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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT04004260
Eligibility Criteria:
Inclusion Criteria:
1. aged 18 years and older living in the State of Texas, USA;
2. the ability to read and type in English or Spanish;
3. no barriers to using a computer (e.g. no significant fine motor control or visual problems);
4. Internet and e-mail access and the ability to use it;
5. commitment to completing the program;
6. completion of the online screening and outcome questionnaires;
7. agreeing to participate in either group and be randomized to one of these groups;
8. understanding and working towards the end goal of reducing the impact and distress of tinnitus, although the strength of the tinnitus may remain the same;
9. be available for 12 months after starting the study to complete a 1-year follow-up questionnaire;
10. suffering with experiencing tinnitus for a minimum period of 3 months; and
11. tinnitus outcome measure scores indicating the need for tinnitus care \[25 or above on the Tinnitus Functional Index (TFI)\].
Exclusion Criteria:
1. reporting any major medical or psychiatric conditions;
2. reporting pulsatile, objective or unilateral tinnitus, which has not been investigated medically;
3. tinnitus as a consequence of a medical disorder, still under investigation; and
4. undergoing any other tinnitus therapy while participating in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04004260
Study Brief:
Protocol Section:
NCT04004260