Evaluating a tinnitus device for reducing tinnitus symptoms and mental health difficulties in veterans: waitlist-controlled trial protocol

The prevalence of tinnitus in veterans is notably higher than in the general population and can significantly disrupt daily life. Given the impact of tinnitus, along with the lack of effective interventions, exploring new approaches is warranted. Wearable sound technologies offer a non-invasive and easily accessible approach. However, limited research has explored the effectiveness of sound therapy in UK veterans. A prior study supported the feasibility and acceptability of a non-invasive wearable device (i.e., TinniSoothe) in a sample of veterans. However, a waitlist-controlled trial is needed to investigate the effectiveness of the device. This waitlist-controlled trial aims to explore the effectiveness of a wearable device in reducing tinnitus symptoms in a sample of UK veterans. Veterans will be randomly allocated to one of two conditions: (1) the immediate intervention condition, which receives the device post-randomisation, or (2) the waitlist control group, which receives the device one-month post-randomisation. The trial will be conducted in veterans (n = 20) who have experienced tinnitus. Participants will be asked to use the device for one month. The immediate intervention group will be compared to the waitlist control group. The primary outcome is change in tinnitus severity (Tinnitus Functional Index, TFI) and mental health (General Health Questionnaire-12, GHQ-12) from baseline to one-month post-randomisation. Primary and secondary outcomes will be assessed at all timepoints (baseline, one-month post-randomisation, and two-month post-randomisation), while predictor variables will only be assessed at baseline to reduce participant burden. Recruitment will begin in October 2025. The study is expected to take 12 months, with results published in 2027. This study explores whether a wearable device is efficacious in reducing self-reported symptoms of tinnitus in comparison to a waitlist control group. This innovative approach, if successful, could offer a practical option for reducing tinnitus distress. The trial is registered on clinicaltrials.gov, identifier: NCT06905158.