Multimodality Smartphone App Delivered Therapy for Tinnitus – A Protocol for a Randomised Controlled Trial

Background: Tinnitus is a poorly understood symptom that is common with some patients experiencing severe impacts on their quality of life. The current pathway for patients involves being reviewed by an ear, nose and throat surgeon followed by referral to audiologists who are understandably inundated. Technology is ever advancing and in reducing face to face contact to limit pathogen transmission, smartphone applications may become a solution. Aims/Objectives: To evaluate the clinical effectiveness of the Oto smartphone app as an alternative to the current standard of care provided on the NHS when looking at tinnitus burden, insomnia severity and quality of life. Material and Methods: This randomised controlled trial is an open-label, non-inferiority and prospective two arm study. 160 adult participants will be recruited from our secondary care clinics. The patients will be identified based on screening for eligibility criteria. They will undergo randomisation 1:1 to either the Oto application or tinnitus retraining therapy arm. Outcomes measured will use questionnaires that look at tinnitus burden (Tinnitus Functional Index), insomnia severity (Insomnia Severity Index) and quality of life (World Health Organization Quality-of-Life Scale) at baseline, 1 month, 3 months and 6 months post intervention. Ethics and Dissemination: The trial has already been granted a favourable ethical outcome as per the UK Health Research Authority Bloomsbury Committee (REC:23/LO/0896). Trial results will be made available to the general public through formal publication and dissemination.