TinnitusNCT06905158
Evaluation of a Non-invasive Tinnitus Device for the Management of Tinnitus Symptoms in Military Veterans
A study testing White noise device in people with Tinnitus, run by Combat Stress at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- White noise device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Oct 2025to 8 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- White noise device
- Keywords
- Tinnitus, Non-invasive device, Sound therapy, Tinnitus device, White noise device, Military veterans
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White noise deviceDevice
Also called TinniSoothe, Non-invasive white noise device, Tinnitus sound 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
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention arm | Experimental | All participants will receive the non-invasive device to their registered address and will be asked to use it for a period of one month. This will involve wearing the device around ones neck or body during the day and docking it at night for 24/7 relief. Participants can alter the volume and frequency of the device to fit into their individual experience. Receives: Device: White noise device |
| Waitlist control arm | Other | The WL control group will receive the device one-month post-randomisation Receives: Device: White noise device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of tinnitus measured using the Tinnitus Functional Index (TF)
Scores range from 0-250, with higher scores indicating greater tinnitus symptoms
Measured: [Time Frame: Change from baseline TFI score at one-month post-randomisation and two-months post-randomisation]
Symptoms of mental health difficulties measured using the General Health Questionnaire-12
Scores range from 0-36, with higher scores indicating greater psychological distress
Measured: [Time Frame: Change from baseline General Health Questionnaire-12 score at one-month post-randomisation and two-months post-randomisation]
Secondary outcomes (2)
Satisfaction of life as measured using the Satisfaction with life Scale (SWLS)
Scores range from 5-35, with a higher score indicating greater life satisfaction.
Measured: [Time Frame: Change from baseline SWLS score at one-month post-randomisation and two-months post-randomisation]
Sleep as measured using the Insomnia Severity Index (ISI)
Scores range from 0-28, with a higher score indicating greater insomnia severity.
Measured: [Time Frame: Change from baseline ISI score at one-month post-randomisation and two-months post-randomisation]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start6 Oct 2025
- Primary completion8 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Waitlist-controlled trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combat Stress
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905158
- Sponsor's protocol ID
- No ID yet
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable information will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06905158
- Acronym / sponsor ID
- No ID yet
- Conditions
- Tinnitus
- Keywords
- Tinnitus, Non-invasive device, Sound therapy, Tinnitus device, White noise device, Military veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Combat StressUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention arm | Experimental | Device: White noise deviceAll participants will receive the non-invasive device to their registered address and will be asked to use it for a period of one month. This will involve wearing the device around ones neck or body during the day and docking it at night for 24/7 relief. Participants can alter the volume and frequency of the device to fit into their individual experience. |
| Waitlist control arm | Other | Device: White noise deviceThe WL control group will receive the device one-month post-randomisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White noise deviceAlso: TinniSoothe, Non-invasive white noise device, Tinnitus sound 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 | Device | Immediate intervention arm, Waitlist control arm |
Primary outcome
Symptoms of tinnitus measured using the Tinnitus Functional Index (TF)
Time frame: [Time Frame: Change from baseline TFI score at one-month post-randomisation and two-months post-randomisation]
Scores range from 0-250, with higher scores indicating greater tinnitus symptoms
Symptoms of mental health difficulties measured using the General Health Questionnaire-12
Time frame: [Time Frame: Change from baseline General Health Questionnaire-12 score at one-month post-randomisation and two-months post-randomisation]
Scores range from 0-36, with higher scores indicating greater psychological distress
2 secondary outcomes
Satisfaction of life as measured using the Satisfaction with life Scale (SWLS)
Time frame: [Time Frame: Change from baseline SWLS score at one-month post-randomisation and two-months post-randomisation]
Sleep as measured using the Insomnia Severity Index (ISI)
Time frame: [Time Frame: Change from baseline ISI score at one-month post-randomisation and two-months post-randomisation]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. No identifiable information will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White noise device in people with Tinnitus, run by Combat Stress at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of tinnitus measured using the Tinnitus Functional Index (TF) (time frame: [Time Frame: Change from baseline TFI score at one-month post-randomisation and two-months post-randomisation]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.