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Trial registered on ANZCTR
Registration number
ACTRN12612000455864
Ethics application status
Approved
Date submitted
19/04/2012
Date registered
24/04/2012
Date last updated
24/04/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Low-level laser therapy for improvement of tinnitus associated with noise-induced hearing loss
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Scientific title
Low-level laser therapy for improvement of tinnitus associated with NIHL among workers exposed to loud noise
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Secondary ID [1]
280365
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Nil
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Universal Trial Number (UTN)
U1111-1130-1023
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
tinnitus
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Noise-induced hearing loss
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Condition category
Condition code
Ear
286582
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0
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Other ear disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Low-level laser therapy
Laser properties: 5mv laser with a wavelength of 650nm
Duration & frequency:20 minutes each session,every other day
Overal duration: Laser therapy for 20 sessions (40 days)
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Intervention code [1]
284731
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Treatment: Devices
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Comparator / control treatment
Placebo
These sessions perform for the subjects in placebo group with turned-off device.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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tinnitus loudness assessed by pure tone audiometry
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Assessment method [1]
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Timepoint [1]
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immediately after completion of the 20 sessions, i.e. after 40 days and 3 months later
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Secondary outcome [1]
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tinnitus grading by tinnitus handicap inventory (THI)
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Assessment method [1]
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Timepoint [1]
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immediately after completion of the 20 sessions, i.e. after 40 days and 3 months later
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Eligibility
Key inclusion criteria
patients suffering from tinnitus and NIHL
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Minimum age
30
Years
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Maximum age
51
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
exposure to ototoxic drugs and substances
conductive hearing loss
retrocochlear and CNS disorders
psychotic disorders with auditory hallucination
contraindications for laser therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation was concealed by numbered containers
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
21/11/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
89
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Iran, Islamic Republic Of
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State/province [1]
4274
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Shahid Sadoughi University of Medical Sciences
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Address [1]
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Shahid Sadoughi University building, Bahonar square, Shahid sadoughi Blvd., Yazd, Iran
postal code:8913814389
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Country [1]
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Iran, Islamic Republic Of
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Primary sponsor type
University
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Name
Shahid Sadoughi University of Medical Sciences
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Address
Shahid Sadoughi University building, Bahonar square, Shahid sadoughi Blvd., Yazd, Iran
postal code:8913814389
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Country
Iran, Islamic Republic Of
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
284006
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Country [1]
284006
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Ethics committee of the research vice chancellor, Shahid sadoughi university of medical sciences
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Ethics committee address [1]
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Shahid Sadoughi University building, Bahonar square, Shahid sadoughi Blvd., Yazd, Iran
postal code:8913814389
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Ethics committee country [1]
287157
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Iran, Islamic Republic Of
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Date submitted for ethics approval [1]
287157
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20/07/2011
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Approval date [1]
287157
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25/08/2011
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Ethics approval number [1]
287157
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1563
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Summary
Brief summary
Tinnitus can be a possible complication of noise-induced hearing loss (NIHL) which is usually observed at frequencies equal to or higher than 3000Hz and one octave band higher than the frequency affected due to NIHL. A method which has been proposed for the treatment of tinnitus is low-level laser therapy (LLLT).
This study was designed to evaluate the effect of LLLT on tinnitus accompanied by NIHL.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Mohammad Hossein Davari
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Address
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Shahid Sadoughi University building, Bahonar square, Shahid sadoughi Blvd., Yazd, Iran
postal code:8913814389
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Country
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Iran, Islamic Republic Of
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Phone
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+98 351 6229193
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Fax
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+98 351 6229194
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mohammad Hossein Davari
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Address
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Shahid Sadoughi University building, Bahonar square, Shahid sadoughi Blvd., Yazd, Iran
postal code:8913814389
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Country
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Iran, Islamic Republic Of
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Phone
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+98 351 6229193
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Fax
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+98 351 6229194
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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