Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000338460p
Ethics application status
Submitted, not yet approved
Date submitted
29/03/2025
Date registered
22/04/2025
Date last updated
22/04/2025
Date data sharing statement initially provided
22/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of a digital smartphone-based personalised tinnitus therapy.
Scientific title
The Triple T tinnitus trial. A three-arm waitlist-controlled trial of the QCore tinnitus therapy system, its effect on the Tinnitus Functional Index
Secondary ID [1] 313365 0
Nil none
Universal Trial Number (UTN)
Trial acronym
TTT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tinnitus 335721 0
Condition category
Condition code
Ear 332287 332287 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a trial of a smartphone-based tinnitus therapy system that provides a 90-day program combining sound therapy and listening exercises. If participants meet the study criteria they will complete some questionnaires on an online form. Throughout the study which is 330 days long participants will be asked to repeat these questionnaires. After a period of waiting in which we measure participants' tinnitus several times for repeatability a new therapy will be trialed after EEG measures. The treatment is based on participants' treatment goals and an assessment of your tinnitus sound. The researcher will customize settings using a computer and download a software “app” to participants' phones. Participants will be provided with instructions on how to use the software and be provided open-ear earphones and a speaker to play sounds through. During 90 days of use we will ask participants to complete the tinnitus questionnaires several times. After 90 days of therapy is finished, we will ask them to complete the tinnitus questionnaires several times. When the trial is finish participants can keep the software and the earphones and speaker for free.

DEVICE DESCRIPTION
The QCore is a non-invasive solution for tinnitus sufferers, combining advanced technology with personalized care. The system consists of 1. Clinician dashboard, 2. Smart Phone software (iOS, Android), and 3. Bluetooth open-ear earphones.


Clinician dashboard
The clinician dashboard allows each clinician to record client demographics, test tinnitus characteristics and transfer information to the client’s smartphone software. The dashboard enables viewing of real-time tinnitus client data and progress. A customised profile is established based on participant’s preferences and goals using a goal-assessment tool (Client Oriented Scale of Improvement in Tinnitus, COSIT). Five goals are placed in order of priority and an algorithm prescribes a 1-hour per day, 90-day treatment, weighted to individual needs from three different therapy modes: 1. Relief, 2. Relaxation, 3. Retraining. Narrow-band noise minimum masking levels (MMLs) are measured. An algorithm is applied to the MMLs to create a custom Threshold Adjusted Noise (TAN) profile that can be applied to therapeutic sounds to improve masker efficacy.

Participant Smartphone software
A unique code enables the client to download the necessary software to their iOS or Android phone. The QCore software guides the client to customize their therapy, and to monitor progress. The QCore software allocates participants time to three different therapy modes 1. Relief, 2. Relaxation, and 3. Retraining based on their COSIT priorities. If the COSIT priorities change (based on the participant’s selection on the software) weighting of time to the 3 modes is adjusted. The therapeutic components within each mode consist of 1. Counselling, 2. Passive Sound, and 3. Active listening:

1. Counselling: Automated periodic text-based counselling to improve self-management behaviours and achieve better therapy adherence. The text messages are brief explanatory messages relating to the task to be undertaken or motivational messages encouraging ongoing engagement in therapy. The messages appear intermittently alongside the therapy tasks. Recorded guided abbreviated progressive relaxation, mindfulness, and deep breathing exercises are available as part of the relax mode.
2. Passive sound therapy: The tracks are selected from a library of sounds according to participant preference and goals. (i) Relief sounds have high interaction with tinnitus, creating masking. Personalized sounds where the frequency response is tailored to the individuals minimum masking levels and perceived position in space are included. (ii) Relaxation sounds have positive emotion affect associated with calm situations (e.g., gentle waterfall). (iii) Retraining sounds are more complex nature sounds with multiple sound objects and participants will be instructed to focus attention on these sounds, enabling retraining of attention away from tinnitus.
3. Active listening. This consists of a calibration task that gives the player agency over a sound resembling their tinnitus and games that present distractor sounds matching the location and frequency of tinnitus and target sounds remote from the tinnitus match. Participants are rewarded through points scored in responding to target (non-tinnitus sounds). The training games are based on the Auditory Object Identification and Localization (AOIL) paradigm.

Hardware
The hardware consists of Cleer Arc II Bluetooth open-ear earphones.

Intended Use
QCore is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older). This includes hearing aids users. This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

Principles of Operation.
Following a 20-min period of active listening by the clinician, the participants needs and goals with therapy will be ascertained using the Client Oriented Scale of Improvement in Tinnitus (COSIT) as part of the QCore therapy. The COSIT is a questionnaire, incorporated into the QCore system, in which the participant lists up to five improvement goals they hope to realize with the therapy, that they then rank. Pure tone audiometry will be conducted in a sound treated room (ISO 8253–1:2010) and will employ the modified Hughson-Westlake procedure. Tinnitus psychoacoustic matching (tinnitus frequency, loudness per ear and location) will be obtained using the QCore therapy system. The participant will be prescribed the QCore therapy and be provided with instructions and take-home materials. Subsequent assessments will be undertaken remotely. Daily use will be logged to monitor adherence, recording time and module use.
The system will be used by each participant, at home, according to the following protocol:
Participants will be prescribed a minimum total of 1-hour per day, 90-day treatment. The 1 hour of use can be distributed across a day. Participants will be guided by the software as to which tasks to undertake.

Repeated outcome measures will be obtained at nine time points for treatment groups: 1. Baseline 1 (Recruitment screening), 2. Baseline 2 (therapy provision 30 days following Baseline 1), 3. Treatment 1 following 30 days with therapy, 4. Treatment 2 following 60 days with therapy, 5. Treatment 3 following 90 days with therapy, 6. Post therapy 1 (30 days following therapy), 7. Post therapy 2 (60 days following therapy), 8. Post therapy 3 (90 days following therapy = 210 days following Baseline 1), 9. Trial end final post treatment measure (330 days following Baseline 1).

