Please note that IPD sharing statement and summary results sections will be added to the ANZCTR form in the coming months in order to comply with the updated WHO Trial Registration Data Set.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Trial ID
ACTRN12613001122741
Ethics application status
Approved
Date submitted
1/10/2013
Date registered
9/10/2013
Date last updated
9/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison between Tinnitus Retraining Therapy (TRT) and Tinnitus Adaptation Level Therapy (TALT) for the treatment of tinnitus
Scientific title
An investigation of the benefit of adaptation counselling and spatial sound therapy versus tinnitus retraining therapy and bilateral masking for the alleviation of distress in tinnitus patients
Secondary ID [1] 283330 0
Nil known
Universal Trial Number (UTN)
U1111-1148-5703
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tinnitus 290224 0
Anxiety 290244 0
Hearing impairment 290245 0
Condition category
Condition code
Ear 290616 290616 0 0
Deafness
Mental Health 290635 290635 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All subjects will receive a single 1.5 hour counselling session at the beginning of each phase of the trial. Counselling will be conducted at the beginning of the trial and again 8 weeks later, following the 6 week trial of the hearing device and 2 week wash out period. The participants will be divided into two groups with group one receiving counselling based on Tinnitus Adaptation Level therapy (TALT) and the other receiving directive counselling as specified by tinnitus retraining therapy (TRT). Counselling will be individual face to face.
The effect of this initial counselling will be evaluated 1 week following counselling, using scales of tinnitus severity (TSNS), and a depression index (HADS).
Subjects will then be fitted with binaural prototype GN Resound hearing devices, capable of delivering masking noise in 2D and 3D. Those subjects who received the adaptation level therapy will be fitted with the hearing devices matched to the location of their tinnitus site. Those that received the TRT counselling will have the hearing devices set to deliver sound to both ears set to the mixing point as defined for TRT by Jastreboff.
At 5 weeks fitting, measures of tinnitus annoyance will be measured using the TFI, TSNS, THQ, HHI, CGI. This will be followed by a minimum 2 week wash out period. The subjects will then be crossed over so that those who received TRT and 2D masking will now receive and TALT and 3D masking and those who received TALT and 3D will now receive TRT and 2D.
Evaluation of the benefit of the devices and counselling will again be made at one week following counselling and 5 weeks post fitting.
All the participants will be fited bilaterally with GN Reound open-fit hearing devices at a separate appointment following the assessment and counselling session (irrespective of which group they were in). A modified DSL(I/O) v5.0 will be used as the amplification perscription target and the fitting will be adjusted according to participants comfort and preference. Care, maintenance and use of the hearing devices will be explained to participants during the hearing device fitting session and they will be reccomended to use the devices in a variety of everyday listening situations. Participants will be told to contact the researcher if they require any further assistance before the next follow up, which will be in 2 weeks.
Intervention code [1] 288055 0
Rehabilitation
Intervention code [2] 288070 0
Treatment: Devices
Comparator / control treatment
The proposed research is to evaluate he effectiveness of the new sound therapy and counselling concept (TALT) against the standard control treatment, TRT
Control group
Active

Outcomes
Primary outcome [1] 290628 0
Tinnitus Functional Index
Timepoint [1] 290628 0
Completed at 6 weeks following each counselling session and 5 weeks following the hearing device fitting. The counselling combined with the device fiting is the intervention.
Primary outcome [2] 290630 0
The advantage of TALT versus TRT the following tests of tinnitus adaptation and hearing device benefit;
TFI- Tinnitus functional index
TSNS- Tinnitus Severity numeric scale
CGI- Clinical Global improvement scale
Timepoint [2] 290630 0
Completed at 6 weeks following each counselling session and 5 weeks following the hearing device fitting. The counselling combined with the device fiting is the intervention.
Primary outcome [3] 290646 0
Measure of psycoacoustic improvement using software to measure tinnitus characterisitcs, e.g. pitch, loudness, minimum masking level.
Timepoint [3] 290646 0
Completed at 6 weeks following each counselling session and 5 weeks following the hearing device fitting. The counselling combined with the device fiting is the intervention.
Secondary outcome [1] 304934 0
Hearing device benefit will be ascertained using a modified DSL(I/O) vs5.0 as the amplification perscription target and the fitting will be adjusted according to participant's comfort and preference. The amount of gain provided will be measured using an insertion gain procedure to match the device gain to the the DSL target
Timepoint [1] 304934 0
Hearing deivce benefit will be ascertianed 5 weeks following fitting by means of the HHI- hearing handicap index and the CGI- measure of global improvement

