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Digital thErapy For Improved tiNnitus carE Study (DEFINE): Protocol for a randomised controlled trial.

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The DEFINE trial compares the Oto app, a smartphone tinnitus therapy, to standard care. This study assesses if digital tinnitus treatment is as effective as in-person therapy for adults.

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Area of Science:

  • Audiology
  • Digital Health
  • Clinical Trials

Background:

  • Tinnitus affects 15% of the UK population, with limited access to standard treatments like Cognitive Behavioural Therapy (CBT).
  • Smartphone-delivered interventions offer a potential solution to improve access to tinnitus therapy.
  • The DEFINE trial investigates a novel digital approach to tinnitus management.

Purpose of the Study:

  • To evaluate the non-inferiority of the Oto app (smartphone-delivered tinnitus therapy) compared to standard one-to-one therapist-delivered tinnitus treatment.
  • To assess the effectiveness of digital tinnitus therapy in improving health-related quality of life.
  • To conduct a health economic evaluation of smartphone-delivered tinnitus therapy.

Main Methods:

  • An open-label, non-inferiority, randomised-controlled trial (RCT) with 198 adult participants.
  • Remote recruitment, intervention delivery, and assessments enabling UK-wide participation.
  • Participants were randomised 1:1 to either the Oto app or therapist-led therapy, with outcomes measured using the Tinnitus Functional Index (TFI) at 26 weeks.

Main Results:

  • Primary outcome: Change in Tinnitus Functional Index (TFI) total score at 26 weeks.
  • Secondary outcomes: Health-related quality of life, adverse events, and cost-utility analysis.
  • Data collection occurred at 4, 12, 26, and 52 weeks post-allocation.

Conclusions:

  • The study will determine if the Oto app is a viable and effective alternative to traditional tinnitus therapy.
  • Findings will inform the accessibility and cost-effectiveness of digital health solutions for tinnitus.
  • Results will be publicly disseminated, including a plain English summary.