Study of the effect of binaural beat on clinical findings, psychoacoustic tests, EEG and ASSR 40 Hz on individuals suffering from annoying chronic tinnitus
Investigation of the effect of binaural beat on clinical findings, psycho-acoustic tests, EEG and ASSR 40 Hz on annoying chronic tinnitus sufferers
Design
It is a clinical trial study without control group with 17 tinnitus patients.
Settings and conduct
After completing the consent form, hearing evaluations will be done in all participants (normal and tinnitus subjects). In the tinnitus group, psychoacoustic evaluations (tinnitus loudness and tinnitus pitch match), VAS-L and VAS-A (Visual Analogue Scale), THI, EEG and ASSR recording will be taken before and immediately after listening to binaural beat. This study will performed in audiology department of Iran University of Medical Science.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Right handed chronic nonpulsatile tinnitus subjects(>6 months); Age between 20 and 75 years; The 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
Exclusion criteria: understanding the binaural beat ; having a remarkable cognitive problem and depression; taking of medications that affecting on central nervous system; having a history of otological, neurological, mental diseases, head trauma, psychiatric disorders, seizure.
Intervention groups
intervention group includes chronic tinnitus sufferers who will receive binaural beat stimuli intervention.
Main outcome variables
Tinnitus loudness; VAS-L; VAS-A ; THI; ASSR amplitudes; Mean frequency of EEG waves, EEG absolute & relative powers as main outcome measures and the tinnitus pitch as a secondary variable.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190507043508N1
Registration date:2019-06-10, 1398/03/20
Registration timing:registered_while_recruiting
Last update:2019-06-10, 1398/03/20
Update count:0
Registration date
2019-06-10, 1398/03/20
Registrant information
Name
Maryam Sadeghijam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
maryamjam77@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-12, 1398/02/22
Expected recruitment end date
2019-09-13, 1398/06/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of binaural beat on clinical findings, psychoacoustic tests, EEG and ASSR 40 Hz on individuals suffering from annoying chronic tinnitus
Public title
The effect of binaural beat stimulation on treatment of chronic tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
17
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 of Iran University of Medical Sciences
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Audiology Department of Iran University of Medical Science
Full name of responsible person
Maryam Sadeghijam
Street address
Audiology Department, Faculty of Rehabilitation, Iran University of Medical Science, Madadkaran St, Shahnazari St, Madar Sq
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 2225 0541
Email
sadeghigm.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Kazem Malakouti
Street address
Vice chancellor for research, Vice chancellor for International Affairs,Iran University of Medical Sciences, near Milad Tower, Shahid Hemmat Highway. Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Web page address
http://vcr.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?