Biomarker discovery for chronic tinnitus diagnosis
Identification and Validation of a Biomarker for Tinnitus: an Objective Data-driven Personalized Approach to Diagnosis of Chronic Tinnitus - The Tinnitus Detection (TIDE) Project
This study is trying to find a new way to diagnose chronic tinnitus by looking for specific markers in the body that can help tell how severe the condition is, using both people with tinnitus and healthy individuals for comparison.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 560 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Regensburg Academic / other |
| Locations | 7 sites (Champaign, Illinois and 6 other locations) |
| Trial ID | NCT06520865 on ClinicalTrials.gov |
What this trial studies
This research aims to enhance the diagnosis and treatment of chronic tinnitus by identifying and validating a biomarker associated with the condition. The study employs advanced acoustic paradigms, including Gap prepulse inhibition of the acoustic startle (GPIAS), to objectively assess tinnitus and its intensity. By combining these innovative approaches, the goal is to develop a clinically applicable tool that offers a personalized and data-driven method for diagnosing tinnitus, moving away from the traditional trial-and-error strategies. The study involves participants with chronic tinnitus and healthy controls to compare their auditory processing responses.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 with a diagnosis of chronic tinnitus lasting at least six months.
Not a fit: Patients with objective tinnitus or other specific ear disorders, as well as those with serious neurological or psychiatric conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and personalized diagnostic tools for chronic tinnitus, improving treatment outcomes for patients.
How similar studies have performed: While there have been advances in understanding tinnitus, this approach to biomarker discovery is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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; * (8) Hospital Anxiety and Depression Scale (HADS) \<14; 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;
Where this trial is running
Champaign, Illinois and 6 other locations
- University of Illinois — Champaign, Illinois, United States (Recruiting)
- University of Texas — Austin, Texas, United States (Recruiting)
- Brai3n - Research center for Advanced, International, Innovative and Interdisciplinary Neuromodulation — Gent, Belgium (Recruiting)
- University of Tuebingen — Tuebingen, Baden-Wuerttemberg, Germany (Recruiting)
- Center of Neuromodulation - Psychiatry und Psychotherapie der Universität Regensburg am Bezirksklinikum — Regensburg, Bavaria, Germany (Recruiting)
- Trinity College Dublin — Dublin, Ireland (Recruiting)
- OST - Eastern Switzerland University of Applied Sciences — St. Gallen, Switzerland (Recruiting)
Study contacts
- Principal investigator: Sven Vanneste, Prof. — Trinnitus College Dublin
- Study coordinator: Berthold Langguth, Prof.
- Email: berthold.langguth@medbo.de
- Phone: +49 941 941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.