Trial of a tinnitus treatment platform based on Personalised Sound Therapy

Not Applicable

Completed

• Conditions: Tinnitus; Ear - Other ear disorders

• Registration Number: ACTRN12621000389808
• Lead Sponsor: The University of Auckland

Brief Summary

This randomized single-blind controlled trial tested the hypothesis that a prototype digital therapeutic developed to provide goal-based counseling with personalized passive and active game-based sound therapy would provide superior tinnitus outcomes, and similar usability, to a popular passive sound therapy app over a 12 week trial period. The digital therapeutic (USL) consisted of an app for iPhone or Android smartphone, Bluetooth bone conduction headphones, neck pillow speaker, and a cloud-based clinician dashboard to enable messaging and app personalization. The control app was a popular self-help passive sound therapy app called White Noise Lite (WN). The USL group demonstrated a higher proportion of responders than the WN group. The usability of the USL therapeutic was similar to the established WN app. The digital polytherapeutic demonstrated significant benefit for tinnitus reduction supporting further development.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-08
• Study Completion: 2022-03-19
• Last Update Posted: 21 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Tinnitus Functional Index[Baseline (4 weeks before device), immediately before device, 6 weeks and 12 weeks post device fitting]

Secondary Outcome Measures

Name	Time	Method
Change in Tinnitus Severity Numerical Scale[Baseline (4 weeks before device), immediately before device, 6 weeks and 12 weeks post device fitting];Client Oriented Scale of Improvement scores indicating change.[12 weeks post device fitting];System Usability Scale rating.[12 weeks post device fitting];mHealth App Usability Questionnaire for Standalone mHealth Apps Used by Patients rating.[12 weeks post device fitting]