Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07468318
Eligibility Criteria:
Inclusion Criteria:
* 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)
* 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
Exclusion Criteria:
* Audiological/ENT Exclusions:
* Objective or pulsatile tinnitus
* Active ear pathology requiring treatment:
* Acute otitis media or externa
* Chronic suppurative otitis media
* Cholesteatoma
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07468318
Study Brief:
Protocol Section:
NCT07468318