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effect of pitch discrimination training on speech in noise of hearing impaired 6-10 years old children

Protocol summary

Study aim
The aim of this study is to investigate the effect of auditory rehabilitation based on pitch differentiation on speech perception in noise in hearing impaired children 6 to 10 years
Design
clinical trial without control group with convenience sampling on 18 hearing impaired children
Settings and conduct
The site of evaluation and rehabilitation is in the educational and rehabilitation center for children with hearing disorders. In this method, children with moderate to severe hearing loss evaluate before intervention with vowel consonant in noise test, sentence in noise test, pitch pattern sequence, harmonic evaluation and object-related negative wave. At the end of the intervention, the assessments were repeated and compared with before intervention. Hearing impaired children were examined as an convenience
Participants/Inclusion and exclusion criteria
age range 6 to 10 years with moderate to severe hearing loss, no auditory neuropathy, normal middle ear, lack of developmental, cognitive and behavioral problems, normal IQ, Persian language with single language Persian language parents, right hand superiority, no history of head trauma, epilepsy and seizures and use of nervous system drug
Intervention groups
. The intervention in this study is pitch training. In this type of rehabilitation, a 100 Hz complex stimulus included, frequency of 100 Hz and 10 harmonics present. Then, in different presents , each time one of the harmonics mistune and the person hears two separate sounds that compare and differentiate with the first stimulus. In the second stage, the 200Hz stimulus and in the third stage, the 300Hz stimulus present similar to 100 Hz frequency.
Main outcome variables
Consonant Vowel in noise, Sentence in noise, Pitch pattern test, Harmonic discrimination, Object Related Negativity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201109049324N1
Registration date: 2020-11-17, 1399/08/27
Registration timing: registered_while_recruiting

Last update: 2020-11-17, 1399/08/27
Update count: 0
Registration date
2020-11-17, 1399/08/27
Registrant information
Name
Nasrin Gohari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3627 1956
Email address
n.gohari@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-29, 1399/05/08
Expected recruitment end date
2020-12-14, 1399/09/24
Actual recruitment start date
2020-07-29, 1399/05/08
Actual recruitment end date
2020-12-14, 1399/09/24
Trial completion date
2020-12-14, 1399/09/24
Scientific title
effect of pitch discrimination training on speech in noise of hearing impaired 6-10 years old children
Public title
effect of pitch training on speech in noise
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
consent of parents and children to participate in the study age range 6 to 10 years and six month moderate to severe sensory neural hearing loss
Exclusion criteria:
Auditory neuropathy Developmental, cognitive and behavioral disorder Abnormal IQ History of head trauma, epilepsy and seizures and use of nervous system drug Not speaking Persian language and not having Persian language parents with single language Lack of right hand superiority Inability to perform tests
Age
From 6 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 18
Actual sample size reached: 18
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research, University of Social Welfare and Rehabilitation Sciences
Street address
No.7, Shahid Mansouri Alley., Ghodousi Bolvd.,Varamin
City
Varamin
Province
Tehran
Postal code
33716-15738
Approval date
2019-11-24, 1398/09/03
Ethics committee reference number
IR.USWR.REC.1398.137

Health conditions studied

1

Description of health condition studied
Hearing impaired
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
speech in noise
Timepoint
before intervention and2 month and 3 month after intervention
Method of measurement
speech in noise tests-CV in noise-BKB

2

Description
mistuned harmonic stimulation discrimination
Timepoint
before intervention and2 month and 3 month after intervention
Method of measurement
harmonic asessment

Secondary outcomes

1

Description
late latency response and object related negativity
Timepoint
before intervention and 2 month after intervention
Method of measurement
late latency response and object related negativity

Intervention groups

1

Description
Intervention group: 14 sessions of harmonic(pitch) discrimination rehabilitation. intervention will be performed for hearing impaired children. Harmonic changes in each session are reduced according to the individual's ability. Also, the harmonic evaluation, pitch pattern sequence , vowel consonant in noise, sentence in noise and late cortical responses and object related negative wave before and after rehabilitation are evaluated and compared. Necessary equipment is speech assessment and rehabilitation software in noise and electroencephalography device.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
rasa children hearing disorder center
Full name of responsible person
Nasrin Gohari
Street address
no.2, mehmandust building(mall)., Shohadaye 10 Dey Ave., Emam Squre., Varamin Town
City
varamin
Province
Tehran
Postal code
3371816002
Phone
+98 21 3627 1956
Email
rasacenter@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khankeh
Street address
Kudakyar Ave., Daneshju Blvd., Velenjak.,Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Fax
+98 21 2218 0109
Email
pr@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Nasrin Gohari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Kudakyar Ave.,Daneshju Blvd., Velenjak.,Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
n.gohari@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Nasrin Gohari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Kudakyar Ave., daneshju Blvd., velenjak., Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
009822180083
Email
n.gohari@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Nasrin Gohari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
kudakyarAve., Daneshju Blvd., Velenjak., Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
n.gohari@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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