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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
Scientific title
Low-level laser therapy for improvement of tinnitus associated with NIHL among workers exposed to loud noise
Secondary ID [1] 280365 0
Nil
Universal Trial Number (UTN)
U1111-1130-1023
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tinnitus 286338 0
Noise-induced hearing loss 286358 0
Condition category
Condition code
Ear 286582 286582 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 284731 0
Treatment: Devices
Comparator / control treatment
Placebo
These sessions perform for the subjects in placebo group with turned-off device.
Control group
Placebo

Outcomes
Primary outcome [1] 287004 0
tinnitus loudness assessed by pure tone audiometry
Timepoint [1] 287004 0
immediately after completion of the 20 sessions, i.e. after 40 days and 3 months later
Secondary outcome [1] 297183 0
tinnitus grading by tinnitus handicap inventory (THI)
Timepoint [1] 297183 0
immediately after completion of the 20 sessions, i.e. after 40 days and 3 months later

Eligibility
Key inclusion criteria
patients suffering from tinnitus and NIHL
Minimum age
30 Years
Maximum age
51 Years
Gender
Males
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation was concealed by numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4274 0
Iran, Islamic Republic Of
State/province [1] 4274 0

Funding & Sponsors
Funding source category [1] 285141 0
University
Name [1] 285141 0
Shahid Sadoughi University of Medical Sciences
Address [1] 285141 0
Shahid Sadoughi University building, Bahonar square, Shahid sadoughi Blvd., Yazd, Iran
postal code:8913814389
Country [1] 285141 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shahid Sadoughi University of Medical Sciences
Address
Shahid Sadoughi University building, Bahonar square, Shahid sadoughi Blvd., Yazd, Iran
postal code:8913814389
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 284006 0
None
Name [1] 284006 0
Address [1] 284006 0
Country [1] 284006 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287157 0
Ethics committee of the research vice chancellor, Shahid sadoughi university of medical sciences
Ethics committee address [1] 287157 0
Shahid Sadoughi University building, Bahonar square, Shahid sadoughi Blvd., Yazd, Iran
postal code:8913814389
Ethics committee country [1] 287157 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 287157 0
20/07/2011
Approval date [1] 287157 0
25/08/2011
Ethics approval number [1] 287157 0
1563

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34094 0
Address 34094 0
Country 34094 0
Phone 34094 0
Fax 34094 0
Email 34094 0
Contact person for public queries
Name 17341 0
Mohammad Hossein Davari
Address 17341 0
Shahid Sadoughi University building, Bahonar square, Shahid sadoughi Blvd., Yazd, Iran
postal code:8913814389
Country 17341 0
Iran, Islamic Republic Of
Phone 17341 0
+98 351 6229193
Fax 17341 0
+98 351 6229194
Email 17341 0
drmhdavari@gmail.com
Contact person for scientific queries
Name 8269 0
Mohammad Hossein Davari
Address 8269 0
Shahid Sadoughi University building, Bahonar square, Shahid sadoughi Blvd., Yazd, Iran
postal code:8913814389
Country 8269 0
Iran, Islamic Republic Of
Phone 8269 0
+98 351 6229193
Fax 8269 0
+98 351 6229194
Email 8269 0
drmhdavari@gmail.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary