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Ear NoiseSOMATINNCT07468318

Multimodal Therapy for Somatosensory Tinnitus

A study testing Multimodal physiotherapy for TMJ and Cervical spine, Combined Exercise Program (Aerobic + Resistance + Breathing) and Tinnitus-Specific Psychological Support in people with Ear Noise and Tinnitus, Noise Induced, run by Charles University, Czech Republic at 1 site in Czechia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
Multimodal physiotherapy for TMJ and Cervical spine, Combined Exercise Program (Aerobic + Resistance + Breathing) and Tinnitus-Specific Psychological Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteCzechia
Study dates
1 Jan 2027to 31 Dec 2030
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years (inclusive)
  • Chronic subjective tinnitus present for ≥6 months
  • Tinnitus Handicap Inventory (THI) score ≥18 points (indicating at least mild tinnitus handicap)
  • Positive somatosensory modulation test: ability to reproducibly modulate tinnitus (change in loudness, pitch, or quality) through at least one of the following manoeuvres:
  • Jaw movements (mouth opening, lateral excursion, protrusion, clenching)
  • Neck movements (flexion, extension, rotation, lateral flexion)
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  • Pressure on specific head/neck muscles
  • Eye movements or shoulder elevation
  • Willing and able to attend all study sessions over 28 weeks
  • Adequate cognitive capacity to understand study procedures and complete questionnaires in the Czech language
  • Signed written informed consent

Who cannot join

  • Audiological/ENT Exclusions:
  • Objective or pulsatile tinnitus
  • Active ear pathology requiring treatment:
  • Acute otitis media or externa
  • Chronic suppurative otitis media
  • Cholesteatoma
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  • Meniere's disease with recent vertigo attacks (<3 months)
  • Suspected retrocochlear pathology:
  • Acoustic neuroma (vestibular schwannoma)
  • Cerebellopontine angle tumor
  • Neurological Exclusions:
  • Neurological disease affecting brainstem or auditory pathways:
  • Multiple sclerosis with brainstem involvement
  • Stroke affecting auditory pathways
  • Brain tumor
  • Epilepsy or active seizure disorder
  • Musculoskeletal Exclusions:
  • Contraindications to manual therapy:
  • Severe cervical spine instability
  • Rheumatoid arthritis with atlantoaxial instability
  • Down syndrome
  • Vertebrobasilar insufficiency
  • Severe osteoporosis with fracture risk
  • Recent cervical spine surgery (<6 months)
  • Recent head or neck trauma (<3 months)
  • Ongoing physiotherapy or manual therapy for temporomandibular joint or cervical spine (<3 months prior to enrollment)
  • Psychiatric Exclusions:
  • Severe psychiatric disorder:
  • Active psychosis
  • Severe depression requiring inpatient treatment
  • Acute suicidal ideation (PHQ-9 item 9 score ≥2)
  • Active substance abuse disorder
  • Other Exclusions:
  • Pregnancy (due to modifications needed in physical examination and treatment)
  • Ongoing litigation or compensation claims related to tinnitus or hearing loss
  • Current participation in another interventional clinical trial
  • Expected change of residence or long-term absence (>2 weeks) during the study period
  • Unable or unwilling to comply with study procedures and attend all sessions

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jitka Malá, PhDr. Ph.D. contact

+420608111418

jitka.mala@ftvs.cuni.cz

Czechia1 site

  • Charles University Faculty of physical education and sport

    Prague

    Jitka Malá, PhDr. PhD., +420608111418, jitka.mala@ftvs.cuni.cz

    Jitka Malá, PhDr. Ph.D.

Other trials in Czechia

About this study

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

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.

Read more

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.

Read the 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).

Being tested
Multimodal physiotherapy for TMJ and Cervical spine, Combined Exercise Program (Aerobic + Resistance + Breathing), Tinnitus-Specific Psychological Support
Keywords
exercise therapy, tinnitus, multimodal therapy, subjective noise, somatosensory tinnitus, physiotherapy
Medical subject headings
Tinnitus, Temporomandibular Joint Disorders, Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimodal physiotherapy for TMJ and Cervical spineOther

    Also called physiotherapy, manual therapy

    Manual therapy (mobilisations of TMJ and cervical spine C0-C7, myofascial techniques, intraoral TMJ techniques with gloves), neuromuscular exercise (CCFT with pressure biofeedback, scapular stabilisation, proprioceptive training), home exercise program. 16 sessions × 60 min over 8 weeks. Arms: Arm 1.

  • Combined Exercise Program (Aerobic + Resistance + Breathing)Behavioural

    Also called physical therapy, motion

    Structured 8-week combined exercise program: aerobic training (60-85% HRmax), progressive resistance training (40-80% 1RM), breathing and relaxation exercises (diaphragmatic breathing, box breathing, resonant breathing). 24 sessions × 60 min; 1× supervised/week + 2× home-based/week. Strict instructions to avoid the Valsalva manoeuvre. Arms: Arm 1.

  • Tinnitus-Specific Psychological SupportBehavioural

    Also called psychological approach

    One group psychoeducation session (90 min): vicious cycle model of tinnitus distress, cognitive restructuring, attention regulation training, relaxation technique. Weekly self-help materials (worksheets, audio recordings, mindfulness). On-demand individual psychological support (max. 3 sessions per 8 weeks). Arms: Arm 1.

