Objectives: This study is a basic and an applicable one surveying the effect of vowel auditory training on concurrent speech segregation in hearing impaired children. Concurrent segregation is one of the basic components of auditory scene analysis (ASA) and is very important for speech perception.
Design: Concurrent speech segregation will be measured with auditory late potentials (N1-P2 amplitude and latency) and auditory behavioral tests (reaction time and identification score in percent) for all of the children referred from centers of University of social welfare and rehabilitation sciences.
Setting: Firstly, auditory late responses and auditory behavioral responses will be recorded from 30 hearing impaired children (Control group=15 and Test group=15). Secondly, vowel auditory training will be conducted for 15 hearing impaired children (Test group) for 3-6 months (2 sessions in per week). Finally, all of the responses will be recorded and compared between both groups.
Participants: 30 hearing impaired children (4-6 years old) with moderate to severe sensory-neural hearing loss. All of the children have binaural hearing aids. Matching children will be based on age, parent’s education level, and birth order.
Measures: Auditory behavioral tests and auditory late response (N1-P2) will be assessed.
Intervention: Vowel auditory training will be conducted for 3 months and 6 months.
Main outcomes: N1-P2 amplitude, N1-P2 latency, Reaction time, Identification score in percent
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011912174N1
Registration date:2013-02-05, 1391/11/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-05, 1391/11/17
Registrant information
Name
Hossein Talebi
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0100
Email address
h.talebi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-04-20, 1392/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vowel auditory training on auditory late and behavioral responses of hearing impaired children
Public title
Effect of vowel auditory training on concurrent speech segregation of hearing impaired children
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria; 4-6 years old children with symmetric moderate to severe sensory-neural hearing loss; All of the children have binaural hearing aids; Matching children is conducted on base of age, parent’s education level and birth order.
Exclusion criteria; Children with profound sensory-neural hearing loss; Children with otits media, Children with asymmetric hearing loss
Age
From 3 years old to 6 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of social welfare and rehabilitation sciences
Street address
University of social welfare and rehabilitation sciences, Kudakyar Avenue, Daneshjoo Boulevard, Evin
City
Tehran
Postal code
1985713834
Approval date
2012-01-30, 1390/11/10
Ethics committee reference number
21578
Health conditions studied
1
Description of health condition studied
Hearing loss
ICD-10 code
H90.3
ICD-10 code description
Sensorineural hearing loss, bilateral
Primary outcomes
1
Description
N1-P2 Latency
Timepoint
Pre intervention, 3 months after intervention, 6 months after intervention
Method of measurement
miliseconds/ BioLogic system
2
Description
N1-P2 Amplitude
Timepoint
Pre intervention, 3 months after intervention, 6 months after intervention
Method of measurement
microvolt/ Biologic system
3
Description
Identification score
Timepoint
Pre intervention, 3 months after intervention, 6 months after intervention
Method of measurement
Percent
4
Description
Reaction time
Timepoint
Pre intervention, 3 months after intervention, 6 months after intervention
Method of measurement
miliseconds/ timer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Vowel auditory training including vowels ae, er, oo, ah, and ee will be conducted to discriminate and identify those for 3 to 6 months.
Category
Rehabilitation
2
Description
Control group will receive auditory rehabilitation and vowel auditory training (intervention) will not introduce to this group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of social welfare and rehabilitation sciences
Full name of responsible person
Mahbubeh Khorshidi
Street address
Department of audiology, University of social welfare and rehabilitation sciences, Kudakyar Avenue, Daneshjoo Bulevard, Evin
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of University of social welfare and rehabilitation sciences
Full name of responsible person
Mohammad Shakeri
Street address
University of social welfare and rehabilitation sciences, Kudakyar Avenue, Daneshjoo Boulevard, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Hossein Talebi
Position
PhD candidate
Other areas of specialty/work
Street address
Department of audiology, University of social welfare and rehabilitation sciences, Kudakyar Avenue, Daneshjoo Bulevard, Evin
City
Tehran
Postal code
Phone
+98 21 2218 0100
Fax
Email
ht6023@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hossein Talebi
Position
PhD candidate of audiology
Other areas of specialty/work
Street address
Department of audiology, University of social welfare and rehabilitation sciences, Kudakyar Avenue, Daneshjoo Bulevard, Evin
City
Tehran
Postal code
Phone
+98 21 2218 0100
Fax
Email
ht6023@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)