The combined effect of the behavioral rehabilitation of auditory attention and transcranial direct current stimulation on improving speech perception in noise in children with hearing loss aged 8-11 years old
The combined effect of the behavioral rehabilitation of auditory attention and transcranial direct current stimulation on improving speech perception in noise in hearing loss children
Design
one-blind clinical trial with three groups, which is assigned to rehabilitation groups by the method of 6 random blocks.
Settings and conduct
children who scored lower than the norm in auditory attention and speech in noise tests will be included in the study.will includ in the study.CV In Noise, Word in Noise tests and EEG recording will perform,too. Children will divide into three groups. Each group receives rehabilitation training.The post-test phase will be conducted for behavioral tests and EEG recording. This study is done in one-blind way and the participants do not know about the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
moderate to severe sensorineural hearing loss Children; binaural hearing aids user for at least three years: Equal or better than 30 dBHL aided hearing thresholds, Abnormal score in the BKB-SIN and at least one of the TEA-ch or mSAAT tests; Working memory capacity of at least 3 units in digit span test; normal IQ score
Non-Inclusion criteria:
Unwillingness to cooperate
Intervention groups
Group A-auditory attention training together with sham transcranial direct current stimulation (tDCS)
Group B- tDCS with behavioral sham
Group C- Combined Method (Auditory Attention Training + tDCS)
Main outcome variables
BKB Test Score; CV In Noise Test Score; Sustained attention score in the TEA- ch test; MSSAT Test Score; Word In Noise Test Score; Components of Electroencephalography (EEG)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220918055979N1
Registration date:2022-11-12, 1401/08/21
Registration timing:prospective
Last update:2022-11-12, 1401/08/21
Update count:0
Registration date
2022-11-12, 1401/08/21
Registrant information
Name
Nayiere Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 8728
Email address
mansoorynayiere@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The combined effect of the behavioral rehabilitation of auditory attention and transcranial direct current stimulation on improving speech perception in noise in children with hearing loss aged 8-11 years old
Public title
The combined effect of the behavioral rehabilitation of auditory attention and transcranial current stimulation in children with hearing loss
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with moderate to severe sensorineural hearing loss aged 8-11 years old
Permanent user of binaural hearing aids for at least three years
Equal or better than 30 dB HL aided hearing thresholds
An abnormal score in the BKB-SIN and at least one of the TEA-ch and/or mSAAT tests
right-handed
In the age range of 8-11years
Normal or corrected vision
Complete the consent form to participate in the training program
Normal findings in otoscopy and tympanometry
Working memory capacity of at least 3 units in direct didit span test
The standard IQ score or better than 85 score in Persian version of the revised Wechsler Intelligence Test for Children (R-WISC)
The ability to cooperate in carrying out the tests foreseen in the research
Exclusion criteria:
Unwillingness to cooperate in each stage of the research
Obvious developmental and behavioral problems based on the evaluation results recorded in the children's medical record
A history of obvious neurological and cognitive diseases and head trauma
Auditory neuropathy based on OAE and ABR indicators (according to children's hearing records)
Age
From 8 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
45
More than 1 sample in each individual
Number of samples in each individual:
2
binaural
Randomization (investigator's opinion)
Randomized
Randomization description
for random allocation, 8 blocks of 6 AABBCC, AABCBC, AACBCB, ABCABC, BABCAC, ACBBCA will be prepared and placed in envelopes. In order of entry of the parents, one of the envelopes was selected at random and based on the obtained block, 6 patients will be assigned to three groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In each clinical trial design, three groups can influence the results of the study. Experiments, researcher, evaluator or analyst. In this study, by randomly selecting participants in two experimental and control groups and applying independent variables to both groups, which are in one sham and play the role of placebo.
Also, the analyst is not aware of the sham of the intervention in the group and they become practically blind
Placebo
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 Rehbilitation Sciences (USWR)
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2022-10-19, 1401/07/27
Ethics committee reference number
IR.USWR.REC.1401.128
Health conditions studied
1
Description of health condition studied
Hearing Loss
ICD-10 code
H90.3
ICD-10 code description
Sensorineural hearing loss, bilateral
2
Description of health condition studied
Auditory processing disorder
ICD-10 code
H93.25
ICD-10 code description
Central auditory processing disorder
Primary outcomes
1
Description
Bamford-Kowal-Bench Sentence Test Score
Timepoint
Before the intervention - after the intervention - one month after the end of the intervention
Method of measurement
The percentage of correctly expressed target words - the amount of SNR Loss based on the calculation formula
2
Description
Consonant-Vowel In Noise Test Score
Timepoint
Before the intervention - after the intervention - one month after the end of the intervention
Method of measurement
according to percentage of correct answers
3
Description
Sustained attention score in the test of everyday attention for children (TEA- ch) score
Timepoint
Before the intervention - after the intervention - one month after the end of the intervention
Method of measurement
according to the number of correct answers
4
Description
Monaural Selective Auditory Attention Test Score
Timepoint
Before the intervention - after the intervention - one month after the end of the intervention
Method of measurement
Calculation of the percentage of correct repetition of the target words
5
Description
Word In Noise Test Score
Timepoint
Before the intervention - after the intervention - one month after the end of the intervention
Method of measurement
Calculation of 50% of words in different signal-to-noise ratios
6
Description
Components of Electroencephalography (EEG)
Timepoint
Before the intervention - after the intervention - one month after the end of the intervention
Method of measurement
With EEGLab software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A- Conventional behavioral auditory attention training will be provided together with transcranial direct current stimulation (tDCS), for 30 seconds, the current intensity of 1 mA will be applied (sham) during 10 sessions (3 sessions per week)
Category
Rehabilitation
2
Description
Intervention group: Group B-Transcranial direct current stimulation (tDCS) will be provided during 10 sessions (3 sessions per week). In each session for 20minutes, the current intensity of 1/5 mA will be applied to the participants.
Category
Treatment - Other
3
Description
Intervention group: Group C- Combined Method (Conventional behavioral auditory attention training online with transcranial direct electrical stimulation)-Conventional behavioral auditory attention training will be provided together with transcranial direct current stimulation (tDCS), for 20minutes, the current intensity of 1/5 mA will be applied during 10 sessions (3 sessions per week).