Clinical trial NCT06905158: Evaluation of a Non-invasive Tinnitus Device for the Management of Tinnitus Symptoms in Military Veterans
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus
Non-invasive device
Sound therapy
Tinnitus device
White noise device
Military veterans
Lead sponsor: Combat Stress
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist-controlled trial
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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]
measure: 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]
Secondary outcomes:
measure: Satisfaction of life as measured using the Satisfaction with life Scale (SWLS)
timeFrame: [Time Frame: Change from baseline SWLS score at one-month post-randomisation and two-months post-randomisation]
measure: Sleep as measured using the Insomnia Severity Index (ISI)
timeFrame: [Time Frame: Change from baseline ISI score at one-month post-randomisation and two-months post-randomisation]
Other outcomes:
measure: Symptoms of PTSD as measured using the Posttraumatic Stress Disorder Checklist For Diagnostic and Statistical Manual of Mental Disorders-5- Short Version (PCL- 5-4)
timeFrame: [Time Frame: Predictor variable]
measure: Physical health and somatic symptoms as measured using the Patient Health Questionnaire-15
timeFrame: [Time Frame: Predictor variable]
measure: Qualitative questionnaire
timeFrame: [Time Frame: Consenting participants will be contacted at one-month post-randomisation for the immediate intervention group and two-months post-randomisation for the waitlist control group]
measure: Retention rate
timeFrame: [Time Frame: Intervention end (approximately 1 year)]
measure: • Recruitment of target sample size (n = 20)
timeFrame: [Time Frame: Study end (approximately 1 year)]
measure: Incidence of adverse events across the duration of the study
timeFrame: [Time Frame: Study end (approximately 1 year)]
Locations:
Study officials:
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