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:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT04623957
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients (aged \> 18 years)
* Subjective tinnitus in one or both ears with intermittent or continuous symptoms with a duration of \> 6 months
* Tinnitus of Grade II, III or IV according to Mini-Tinnitus-Questionnaire (Mini-TF12):
* Grade II (score of 8-12): moderately distressed
* Grade III (score of 13-18): severely distressed
* Grade III (score of 19-24): most severely distressed
* If a drug therapy with psychoactive substances (e.g. antidepressants, anticonvulsants) exists at the beginning of the therapeutic intervention, it must have been stable for at least 30 days. The therapy should remain constant during the duration of the study, but a necessary change is not an exclusion criterion. Any change in medication is documented in the CRF.
* Provides written informed consent
Exclusion Criteria:
* Vestibular schwannoma (acoustic neuroma)
* Objective tinnitus
* Any other tinnitus-related treatment
* Ménière's Disease
* Acute infections of the hearing system (acute otitis media, otitis externa, acute sinusitis)
* Acute infections (acute otitis media, otitis externa, acute sinusitis)
* Hearing aids or Cochlear Implants (CI)
* Any current treatment with anticonvulsants, cortisone, tricyclic antidepressants
* Other lesions (glomus tumors, meningiomas, adenomas, vascular lesions or neuro-vascular conflicts) detected by clinical assessment
* Serious, concomitant disorder, including major depression, anxiety
* Any condition that, in the judgment of the investigator, might prevent safe participation in the study or interfere with study objectives
* Inability to comply with the protocol requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04623957
Study Brief:
Protocol Section:
NCT04623957