ANZCTR - Registration

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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 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]

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

Condition category

Condition code

Ear

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]

Treatment: Devices

Intervention code [2]

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]

Change in Tinnitus Functional Index

Timepoint [1]

Baseline (4 weeks before device), immediately before device, 6 weeks and 12 weeks post device fitting

Secondary outcome [1]

Change in Tinnitus Severity Numerical Scale

Timepoint [1]

Baseline (4 weeks before device), immediately before device, 6 weeks and 12 weeks post device fitting

Secondary outcome [2]

Client Oriented Scale of Improvement scores indicating change.

Timepoint [2]

12 weeks post device fitting

Secondary outcome [3]

System Usability Scale rating.

Timepoint [3]

12 weeks post device fitting

Secondary outcome [4]

mHealth App Usability Questionnaire for Standalone mHealth Apps Used by Patients rating.

Timepoint [4]

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?

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

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Auckland Uniservices

Address [1]

Auckland UniServices Limited, Level 10, 49 Symonds St, Auckland 1010.

Country [1]

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]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Auckland Human Participants Ethics Committee

Ethics committee address [1]

The University of Auckland, Private Bag 92019, Victoria St West, Auckland 1142
PHONE: +64 9 3737 522

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

12/01/2021

Approval date [1]

18/01/2021

Ethics approval number [1]

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

A/Prof Grant D Searchfield

Address

The University of Auckland, Private Bag 92019, Victoria St West, Auckland 1142

Country

New Zealand

Phone

+64 9 3737 522

Fax

N/A

g.searchfield@auckland.ac.nz

Contact person for public queries

Name

Grant D Searchfield

Address

The University of Auckland, Private Bag 92019, Victoria St West, Auckland 1142

Country

New Zealand

Phone

+64 9 3737 522

Fax

N/A

g.searchfield@auckland.ac.nz

Contact person for scientific queries

Name

Grant D Searchfield

Address

The University of Auckland, Private Bag 92019, Victoria St West, Auckland 1142

Country

New Zealand

Phone

+64 9 3737 522

Fax

N/A

g.searchfield@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Data sovereignty for Maori data was not specifically unassigned

What supporting documents are/will be available?

Doc. No.	Type	Email
10502	Study protocol	g.searchfield@auckland.ac.nz
10503	Statistical analysis plan	g.searchfield@auckland.ac.nz
10505	Clinical study report	g.searchfield@auckland.ac.nz
10506	Ethical approval	g.searchfield@auckland.ac.nz

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A randomized single-blind controlled trial of a prototype digital polytherapeutic for tinnitus.	2022	https://dx.doi.org/10.3389/fneur.2022.958730

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically