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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT01541969
Eligibility Criteria:
Inclusion Criteria:
* Pure tone average \<60 dB HL in the ear where tinnitus is perceived
* Must be able to hear all stimulation tones presented by the device
* Chronic subjective tinnitus for more than 3 months
* Dominant tinnitus frequency measured between 0.2 and 10 kHz
* At least mild tinnitus score on the Tinnitus Handicap Inventory
* Willing to wear the device for 4-6 hours daily during the trial
* Sufficient command of English language to read, understand and complete the questionnaires
* Able and willing to give informed consent
Exclusion Criteria:
* Objective tinnitus, Meniere's disease, craniomandibular induced Tinnitus
* Pulsatile tinnitus
* Intermittent tinnitus
* Severe anxiety
* Severe depression
* Catastrophic tinnitus
* Hearing-aids wearers for less than 9 months
* Hearing-aid wearers with audiological adjustments within last 3 months
* Absolute thresholds \> 70 dB on individual frequencies up to 8 kHz (unable to sufficiently hear the stimulus)
* Taking part in another trial during the last 30 days before study start
* The individually tailored training stimulus is uncomfortable or not acceptable to the participant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01541969
Study Brief:
Protocol Section:
NCT01541969