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

NCT06905158 | Completed

• 1 other identifier: No ID yet
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

Tinnitus; Non-invasive device; Sound therapy; Tinnitus device; White noise device; Military veterans

Outcome Measures

Primary Outcomes (2)

• Symptoms of tinnitus measured using the Tinnitus Functional Index (TF)

  Scores range from 0-250, with higher scores indicating greater tinnitus symptoms

  [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

  [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)

  [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: Change from baseline ISI score at one-month post-randomisation and two-months post-randomisation]

Other Outcomes (6)

• 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)

  [Time Frame: Predictor variable]

• Physical health and somatic symptoms as measured using the Patient Health Questionnaire-15

  [Time Frame: Predictor variable]

• Qualitative questionnaire

  [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]

Study Arms (2)

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.

Device: White noise device

Waitlist control arm

OTHER

The WL control group will receive the device one-month post-randomisation

Device: White noise device

Interventions

White noise device 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

Also known as: TinniSoothe, Non-invasive white noise device, Tinnitus sound device

Immediate intervention arm; Waitlist control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Combat Stress: lead

Study Sites (1)

Combat Stress

Leatherhead, KT22 0BX, United Kingdom

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Waitlist-controlled trial

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: October 6, 2025
• Primary Completion: January 8, 2026
• Study Completion: January 8, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)