Study groups in NCT07468318
Study groupRoleWhat they receive
Multimodal Interventional GroupExperimental8-week multimodal program: physiotherapy (16 sessions × 60 min, 2×/week) + structured exercise program (24 sessions × 60 min, 3×/week) + psychological support (1× group session 90 min + weekly self-help materials + on-demand support). Total: 5 sessions/week.
Receives: Other: Multimodal physiotherapy for TMJ and Cervical spine; Behavioral: Combined Exercise Program (Aerobic + Resistance + Breathing); Behavioral: Tinnitus-Specific Psychological Support
Control GroupNo interventionNo structured physiotherapy, exercise program, or tinnitus-specific psychological intervention. Participants continue usual care (stable pharmacological treatment permitted). Assessed at identical time points. Offered full multimodal intervention after study completion (ethical cross-over).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Tinnitus Handicap Inventory (THI) score

    The primary outcome is the change in tinnitus-related handicap measured by the Tinnitus Handicap Inventory (THI).

    The THI is a 25-item self-report questionnaire assessing the functional, emotional, and catastrophic impact of tinnitus on daily life.

    Total scores range from 0 to 100, where higher scores indicate greater tinnitus-related handicap.

    The primary analysis will compare the change in THI score from baseline between the multimodal intervention group and the control group.

    Measured: Baseline, 4 weeks, 8 weeks (end of intervention), 3 months, 12 months, and 24 months.

Secondary outcomes (9)

  1. Change in tinnitus loudness assessed by Visual Analogue Scale (VAS)

    Change in perceived tinnitus loudness measured by the Visual Analogue Scale (VAS).

    The VAS is a single-item self-report scale ranging from 0 to 10, where 0 indicates no tinnitus loudness and 10 indicates the worst imaginable tinnitus loudness.

    Measured: Baseline, 8 weeks, 3 months, 12 months, 24 months

  2. Change in quality of life assessed by the Short Form Health Survey (SF-36)

    Change in health-related quality of life measured by the Short Form Health Survey (SF-36). The SF-36 is a 36-item self-report questionnaire assessing 8 domains of health-related quality of life. Scores range from 0 to 100 for each domain, where higher scores indicate better quality of life.

    Measured: Baseline, 4 weeks, 8 weeks, 3 months, 12 months, 24 months

  3. Change in cervical range of motion assessed by goniometry

    Change in active cervical range of motion measured by goniometry. Cervical range of motion will be assessed in all planes: flexion, extension, lateral flexion (left/right), and rotation (left/right). The unit of measure is degrees (°). Higher values indicate greater cervical mobility.

    Measured: Baseline, 8 weeks, 3 months, 12 months, 24 months

  4. Change in well-being assessed by the World Health Organization Five Well-Being Index (WHO-5)

    Change in subjective well-being measured by the World Health Organization Five Well-Being Index (WHO-5). The WHO-5 is a 5-item self-report questionnaire. Scores range from 0 to 25, where higher scores indicate better well-being.

    Measured: Baseline, 4 weeks, 8 weeks, 3 months, 12 months, 24 months.

  5. Change in anxiety symptoms assessed by the Generalized Anxiety Disorder 7-item scale (GAD-7)

    Change in anxiety symptoms measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 is a 7-item self-report questionnaire. Scores range from 0 to 21, where higher scores indicate more severe anxiety symptoms.

    Measured: Baseline, 4 weeks, 8 weeks, 3 months, 12 months, 24 months.

  6. Change in depressive symptoms assessed by the Patient Health Questionnaire (PHQ-9)

    Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item self-report questionnaire. Scores range from 0 to 27, where higher scores indicate more severe depressive symptoms.

    Measured: Baseline, 4 weeks, 8 weeks, 3 months, 12 months, 24 months.

  7. Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Change in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 19-item self-report questionnaire assessing sleep quality over the past month. Scores range from 0 to 21, where higher scores indicate poorer sleep quality.

    Measured: Baseline, 4 weeks, 8 weeks, 3 months, 12 months, 24 months.

  8. Change in temporomandibular joint range of motion assessed by direct measurement

    Change in temporomandibular joint (TMJ) range of motion measured by direct millimeter measurement using a ruler/caliper. Assessed parameters include maximum mouth opening, lateral mandibular movements (left/right), and protrusion. The unit of measure is millimeters (mm). Higher values indicate greater TMJ mobility.

    Measured: Baseline, 8 weeks, 3 months, 12 months, 24 months.

  9. Change in cervical muscle tone assessed by algometry (pressure pain threshold)

    Change in cervical muscle tone measured by pressure algometry. Pressure pain threshold (PPT) will be assessed bilaterally at standardized trigger point locations in the cervical and craniocervical region (m. trapezius, m. sternocleidomastoideus, suboccipital muscles, m. levator scapulae). The unit of measure is kilopascals (kPa) or kilograms per square centimeter (kg/cm²). Higher values indicate lower muscle tenderness and better muscle tone.

    Measured: Baseline, 8 weeks, 3 months, 12 months, 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion30 Jun 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Parallel assignment (RCT: intervention vs. control) + Crossover assignment
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07468318
Sponsor's protocol ID
team Tinnitus
Acronym
SOMATIN
Status last verified
Mar 2026
First submitted
5 Feb 2026
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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