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:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT06401993
Eligibility Criteria:
Inclusion Criteria:
* Inclusion criteria for patients with chronic tinnitus
1. Chronic tinnitus patients, that is, the course of disease ≥6 months;
2. No contraindications of fNIRS scanning;
3. The age of 20 years ≤55 years old, gender is not limited, right-handed;
4. The external ear canal is unobstructed and the eardrum is intact
5. The average hearing threshold of both ears is \<35dB;
6. Normal expression and understanding ability. Inclusion criteria for healthy subjects
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1. No tinnitus, no hearing disorders and other ear diseases;
2. Good health condition, no history of mental disease and nervous system disease;
3. No contraindications of fNIRS scanning;
4. The age of 20 years ≤55 years old, gender is not limited, right-handed;
5. The external ear canal is unobstructed, and the tympanic membrane is complete;
6. Normal expression and understanding ability.
Exclusion Criteria:
* 1.A history of drug dependence or alcohol addiction; 2.Serious central system diseases or other systemic diseases such as cardiovascular and cerebrovascular diseases; 3. Patients with organic diseases such as craniocerebral trauma; 4. Sudden deafness, Meniere's disease, otosclerosis, acoustic neuroma and other inner ear or auditory nerve diseases; 5.External otitis, acute/chronic otitis media and other external ear middle-ear related diseases; 6. Patients with auditory hypersensitivity; 7. Pregnancy, preparation for pregnancy, breastfeeding population; 8. There are metal implants in the body, fNIRS detection contraindicated.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT06401993
Study Brief:
Protocol Section:
NCT06401993