Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 2:48 PM
Study NCT ID:
NCT07468318
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Therapy for Somatosensory Tinnitus
Sponsor:
Charles University, Czech Republic
Organization:
Study Overview
Official Title:
Multimodal Therapeutic Approach to Tinnitus Treatment With Focus on Somatosensory Components: A Randomised Controlled Trial Integrating Physiotherapy, Structured Exercise Program, and Psychological Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOMATIN
Brief 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.
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.
Detailed Description:
Background: Somatosensory tinnitus represents a clinically significant subgroup in which tinnitus is modulated by somatic manoeuvres (jaw movements, cervical rotation, trigger point palpation). The neuroanatomical basis involves convergence of somatosensory afferents from the TMJ and upper cervical spine (C1-C3) in the medullary nucleus spinalis nervi trigemini, with excitatory projections to the dorsal cochlear nucleus (DCN), leading to disinhibition of spontaneous neural activity perceived as tinnitus (Da Silva et al., 2023). Despite this evidence, multimodal treatment protocols specifically targeting somatosensory tinnitus remain largely absent from clinical practice in the Czech Republic.
Study Design: Single-centre randomized controlled trial with longitudinal follow-up and a crossover substudy on acute exercise effects. Stratified randomization by age group (18-35 / 36-50 / 51-70 years) and sex. Rotating block system: 4 blocks of \~27 participants; 8 weeks active intervention + 8 weeks pause per block.
Intervention: 8-week multimodal program comprising: (A) Physiotherapy - 16 sessions × 60 min: manual therapy of TMJ and cervical spine (myofascial techniques including intraoral TMJ techniques), neuromuscular exercise, proprioceptive training, home exercise program; (B) Exercise Program - 24 sessions × 60 min: combined aerobic (60-85% HRmax), resistance (40-80% 1RM), and breathing/relaxation training; 1× supervised/week + 2× home-based/week; (C) Psychological Support - 1× group psychoeducation session (90 min): cognitive-behavioral model of tinnitus distress, attention regulation, relaxation; weekly self-help materials; on-demand psychological support (max. 3× per 8 weeks).
Crossover Substudy: Repeated measures crossover design examining acute effects of 5 standardized conditions (low/high intensity aerobic exercise; low/high intensity resistance exercise; control rest) on tinnitus perception (VAS loudness and distress), with ≥48-72h washout between conditions.
Questionnaire Validation: Psychometric validation of Czech versions of THI, TFI, TCS, MTQ, CRF, TSCHQ, MDI, and WB questionnaires according to COSMIN guidelines, including reliability, validity, responsiveness, and MID determination.
Outcomes: Primary: THI change from baseline to 3, 12, and 24 months. Secondary: TFI, VAS/NRS, CGI, GAD-7, PHQ-9, PSQI, SF-36, WHO-5, cervical ROM, TMJ function (JFLS-20), NDI, CPET parameters (VO₂peak), body composition (BIA), muscle strength, autonomic regulation (BP, HR, PWV), and EEG spectral analysis (exploratory).
Study Design: Single-centre randomized controlled trial with longitudinal follow-up and a crossover substudy on acute exercise effects. Stratified randomization by age group (18-35 / 36-50 / 51-70 years) and sex. Rotating block system: 4 blocks of \~27 participants; 8 weeks active intervention + 8 weeks pause per block.
Intervention: 8-week multimodal program comprising: (A) Physiotherapy - 16 sessions × 60 min: manual therapy of TMJ and cervical spine (myofascial techniques including intraoral TMJ techniques), neuromuscular exercise, proprioceptive training, home exercise program; (B) Exercise Program - 24 sessions × 60 min: combined aerobic (60-85% HRmax), resistance (40-80% 1RM), and breathing/relaxation training; 1× supervised/week + 2× home-based/week; (C) Psychological Support - 1× group psychoeducation session (90 min): cognitive-behavioral model of tinnitus distress, attention regulation, relaxation; weekly self-help materials; on-demand psychological support (max. 3× per 8 weeks).
Crossover Substudy: Repeated measures crossover design examining acute effects of 5 standardized conditions (low/high intensity aerobic exercise; low/high intensity resistance exercise; control rest) on tinnitus perception (VAS loudness and distress), with ≥48-72h washout between conditions.
Questionnaire Validation: Psychometric validation of Czech versions of THI, TFI, TCS, MTQ, CRF, TSCHQ, MDI, and WB questionnaires according to COSMIN guidelines, including reliability, validity, responsiveness, and MID determination.
Outcomes: Primary: THI change from baseline to 3, 12, and 24 months. Secondary: TFI, VAS/NRS, CGI, GAD-7, PHQ-9, PSQI, SF-36, WHO-5, cervical ROM, TMJ function (JFLS-20), NDI, CPET parameters (VO₂peak), body composition (BIA), muscle strength, autonomic regulation (BP, HR, PWV), and EEG spectral analysis (exploratory).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: