Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000389808
Ethics application status
Approved
Date submitted
9/02/2021
Date registered
8/04/2021
Date last updated
13/06/2023
Date data sharing statement initially provided
8/04/2021
Date results information initially provided
13/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of a tinnitus treatment platform based on "Personalised Sound Therapy"
Scientific title
Randomised Controlled Trial of a tinnitus treatment platform based on "Personalised Sound Therapy" on tinnitus severity compared to a popular tinnitus treatment mobile application.
Secondary ID [1] 303255 0
University of Auckland Project number: 5001137
Universal Trial Number (UTN)
U1111-1264-7942
Trial acronym
PSTT
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Tinnitus 320434 0
Condition category
Condition code
Ear 318331 318331 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name:
Personalised Sound Therapy.

Materials:
Participants cell phone, custom application (app) for Apple and Android, calibrated Bluetooth bone conduction headphones, Bluetooth neck worn stereo speaker, clinician dashboard software.

The app has three different modes – passive listening (Relief, Relax & Retraining), active listening (game-based treatment) and counselling. The control app is a popular self-help tinnitus app that lacks the personalisation of the treatment app. The participants will be asked to use for a minimum of 2 hours per day for 12 weeks. The instructions per participant will vary as part of a goal setting and needs assessment process. Participants requiring "relief" may use "relief" sounds often until some control over tinnitus is achieved, those for whom relaxation was an important goal may use when stress, and so on. Relief sounds have high interaction with tinnitus creating masking (an example is white noise) while relaxation sounds have positive emotion affect associated with calm situations (an example is a gentle waterfall). The exact sounds are selected from a library of sounds according to participant preference. Retraining sounds are more complex nature sounds with multiple sounds that participants are instructed to focus attention on, enabling retraining of attention away from tinnitus. A training program is provided in which a variety of different 'everyday' sounds at different frequencies that participants are trained to attend to, and respond, feedback is provided on correct/incorrect identification. This aims to motivate the participant to complete listening tasks. The number of hours and type of sound/counselling will be personalised to these needs. The general recommendations for an average anticipated participant is the following: "to use relief sounds in morning, relaxation sounds in afternoon (as needed) and training – for 30 mins between 10:00-14:00 h and 16:00-22:00 h (a total of 1 hr per day). Depending on needs and preferences recommendations may change during the trial, but with 2 hrs minimum target. Compliance will be measured through the cloud based interface with the app that creates a catalog of use. Further monitoring will be completed by the researcher at assessment times through email and sms text messages.

The app is a currently only available for study participants. The outcome of this trial will determine, to some extent, if and how the app will be made more widely available.

The patient undergoes a clinic-based psychoacoustic and psychometric hearing and tinnitus assessment

The clinician assesses and record the patient’s condition and set treatment goals and priorities.

A customised profile is established using the clinician dashboard and fitting algorithms according to the patients’ needs and tinnitus assessment. The frequency response of relief sounds are tailored to the individuals minimum masking levels, and the perceived position in space is modified to the most effective position relative to where the tinnitus is heard. Recommendations and selection of sounds available on the app are chosen based on personal preference. Using the clinician dashboard, the treatment modules are customised in the manner described and uploaded to the patient’s smartphone. 
Intervention code [1] 319558 0
Treatment: Devices
Intervention code [2] 319942 0
Treatment: Other
Comparator / control treatment
Participants cell phone, application (app) called white noise, available for (app) for Apple and Android. Participants own preferred earphones or selection from Apple and Panasonic earbuds.

The app "White Noise" is available from Android and Apple app stores.

The participants will be instructed to use as needed for tinnitus relief for a minimum of 2 hours per day for 12 weeks.

The participants will have a range of built in sounds that they will be able to access on the basis of personal preference. The clinician will not guide or customise the control app.

The app does not provide analytic information. Monitoring will be completed by the researcher at assessment times through email and sms text messages.
Control group
Active

Outcomes
Primary outcome [1] 326476 0
Change in Tinnitus Functional Index
Timepoint [1] 326476 0
Baseline (4 weeks before device), immediately before device, 6 weeks and 12 weeks post device fitting
Secondary outcome [1] 391625 0
Change in Tinnitus Severity Numerical Scale
Timepoint [1] 391625 0
Baseline (4 weeks before device), immediately before device, 6 weeks and 12 weeks post device fitting
Secondary outcome [2] 391626 0
Client Oriented Scale of Improvement scores indicating change.
Timepoint [2] 391626 0
12 weeks post device fitting
Secondary outcome [3] 391627 0
System Usability Scale rating.
Timepoint [3] 391627 0
12 weeks post device fitting
Secondary outcome [4] 391628 0
mHealth App Usability Questionnaire for Standalone mHealth Apps Used by Patients rating.
Timepoint [4] 391628 0
12 weeks post device fitting

