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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT01176734
Eligibility Criteria:
Inclusion Criteria:
* Chronic tinnitus defined as a tinnitus over more than six months
* ≥31 points in the tinnitus questionnaire according to Goebel and Hiller
* Written informed consent
* Both gender, aged from 18 -75 years
* If the subject takes psychoactive medication (e.g antidepressants, anticonvulsives) therapy must be stable for at least 10 days. If a treatment with neuroleptics is necessary, only olanzapine and quetiapine should be used. The therapy should be constantly though a necessary change in medication is no reason for exclusion of the subject.
Exclusion Criteria:
* Objective tinnitus
* Participating in other tinnitus treatments within 3 months before study start
* Missing informed consent
* Pregnancy
* Bronchial asthma in medical history
* Clinically relevant internistic, neurological or psychiatric diseases
* Abuse of drugs or alcohol until 12 weeks before enrollment in the study
* Indications of structural impairment of the basal ganglia or the brain stem
* Active implants (e.g. cochlea implants, VNS, pacemaker)
* Constant all-day use of hearing instruments or noisers on the left the part-time use in special situations (e.g. watching TV is no exclusion criteria
* All dermatologic and infectious diseases which affect the area around the pinna and the ear canal
* Severe malformation of the pinna
* Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01176734
Study Brief:
Protocol Section:
NCT01176734