Eligibility
Key inclusion criteria
mild-moderate sensorineural hearing loss in the fitting range of the test devices. They will have moderate-severe (minimum score of 25 on the TFI) chronic (duration greater than 6 months) tinnitus with non-center clearly identified localized tinnitus.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Normal hearing, severe hearing loss
No or mild tinnitus
Hyperacusis
Acute tinnitus (< 6 months)
Previous users of sound generators or combination devices
Undergoing other treatment for tinnitus or anxiety/depression

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A linear Mixed Model analysis using SPSS software will be undertaken on the data. Based on a power analysis a total of 10 patients will enter this two-treatment crossover study. The probability is 80 percent that the study will detect a treatment difference at a two-sided 0.05 significance level, if the true difference between treatments is 7 TFI units. This is based on the assumption that the within-patient standard deviation of the response variable is 5, which is based on previous evaluations of test-retest variance of the TFI in a similar participant population.

Recruitment
Recruitment status
Not yet recruiting
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] 5454 0
New Zealand
State/province [1] 5454 0
Auckland

Funding & Sponsors
Funding source category [1] 288065 0
Commercial sector/Industry
Name [1] 288065 0
G N Resound
Address [1] 288065 0
GN ReSound A/S Lautrupbjerg 7 Ballerup, 2750
Country [1] 288065 0
Denmark
Primary sponsor type
University
Name
University of Auckland
Address
Morrin Street
St John
Auckland 1072
Country
New Zealand
Secondary sponsor category [1] 286787 0
Individual
Name [1] 286787 0
Grant Searchfield
Address [1] 286787 0
University of Auckland
Morrin Street
St John
Auckland 1072
Country [1] 286787 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289990 0
University of Auckland human participant’s ethics committee
Ethics committee address [1] 289990 0
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Ethics committee country [1] 289990 0
New Zealand
Date submitted for ethics approval [1] 289990 0
Approval date [1] 289990 0
17/12/2012
Ethics approval number [1] 289990 0
6192

Summary
Brief summary
Determine the effectiveness of the new 3D sound therapy concept relative to existing standard sound therapy for tinnitus treatment
Determine the instrument setting preferences and preferences for Resound 3D hearing devices
Determine the effectiveness of 3D assessment and tinnitus adaptation counselling versus TRT directive counselling and maskimg at mixing point as prescribed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43342 0
Dr Grant Searchfield
Address 43342 0
University of Auckland
Level 3, Bldg. 730, School of Population Health
Faculty of Medical and Health Sciences
261 Morrin Road
Glen Innes
Auckland 1072
Country 43342 0
New Zealand
Phone 43342 0
+64 923 86316
Fax 43342 0
Email 43342 0
g.searchfield@auckland.ac.nz
Contact person for public queries
Name 43343 0
Ms Shirley-Anne Hodgson
Address 43343 0
University of Auckland
Level 3, Bldg. 730, School of Population Health
Faculty of Medical and Health Sciences
261 Morrin Road
Glen Innes
Auckland 1072
Country 43343 0
New Zealand
Phone 43343 0
+64 923 86542
Fax 43343 0
Email 43343 0
s.hodgson@auckland.ac.nz
Contact person for scientific queries
Name 43344 0
Dr Grant Searchfield
Address 43344 0
University of Auckland
University of Auckland
Level 3, Bldg. 730, School of Population Health
Faculty of Medical and Health Sciences
261 Morrin Road
Glen Innes
Auckland 1072
Country 43344 0
New Zealand
Phone 43344 0
+64 923 86316
Fax 43344 0
Email 43344 0
g.searchfield@auckland.ac.nz