Tinnitus Clinical Trial
Official title:
Examining Variables Affecting Patient Participation in Clinical Trials for Tinnitus
| NCT number | NCT05811871 |
| Other study ID # | 84411336 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2024 |
| Est. completion date | April 2026 |
Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative. The goal is to identify the obstacles and challenges that prevent participation in tinnitus clinical studies, as well as the reasons for withdrawal or discontinuation. The insights gained from this study will ultimately benefit those with tinnitus who may be invited to participate in clinical research in the years to come.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | April 2026 |
| Est. primary completion date | April 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Diagnosed with tinnitus - Willing to comply with all study related procedures and assessments - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - No documented diagnosis of tinnitus - Any other health problems that would prohibit safe participation in the study - Pregnant or planning to become pregnant while enrolled in the study |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
Farr MR, Moraleda Deleito J, Xu Y, Ray J. Developing a one-stop tinnitus service: outcomes of a joined up management strategy: a retrospective observational cohort study. J Eval Clin Pract. 2016 Feb;22(1):93-97. doi: 10.1111/jep.12442. Epub 2015 Aug 28. — View Citation
Natalini E, Fioretti A, Riedl D, Moschen R, Eibenstein A. Tinnitus and Metacognitive Beliefs-Results of a Cross-Sectional Observational Study. Brain Sci. 2020 Dec 23;11(1):3. doi: 10.3390/brainsci11010003. — View Citation
Tinnitus Retraining Therapy Trial Research Group; Scherer RW, Formby C. Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2019 Jul 1;145(7):597-608. doi: 10.1001/jamaoto.2019.0821. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of tinnitus patients who decide to enroll in a clinical study | 3 months | ||
| Primary | Rate of tinnitus patients who remain in a clinical study to completion | 12 months |
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|---|---|---|---|
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