]>
IRCT20220918055979N1 IRCT 2022-11-12 University of social welfare and rehabilitation sciences The combined effect of the behavioral rehabilitation of auditory attention and transcranial current stimulation in children with hearing loss 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 2022-12-01 anticipated 45 Complete https://irct.ir/trial/66018 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Condition 1: Hearing Loss. Condition 2: Auditory processing disorder. Intervention 1: 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). Intervention 2: 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. Intervention 3: 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). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We will publish it if necessary
public Nayiere Mansouri
kodakyar Ave, daneshjo Blvd, Evin
Tehran Iran (Islamic Republic of) 1985713871 +98 914 454 6572 mansoorynayiere@gmail.com University of social welfare and rehabilitation sciences scientific Nayiere Mansouri
kodakyar Ave, daneshjo Blvd, Evin
Tehran Iran (Islamic Republic of) 1985713871 +98 914 454 6572 mansoorynayiere@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) 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 8 years 11 years Both 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) H90.3 H93.25 Sensorineural hearing loss, bilateral Central auditory processing disorder Rehabilitation Treatment - Other Rehabilitation 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) 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. 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). 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. 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. 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. 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. 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. 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. University of social welfare and rehabilitation sciences Approved 2022-10-19 Ethics committee of University of Social Welfare and Rehbilitation Sciences (USWR) kodakyar Ave., daneshjo Blvd.,Evin Tehran Tehran Iran (Islamic Republic of)