Objective assessment of a digital therapeutic for adults with tinnitus

The aim of this study is to examine whether the effects of using a new treatment for tinnitus management can be objectively measured. The new treatment is a digital therapeutic for tinnitus management called Oto which is accessed via a smartphone app. To do this, two groups of people with tinnitus – one group consistently using the Oto app for three months (intervention arm) and another not using the app at all (control arm) – will have assessments taken at two timepoints 3-3.5 months apart. Oto is a digital therapeutic combining cognitive behavioural therapy (CBT) with mindfulness, patient education and app-delivered physical relaxation exercises and gentle stretches designed to help users manage bodily tension that can accompany tinnitus-related stress. These may include simple guided neck, shoulder, jaw or upper-body stretches, breathing-based relaxation, and exercises aimed at releasing muscle tension. These are not delivered as formal physiotherapy and are not individually prescribed by a physiotherapist. They are provided within the Oto app as recorded self-guided audio/digital content. Oto’s programme offers a series of therapy sessions, where the user listens to recorded audio content that takes them through education, cognitive exercise or a tinnitus-specific meditation. Users work their way through progressive modules at their own pace using a spiral curriculum, where the sessions build on techniques and exercises learned in previous sessions. Users can personalise their therapy by listening to additional modules and sounds from the sound library. Supplementary modules and tools accessible through the app may cover areas such as understanding tinnitus, habituation, changing unhelpful responses to tinnitus, managing tinnitus-related distress, relaxation, sleep, stress, concentration/focus, mindfulness, and coping with tinnitus spikes. The app also includes a sound library with sound therapy options and soundscapes, such as nature sounds or white/ambient noise, which users may use to support relaxation, focus, sleep and habituation. These resources have not been developed specifically for this study. They are pre-existing Oto app resources developed by Oto Health Ltd and available within the Oto digital therapeutic. CBT techniques that Oto may teach include: -Attention redirection - deliberately shifting focus away from the tinnitus and toward other sounds or activities. -Behavioural experiments -testing beliefs such as “I can’t concentrate when my tinnitus is loud” by trying a task and observing what happens. -Relaxation and mindfulness exercises - learning to notice tinnitus without reacting emotionally to it. -Habituation training - teaching the brain to treat tinnitus as an unimportant background sound. At-home use of the Oto app will be supported via three online meetings with an audiologist to assist onboarding, goal-setting and engagement with the programme.. These online sessions will be interspaced throughout the 3-month use of the app. The Oto app will record engagement with the app by participants such as frequency of use, overall duration of use and number of modules completed. The audiologist will access these engagement analytics and will discuss them with participants during the online sessions. Timeline of participation is described below, 1) Baseline visit (1-2 hours) (Day 0): Participants will be asked to complete an initial visit to get a baseline assessment. Assessments include: functional near-infrared spectroscopy (fNIRS) imaging, pure tone audiometry and questionnaires about tinnitus, stress and mental health. After the baseline visit, participants can self-select if they would like to be involved in the intervention group or the control group. 2) Intervention group only: Initial online meeting (90 mins) (up to 7 days from baseline visit): Participants in the intervention group will be booked into an online meeting with the study audiologist within one week of their baseline visit. During this meeting, participants will be asked to download and install the Oto app. The audiologist will support with setup and onboarding. They will also discuss with participants how often they should use the app. This can vary depending on each participant’s CBT program goals (e.g., complete 20 sessions within the next 4 weeks). Goals discussed will be recorded by the audiologist in a study-specific database. Usage of the app depends on goals discussed with the audiologist but could be as often as once a day at most for the duration of the study. Engagement with the Oto app by participants will be recorded in-app, including frequency of use, overall duration of use and number of modules completed. The audiologist will not deliver tinnitus counselling and will only support with the use of the app. 3) Intervention group only: 2nd online meeting (20-60 mins) (1 month after starting use of the Oto app): Participants will be asked to attend a 2nd online meeting with the study audiologist. During this meeting, the audiologist will review the participant’s use of the app, how the participant is tracking against the goals set during the first online meeting (e.g., how many sessions have they completed compared to the goal agreed upon 4 weeks ago), help problem-solve barriers if goals were unmet, and set new goals for the remaining duration of the study. New goals will again be recorded by the study audiologist. The participant is also free to ask any app-use questions they may have. 4) Intervention group only: 3rd online meeting (20-60 mins) (3 months after starting use of the Oto app): Participants will be asked to attend the 3rd and final online meeting with the study audiologist. During this meeting, the audiologist will review the participant’s use of the app, review adherence and discuss steps for post-trial care. The participant is also free to ask any app-use questions they may have. 5) Follow-up visit (1-2 hours) (3-3.5 months from baseline visit): Participants (both intervention and control groups) will be asked to complete a second visit for a follow-up assessment. The assessments performed during this visit will be the same as the ones performed during the baseline visit. This visit is scheduled up to one week after their 3rd online meeting with the study audiologist.