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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT06355102
Eligibility Criteria:
Inclusion Criteria:
1. Group of SSNHL with Tinnitus:
1. Age between 18 and 65 years old;
2. Meets the diagnostic criteria for SSNHL; untreated within 5 days after onset;
3. Presence of tinnitus;
4. Able to complete questionnaires independently and cooperate with fMRI and follow-up assessments.
2. Group of SSNHL without Tinnitus:
1. Age between 18 and 65 years old;
2. Meets the diagnostic criteria for SSNHL; untreated within 5 days after onset;
3. Absence of tinnitus;
4. Able to complete questionnaires independently and cooperate with fMRI and follow-up assessments.
3. Healthy Control:
1. Age between 18 and 65 years old;
2. Normal hearing screening results;
3. Able to complete questionnaires independently and cooperate with fMRI and follow-up assessments.
Exclusion Criteria:
1. Previous diagnosis of otic organic diseases such as otitis media, cholesteatoma of the middle ear, Ménière's disease, acoustic neuroma, hereditary deafness, inner ear malformations, etc.; history of ear surgery; long-term exposure to noise; use of ototoxic drugs;
2. Presence of brain organic diseases such as cerebral infarction, brain tumor, or contraindications for functional magnetic resonance imaging (fMRI) during nuclear magnetic resonance (NMR) examination;
3. History of mental illness, including anxiety, depression, insomnia, etc.;
4. Individuals unable to cooperate due to severe mental factors.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06355102
Study Brief:
Protocol Section:
NCT06355102