Inflammation in Tinnitus (INFLATIN)
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|ClinicalTrials.gov Identifier: NCT05268770|
Recruitment Status : Not yet recruiting
First Posted : March 7, 2022
Last Update Posted : March 7, 2022
Rationale: Tinnitus is the perception of sound without an external source. In the past decade, inflammation has been implicated in the pathophysiology of tinnitus. In animal models of tinnitus, the expression of proinflammatory cytokines Tumor Necrosis Factor-α (TNF-α) and interleukine-1β (IL-1β) was increased throughout the whole auditory tract. Only two studies evaluated cytokine concentrations in tinnitus patients. In these studies an increase of IL-6 and decrease of IL-10 have been objectified. However, studies did not include tinnitus patients based on the degree of hearing loss, despite that inflammation has also been implicated in hearing loss. On the other hand, studies about inflammation in hearing loss did not (always) exclude tinnitus. Thus, it remains unclear whether the upregulated cytokine concentrations the studies are specific for tinnitus, and whether potential effects remained unsignificant because the presence of hearing loss is a confounder. Therefore, the aim of this study is to evaluate the presence of inflammation in tinnitus patients with normal hearing.
Objective: The main objective is to evaluate the presence of inflammation in blood samples of human subjects with tinnitus and normal hearing, compared to healthy controls. The secondary objective is to evaluate the relation between tinnitus severity and inflammatory marker concentrations.
Study design: This is a cross-sectional study.
Study population: Patients who have been referred to the tinnitus consultation at the outpatient clinic will be asked to participate in this study. For the control group, healthy volunteers will be recruited.
Main study parameters/endpoints: The main study parameter is the disparity in blood cytokine levels between participants with and without tinnitus. Secondary study parameters are the relation between tinnitus severity and blood cytokine concentration, and the difference in complete blood count measures in participants with and without tinnitus.
|Condition or disease|
|Tinnitus, Subjective Tinnitus Inflammation|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||The Role of Inflammation in the Pathogenesis of Tinnitus|
|Estimated Study Start Date :||March 2022|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
|Tinnitus patients with good hearing|
|Healthy controls with good hearing|
- Tinnitus vs no tinnitus [ Time Frame: September 2022 ]Difference in cytokine levels between participants with and without tinnitus
- Tinnitus severity [ Time Frame: September 2022 ]Relation between cytokine levels and tinnitus severity
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05268770
|Contact: Lilian M Mennink, MDemail@example.com|