Objective data-driven personalised approach to diagnosis of chronic tinnitus: the Tinnitus Detection (TIDE) project - protocol for the identification and validation of a biomarker for tinnitus

BMJ Open. 2026 May 19;16(5):e112788. doi: 10.1136/bmjopen-2025-112788.

ABSTRACT

BACKGROUND: Tinnitus is the perception of sound without an external source, often considered a phantom percept similar to phantom limb sensations, resulting from maladaptive plasticity in the brain. The condition lacks an established biomarker for diagnosis but recent studies have linked it to neural changes. The Tinnitus Detection consortium aims to identify and validate potential biomarkers for tinnitus presence and intensity.

METHODS/DESIGN: This multicentre prospective case-control study will recruit 560 adults (280 chronic tinnitus; 280 controls). Participants will complete standardised audiological and questionnaire assessments and then undergo 64-channel electroencephalography (and magnetoencephalography at one site) to record event-related potentials during (1) a cortical gap prepulse inhibition of the acoustic startle (GPIAS) paradigm assessing gap-related inhibition of the N1 response and (2) an omission auditory oddball paradigm quantifying mismatch negativity and P300 as candidate biomarkers of tinnitus presence and loudness.

DISCUSSION: The identification of a biomarker for tinnitus is crucial for developing personalised diagnosis and treatment: There is a need for updated guidelines and more effective tinnitus treatments, as existing interventions often rely on subjective measures. The success of biomarkers like GPIAS and oddball paradigms could significantly improve the reliability of tinnitus diagnosis and treatment, marking a transformative step in the field.

TRIAL REGISTRATION NUMBER: NCT06520865.

PMID:42156141 | DOI:10.1136/bmjopen-2025-112788