIN, FARDIN

Secondary outcomes

1

Description
Auditory communication improvement
Timepoint
before and a week and a month after intervention
Method of measurement
questionnaire and interviewing teachers and parents

Intervention groups

1

Description
Group I will be intervened by dichotic listening to digits, words and sentences presented to the poorer ear with latency varying from 1000 to 0 ms. From the third week, the intervention continue in the presence of multitalker babble noise . Signal to noise ratio is decreased gradually from +15 dB to +5 dB. In the fourth week, several auditory practices for binaural separation will be considered. In the fifth week, some practices are intended to enhance auditory memory.
Category
Rehabilitation

2

Description
Group II will be intervened by dichotic listening to digits, words and sentences presented to the poorer ear with latency varying from 1000 to 0 ms. In the fourth week, several auditory practices for binaural separation will be considered. In the fifth week, some practices are intended to enhance auditory memory.
Category
Rehabilitation

3

Description
The control group will not receive any intervention and participate in the pre- and post- tests.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Rehabilitation, primary schools in Tehran
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
deputy of research
Street address
Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pourbakht Akram
Position
Head of Dept/ Associate Professor
Other areas of specialty/work
Street address
Iran
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
pourbakht.a@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Akram Pourbakht
Position
PhD Student in Audiology
Other areas of specialty/work
Street address
Iran
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
pourbakht.a@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pourbakht Akram
Position
head of Dept/ Associate Professor
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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