TIDE Project: Biomarker Discovery for Chronic Tinnitus Diagnosis
United States, Belgium, Germany560 participantsStarted 2024-08-01
Plain-language summary
Research in clinical neuroscience is founded on the conviction that a better understanding of tinnitus related changes of brain function will improve our ability to diagnose and treat tinnitus. Although considerable advances have been made in understanding the mechanisms of tinnitus, the clinical management of tinnitus remains largely based on a 'trial and error' approach. The identification and validation of a biomarker for tinnitus is thought to be the crucial step in the development of a personalized approach to the diagnosis and treatment of tinnitus. The overarching goal of this study is to incorporate advanced technologies to provide an objective, data-driven, personalized approach to the diagnosis of chronic tinnitus. This should lead to a clinically applicable tool that can be widely and easily used.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
(1) for tinnitus cases: a diagnosis of chronic and constant tinnitus (for at least 6 months based on history)
* (2) for controls: never experienced tinnitus
* (3) age 18 -70;
* (4) ability to understand and consent to the research;
* (5) ability to participate (hearing ability);
* (6) MoCa Test ≥ 26;
* (7) hyperacusis questionnaire score \< 27;
Exclusion Criteria:
* (1) objective tinnitus; heartbeat-synchronous tinnitus as primary complaint;
* (2) otosclerosis; acoustic neuroma or other relevant ear disorders with fluctuating hearing;
* (3) acute ear nose and throat infections (acute otitis media, otitis externa, acute sinusitis);
* (4) Meniere's disease or similar syndromes;
* (5) vestibular migraine;
* (6) serious internal, neurological or psychiatric conditions;
* (7) epilepsy or other CNS disorders (brain tumor, encephalitis);
* (8) clinically relevant drug, medication or alcohol abuse up to 12 weeks before study start;
* (9) change in anti-depressants/drugs ≤ 2 weeks
* (10) missing written informed consent
* (11) severe hearing loss - inability to communicate properly in the course of the study;
* (12) one deaf ear;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.