Waitlist Control group schedule:
Repeated outcome measures will be obtained at nine time points for the waitlist group: 1. Baseline 1 (Recruitment screening), 2. Baseline 2 (30 days following Baseline 1), 3. Baseline 3 (60 days following Baseline 2), 4. Treatment 1 (following 30 days with therapy), 5. Treatment 2 (following 60 days with therapy), 6. Treatment 3 (following 90 days with therapy), 7. Trial end final post treatment measure (330 days following Baseline 1).

Baseline
At baseline participants will be assigned a unique identifier code so data can be analysed in a deidentified manner. Participants will be provided with a link to online questionnaires coded, stored, and collated using the University's REDCap account. The system operates in accordance with safe design and software maintenance standards for medical software.
At screening participants will complete: a comprehensive case history [Tinnitus Sample Case History Questionnaire, TSCHQ].
During baseline, and at each assessment point, participants will complete the TFI (a standard assessment questionnaire), and the Tinnitus Magnitude Index (a short measure aiding to quantify the tinnitus perception separate from reaction). The TFI will serve as the primary endpoint measure in this trial.
Intervention code [1] 329945 0
Treatment: Devices
Comparator / control treatment
Waitlist control and between site comparison. The waitlist control will receive therapy after the intervention groups complete 90 days of therapy (intervention) this couple with baseline equates to 120 days following recruitment.
Control group
Active

Outcomes
Primary outcome [1] 339859 0
Tinnitus severity (function effects of tinnitus on life) measured by a standard tinnitus question and secondary measures to provide additional evidence of effects
Timepoint [1] 339859 0
Baseline and following 90 days of therapy.
Secondary outcome [1] 441671 0
Tinnitus effect on individual goals (personalized, will vary from individual to individual, as open ended questionnaire, goals could be loudness, annoyance...quality of life etc.)
Timepoint [1] 441671 0
Baseline and 90 days following therapy.
Secondary outcome [2] 441672 0
Tinnitus related brain activity measured using electrophysiological measures of the resting brain state.
Timepoint [2] 441672 0
Baseline and 90 days following therapy.

Eligibility
Key inclusion criteria
1. Participant aged 18 to 85 years, inclusive.
2. Participant can provide written informed consent.
3. Participant has chronic tinnitus (> 3 months) and is consistently aware of their tinnitus throughout much of the waking day.
4. A maximum of a moderate degree of hearing loss.
5. Hearing aid users will be eligible for the study but needed to be able to hear therapy sounds through earphones unaided.
6. Participants will be smartphone users, be familiar with smartphone apps, and own active Android or Apple phones.
7. Individuals prescribed medications, including for anxiety or depression, will be eligible.
8. Participants will be asked to refrain from starting any new tinnitus treatments during the trial.
9. Participant has an overall score of > 30 on the Tinnitus Functional Index (TFI) at the Screening visit.
10. Participant is willing to comply with the protocol and attend all study visits and online assessments.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant has pulsatile tinnitus, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumour or stroke.
2. Participant has active middle ear disease, including but not limited to chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma, Meniere’s disease, or retro-cochlear schwannoma.
3. Participant has recently (< 1 month of Screening) initiated new treatment for tinnitus (e.g. noise generators, hearing aids, behavioural therapy); only stable tinnitus treatments are allowed during the study.
4. Participant is not able to accurately identify and report their tinnitus.
5. Participant is receiving any ongoing therapy known as potentially tinnitus-inducing
6. Participant has severe or untreated depression or anxiety that, in the investigator’s opinion, would likely reduce the safety of study participation.
7. Participant has any other clinically significant illness, medical condition or medical history that, in the investigator’s opinion, would likely reduce the safety of study participation or prohibit the participant from participating in the study at Screening or at the time of randomization.

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)
Central randomisation will be done by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation at the Auckland site. Automatic allocation to intervention at the Christchurch site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A detailed statistical plan is outlined in the attached protocol.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
30/03/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 26721 0
New Zealand
State/province [1] 26721 0

Funding & Sponsors
Funding source category [1] 317805 0
Commercial sector/Industry
Name [1] 317805 0
TrueSilence Therapeutics Inc
Country [1] 317805 0
United States of America
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 320134 0
None
Name [1] 320134 0
Address [1] 320134 0
Country [1] 320134 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316488 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 316488 0
Ethics committee country [1] 316488 0
New Zealand
Date submitted for ethics approval [1] 316488 0
15/04/2025
Approval date [1] 316488 0
Ethics approval number [1] 316488 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138058 0
Prof Grant D Searchfield
Address 138058 0
The University of Auckland, 34 Princes Street, Auckland Central, Auckland 1010
Country 138058 0
New Zealand
Phone 138058 0
+64 21 877 949
Fax 138058 0
Email 138058 0
[email protected]
Contact person for public queries
Name 138059 0
Grant D Searchfield
Address 138059 0
The University of Auckland, 34 Princes Street, Auckland Central, Auckland 1010
Country 138059 0
New Zealand
Phone 138059 0
+64 21 877 949
Fax 138059 0
Email 138059 0
[email protected]
Contact person for scientific queries
Name 138060 0
Grant D Searchfield
Address 138060 0
The University of Auckland, 34 Princes Street, Auckland Central, Auckland 1010
Country 138060 0
New Zealand
Phone 138060 0
+64 21 877 949
Fax 138060 0
Email 138060 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Commercially sensitive data



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.