Eligibility
Key inclusion criteria
.Adults with continuous chronic tinnitus (> 6 months, Tinnitus Functional Index, TFI > 40 [Moderate to high Tinnitus handicap] no prior treatment history, loud sound does not worsen tinnitus, stress makes tinnitus worse) will be recruited from the general tinnitus population of Auckland.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants unable or unwilling to use a Smartphone app.
Persons without tinnitus.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation with stratification for TFI score and age
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis calculation was undertaken to determine the sample size for a repeated measures ANOVA with two groups and 4 repeated measures. For an effect size of 0.4 (small-moderate) an alpha of 0.05 and power 0.9 a sample size of 90 was calculated. Recruiting 100 participants (50 per group) will allow for a dropout rate of 10%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/04/2021
Actual
14/04/2021
Date of last participant enrolment
Anticipated
23/08/2021
Actual
24/11/2021
Date of last data collection
Anticipated
1/11/2021
Actual
19/03/2022
Sample size
Target
100
Accrual to date
Final
99
Recruitment outside Australia
Country [1] 23443 0
New Zealand
State/province [1] 23443 0
Auckland

Funding & Sponsors
Funding source category [1] 307664 0
Other Collaborative groups
Name [1] 307664 0
Auckland Uniservices
Country [1] 307664 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland, Private Bag 92019, Victoria St West, Auckland 1142
PHONE: +64 9 3737 522
Country
New Zealand
Secondary sponsor category [1] 308517 0
None
Name [1] 308517 0
N/A
Address [1] 308517 0
N/A
Country [1] 308517 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307702 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 307702 0
The University of Auckland, Private Bag 92019, Victoria St West, Auckland 1142
PHONE: +64 9 3737 522
Ethics committee country [1] 307702 0
New Zealand
Date submitted for ethics approval [1] 307702 0
12/01/2021
Approval date [1] 307702 0
18/01/2021
Ethics approval number [1] 307702 0
UAHPEC18966

Summary
Brief summary
This project will test the hypothesis that: "A Precision Sound Therapy" based Behavioural Intervention Technology (BIT) application (app) will provide superior tinnitus therapy outcomes than a self-help sound therapy app. The BIT is based on the concept of, personalised health care, developed here to address the heterogeneity of tinnitus and its
response to various therapies. Using the BIT the clinician has partial control over the overall system and can remotely enable or disable functionalities, modes and content of the patients app. So, the clinician can create, personalise and adjust the solution to the needed treatment of each patient. As an example, the clinician can give or setup different assessments to the patient on a daily, weekly, monthly base depending on their
condition and needs. The app has three different modes – passive listening (Relief, Relax & Retraining), active listening (game-based treatment) and counselling. The control app is a popular self-help tinnitus app that lacks the personalisation of the treatment app. The outcomes of the study will help determine what further trials and/or modifications of the app are needed before it is made available as a tinnitus therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108198 0
A/Prof Grant D Searchfield
Address 108198 0
The University of Auckland, Private Bag 92019, Victoria St West, Auckland 1142
Country 108198 0
New Zealand
Phone 108198 0
+64 9 3737 522
Fax 108198 0
N/A
Email 108198 0
[email protected]
Contact person for public queries
Name 108199 0
A/Prof Grant D Searchfield
Address 108199 0
The University of Auckland, Private Bag 92019, Victoria St West, Auckland 1142
Country 108199 0
New Zealand
Phone 108199 0
+64 9 3737 522
Fax 108199 0
N/A
Email 108199 0
[email protected]
Contact person for scientific queries
Name 108200 0
A/Prof Grant D Searchfield
Address 108200 0
The University of Auckland, Private Bag 92019, Victoria St West, Auckland 1142
Country 108200 0
New Zealand
Phone 108200 0
+64 9 3737 522
Fax 108200 0
N/A
Email 108200 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data sovereignty for Maori data was not specifically unassigned


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10502Study protocol  [email protected]
10503Statistical analysis plan  [email protected]
10505Clinical study report  [email protected]
10506Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomized single-blind controlled trial of a prototype digital polytherapeutic for tinnitus.2022https://dx.doi.org/10.3389/fneur.2022.958730
N.B. These documents automatically identified may not have been verified by the study sponsor.