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IRCT20231016059744N1 IRCT 2023-11-08 Iran University of Medical Sciences Investigating the effect of speech perception training in tinnitus management Investigating the effect of speech perception in noise training on quality of life in chronic tinnitus sufferers 2023-10-23 anticipated 28 Complete https://irct.ir/trial/73213 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Tinnitus. Intervention 1: Intervention group: People in the intervention group receive 8 sessions of Word-in-Noise Training (WINT) along with Tinnitus Retraining Therapy (TRT) including counseling and sound therapy. TRT counseling includes explanations about the anatomy and physiology of the normal and damaged auditory system/the role of the central auditory system and higher cortical processes/explanation of Jasterboff's neurophysiological model about tinnitus/the importance of activating the subcortical, limbic and autonomic nervous systems in tinnitus and etc. Sound therapy also includes explaining the importance of sound enrichment, setting up sound generators and explaining their use, evaluating sound generators, etc. The Word-in-Noise Training consists of two tracks. The first track has 600 words in 60 subgroups of 10 words, and the other track has babbling noise of several speakers. In each session, 8 subgroups are presented in different signal-to-noise ratios in such a way that the words in the first subgroup are at the intensity level of 62 dB HL without noise, and the second subgroup with a signal-to-noise ratio of about 12+ dB and in the following subgroups, Each time the noise increases by 2 dB until the signal-to-noise ratio is zero. The duration of each session is 60 minutes, of which 30 minutes are devoted toTinnitus Retraining Therapy and 30 minutes to Word-in-Noise Training. Intervention 2: Control group: People in control group receive 8 sessions of Tinnitus Retraining Therapy (TRT) including counseling and sound therapy. Counseling includes explanations about the anatomy and physiology of the normal and damaged auditory system/the role of the central auditory system and higher cortical processes/explanation of Jasterboff's neurophysiological model about tinnitus/the importance of activating the subcortical, limbic and autonomic nervous systems in tinnitus and etc. Sound therapy also includes explaining the importance of sound enrichment, setting up sound generators and explaining their use, evaluating sound generators, etc. The duration of each session is 30 minutes. 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 There is no further information
public Maryam Sadeghijam
Madadkaran St., Shahnazari Ave., Madar Squ., Mirdamad Blvd., Tehran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 2059 sadeghijam.m@iums.ac.ir Iran University of Medical Sciences scientific Maryam Sadeghijam
Madadkaran St., Shahnazari Ave., Madar Squ., Mirdamad Blvd., Tehran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 2059 sadeghijam.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) People with Subjective and Chronic Tinnitus (with more than 6 months of tinnitus experience) Normal Pure Tone Hearing Threshold at Frequencies from 250 to 8000 Hz (max. dBHL25) Normal Results in Tympanometry Test (Type An) 18 years 50 years Both Obtaining more than 11 Score in the Hospital Anxiety and Depression Scale (HADS) questionnaire History of Exposure to Occupational Noise History of any Neurological Disease (including History of Head or Neck Injury, Migraine, Multiple Sclerosis, etc.) and Otological Disease (including Otosclerosis, Meniere's, Otitis, etc.) H93.1 Tinnitus Treatment - Other Treatment - Other Intervention group: People in the intervention group receive 8 sessions of Word-in-Noise Training (WINT) along with Tinnitus Retraining Therapy (TRT) including counseling and sound therapy. TRT counseling includes explanations about the anatomy and physiology of the normal and damaged auditory system/the role of the central auditory system and higher cortical processes/explanation of Jasterboff's neurophysiological model about tinnitus/the importance of activating the subcortical, limbic and autonomic nervous systems in tinnitus and etc. Sound therapy also includes explaining the importance of sound enrichment, setting up sound generators and explaining their use, evaluating sound generators, etc. The Word-in-Noise Training consists of two tracks. The first track has 600 words in 60 subgroups of 10 words, and the other track has babbling noise of several speakers. In each session, 8 subgroups are presented in different signal-to-noise ratios in such a way that the words in the first subgroup are at the intensity level of 62 dB HL without noise, and the second subgroup with a signal-to-noise ratio of about 12+ dB and in the following subgroups, Each time the noise increases by 2 dB until the signal-to-noise ratio is zero. The duration of each session is 60 minutes, of which 30 minutes are devoted toTinnitus Retraining Therapy and 30 minutes to Word-in-Noise Training. Control group: People in control group receive 8 sessions of Tinnitus Retraining Therapy (TRT) including counseling and sound therapy. Counseling includes explanations about the anatomy and physiology of the normal and damaged auditory system/the role of the central auditory system and higher cortical processes/explanation of Jasterboff's neurophysiological model about tinnitus/the importance of activating the subcortical, limbic and autonomic nervous systems in tinnitus and etc. Sound therapy also includes explaining the importance of sound enrichment, setting up sound generators and explaining their use, evaluating sound generators, etc. The duration of each session is 30 minutes. Tinnitus Loudness. Timepoint: Before the intervention and one week after the end of the intervention period. Method of measurement: Visual Analogue Scale (VAS). Tinnitus Annoyance. Timepoint: Before the intervention and one week after the end of the intervention period. Method of measurement: Visual Analogue Scale (VAS). Tinnitus Handicap. Timepoint: Before the intervention and one week after the intervention period. Method of measurement: Tinnitus Functional Index (TFI) Questionnaire. Quality of Life. Timepoint: Before the intervention and one week after the intervention period. Method of measurement: Short Form 12 (SF-12) Questionnaire. Ability to understand speech in noise. Timepoint: Before the intervention and one week after the intervention period. Method of measurement: Quick Speech in Noise Test (Quick SIN). Tinnitus Psychophysical Loudness. Timepoint: Before the intervention and one week after the intervention period. Method of measurement: Loudness Matching Using an Audiometer. Iran University of Medical Sciences Approved 2023-04-26 Ethics committee of Iran University of Medical Sciences Iran University of medical Science, Next to Milad Tower, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)