Status:
NOT_YET_RECRUITING
Evaluation of a Non-invasive Tinnitus Device for the Management of Tinnitus Symptoms in Military Veterans
Lead Sponsor:
Combat Stress
Conditions:
Tinnitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 live...
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, t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06905158
Start Date
October 1 2025
End Date
January 1 2027
Last Update
September 30 2025
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