Evaluation of a Non-invasive Tinnitus Device for the Management of Tinnitus Symptoms in Military … (NCT06905158) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of a Non-invasive Tinnitus Device for the Management of Tinnitus Symptoms in Military Veterans
United Kingdom20 participantsStarted 2025-10-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Fluent in speaking and reading English.
* United Kingdom Armed Forces veteran
* Persistent tinnitus for at least three months (participants with tinnitus had to confirm experience of constant ringing or buzzing \[bilateral or unilateral\] lasting longer than three months).
* Able to receive the TinniSoothe device to their registered address
* Able to follow study instructions
* Sign the written consent form prior to any study-related procedures being performed
Exclusion Criteria:
* Below 18 years of age
* Significant severe hearing loss without hearing aids
* Individuals who have already habituated to tinnitus
* Veterans receiving concurrent treatment for tinnitus (e.g., other wearable devices or ongoing audiological therapies)
* Active self-harm or suicidal ideation
* Severe psychotic disorder, dissociative identity disorder or other severe mental health difficulty
* Current alcohol or drug-use disorder or dependency requiring further support or treatment that would significantly impact treatment engagement, as assessed clinician
* Unwilling and/or unable to provide informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Symptoms of tinnitus measured using the Tinnitus Functional Index (TF)
Timeframe: [Time Frame: Change from baseline TFI score at one-month post-randomisation and two-months post-randomisation]
2
Symptoms of mental health difficulties measured using the General Health Questionnaire-12
Timeframe: [Time Frame: Change from baseline General Health Questionnaire-12 score at one-month post-randomisation and two-months post-randomisation]