NCT06905158

Evaluation of a Non-invasive Tinnitus Device for the Management of Tinnitus Symptoms in Military Veterans

Evaluating the Effectiveness of a Non-invasive Tinnitus Device in Reducing Symptoms of Tinnitus and Mental Health Difficulties in Military Veterans: A Pilot Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Combat Stress · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The prevalence of tinnitus in military veterans is notably higher than the non-veteran population and can significantly disrupt the lives of veterans. Given the profound impact of tinnitus on the lives of veterans, along with the considerable economic burden and barriers to treatment, it is crucial to explore the feasibility of new approaches. Wearable sound technologies offer a non-invasive and easily accessible approach. As such, this waitlist-controlled trial aims to assess the efficacy of this new non-invasive white noise wearable device in reducing tinnitus symptoms between baseline and the one-month post-randomisation among veterans who have experienced tinnitus for at least three months.

Detailed description

The presence of tinnitus has been significantly associated with depression, anxiety, sleep difficulties and job performance in addition to poorer general physical health.. However, to our knowledge, there is currently no intervention for tinnitus that is supported as effective for most people. As such, there is a need to explore alternative approaches. Sound therapy offers an easily accessible, non-invasive, low-cost option. As such, this study aims to explore the effectiveness of a non-invasive white noise device in reducing symptoms of tinnitus and mental health difficulties in military veterans. A total of 20 military veterans who have self-reported experiencing tinnitus for at least three months will be recruited. : In this waitlist-controlled trial, the tinnitus device will be compared to the waitlist-controlled group who will receive the device one-month post-randomisation. The trial will be conducted in a veteran population (n = 20) that was recruited from a prior study that had aimed to explore the impact of tinnitus on wellbeing within a veteran population. Once the participants receive the tinnitus device, they will be asked to use the device for a period of one month. The primary outcome is the change in self-reported tinnitus symptoms and mental health difficulties between baseline (day 0) and the one-month post-randomisation (day 28). The outcome variables of interest will be assessed at all timepoints (baseline, one-month post-randomisation, and two-months post-randomisation) and the predictor variables will only be assessed at baseline to reduce participant burden. It is hypothesised that the non-invasive device will result in significant reductions in symptoms of tinnitus (as indicated using the TFI) and mental health difficulties (as measured using the gHQ-12) from baseline to one-month post-intervention in comparison to a waitlist control.

Conditions

• Tinnitus

Interventions

Type	Name	Description
DEVICE	White noise device	* Product name: TinniSoothe white noise-non-invasive tinnitus device * Usage: Worn around the neck during the daytime and docked to a stand at night * Duration: At least one-month of use

Timeline

• Start date: 2025-10-06
• Primary completion: 2026-01-08
• Completion: 2026-01-08
• First posted: 2025-04-01
• Last updated: 2026-03-13

Locations

1 site across 1 country: United Kingdom