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IRCT20190507043508N1 IRCT 2019-06-10 Iran University of Medical Sciences The effect of binaural beat stimulation on treatment of chronic tinnitus Study of the effect of binaural beat on clinical findings, psychoacoustic tests, EEG and ASSR 40 Hz on individuals suffering from annoying chronic tinnitus 2019-05-12 anticipated 17 Complete https://irct.ir/trial/39415 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Tinnitus. Intervention group: We have an intervention group in this study. All tinnitus patients will be treated by acoustic neuromodulation of binaural beat. They must listen to these stimuli for one month, 4 times a day, each time 15 minuets at predetermined times using personal hands free handsets or MP3 players at their most comfortable level (MCL). These stimuli are used by the MATLAB software and will be available to patients. In this study, we will use alpha binaural beat at 400 Hz frequency.. 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 No more information
public Mahdi Akbari
Audiology department, Faculty og Rehabilitation, Madadkaran St, Shahnazari St, Madar Sq
Tehran Iran (Islamic Republic of) 1445613131 +98 21 2225 0541 akbarimehdi@yahoo.com Iran University of Medical Sciences scientific Dr. Abdollah Moossavi
Iran University of Medical Sciences, near Milad Tower, Shahid Hemmat Highway. Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 2828 amoossavi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Right-handedness Chronic nonpulsatile tinnitus (>6months) Age between 20 and 75 years Normal external and middle ear function and appearance using otoscopy and tympanometry Behavioral pure-tone audiometry threshold levels of ≤20 dBHL in octave frequencies of 250–2000 Hz and not more than 40 dBHL in frequencies of 4000 -8000 Hz Filling the study consent 20 years 75 years Both Remarkable cognitive problems (MMSE over 20) Depression and anxiety (HADS scores less than 11 from 21 for either depressionand anxiety) A history of otological, neurological, mental diseases, head trauma, pregnancy, psychiatric disorders, dementia, seizure or any organic diseases that cause tinnitus Taking specific medication affecting on central nervous system The failure of understanding of binaural beat stimulation Tinnitus sufferers should not be simultaneously treated with other tinnitus treatments H93.1 Tinnitus Treatment - Other Intervention group: We have an intervention group in this study. All tinnitus patients will be treated by acoustic neuromodulation of binaural beat. They must listen to these stimuli for one month, 4 times a day, each time 15 minuets at predetermined times using personal hands free handsets or MP3 players at their most comfortable level (MCL). These stimuli are used by the MATLAB software and will be available to patients. In this study, we will use alpha binaural beat at 400 Hz frequency. Tinnitus loudness. Timepoint: Before and immediately after the treatment. Method of measurement: Audiometer instrument. Tinnitus related loudness. Timepoint: Before and immediately after the treatment. Method of measurement: Visual Analogue Scale (VAS-L). Tinnitus related annoyance(distress). Timepoint: Before and immediately after the treatment. Method of measurement: Visual Analogue Scale (VAS-A). Tinnitus Handicap Inventory. Timepoint: Before and immediately after the treatment. Method of measurement: Tinnitus Handicap Inventory Questionnaire. The amplitude of auditory steady-state potentials. Timepoint: Before and immediately after the treatment. Method of measurement: Electroencephalography instrument. Mean frequency of EEG waves. Timepoint: Before and immediately after the treatment. Method of measurement: Electroencephalography instrument. EEG absolute powers. Timepoint: Before and immediately after the treatment. Method of measurement: Electroencephalography instrument. EEG relative powers. Timepoint: Before and immediately after the treatment. Method of measurement: Electroencephalography instrument. Tinnitus pitch. Timepoint: before and after treatment. Method of measurement: Audiometer instrument. Iran University of Medical Sciences Approved 2017-04-17 Ethics committee of Iran University of Medical Sciences Milad Tower, Shiekh Fazlollah NouriShahid, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)