Clinical Trial

Multimodal Therapy for Somatosensory Tinnitus

Study acronym: SOMATIN
Not Yet Recruiting
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Summary
Tinnitus (ringing or buzzing in the ears) affects approximately 10-15% of the adult population and significantly reduces quality of life in many patients. In a substantial proportion of cases, tinnitus is associated with dysfunction of the temporomandibular joint (TMJ) and cervical spine - this subtype is called somatosensory tinnitus. This randomised controlled trial investigates the effectiveness of a multimodal intervention combining: (1) physiotherapy targeting TMJ and cervical spine dysfunction, (2) a structured combined exercise program (aerobic + resistance + breathing), and (3) psychological support (cognitive-behavioural psychoeducation) in patients with chronic somatosensory tinnitus. The study also examines the acute effects of different types and intensities of physical exercise on tinnitus perception, and performs psychometric validation of Czech-language tinnitus assessment questionnaires. Participants (N=160, aged 18-70 years) will be randomly assigned to either the multimodal intervention group (8 weeks, 5 sessions/week) or a control group. Follow-up assessments will be conducted at 3, 12, and 24 months. The primary outcome is the change in the Tinnitus Handicap Inventory (THI) score.
Trial Details
NCT Number NCT07468318
Lead Sponsor Charles University, Czech Republic
Collaborators: Neticho n.s. (Patient Organization for Tinnitus), Czech Republic, University Hospital Regensburg, AKESO Clinic, Prague, Czech Republic
Conditions Ear Noise, Tinnitus, Noise Induced, Tinnitus, Subjective, Headache Other, Temporomandibular Dysfunction, Cervical Migraine Syndrome, Chronic Tinnitus
Enrollment 160 participants
Start Date 2027-01-01
Primary Completion 2030-06-30 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-12