Skip to content

Trial of a tinnitus treatment platform based on "Personalised Sound Therapy"

Randomised Controlled Trial of a tinnitus treatment platform based on "Personalised Sound Therapy" on tinnitus severity compared to a popular tinnitus treatment mobile application.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000389808
Acronym
PSTT
Enrollment
99
Registered
2021-04-08
Start date
2021-04-14
Completion date
2021-11-24
Last updated
2023-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 partici

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.

Sponsors

The University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Participants unable or unwilling to use a Smartphone app. Persons without tinnitus.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026