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Multimodal Therapy for Somatosensory Tinnitus

Study acronym: SOMATIN
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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
(from sponsor)
Ear Noise, Tinnitus, Noise Induced, Tinnitus, Subjective, Headache Other, Temporomandibular Dysfunction, Cervical Migraine Syndrome, Chronic Tinnitus
Related terms Migraine Disorders, Temporomandibular Joint Disorders, Tinnitus
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov