Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT06905158
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06905158
Study Brief:
Protocol Section:
NCT06905158