Inflammation in Tinnitus

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05268770
Study type	Observational [Patient Registry]
Source	University Medical Center Groningen
Contact	Lilian M Mennink, MD
Phone	0031503610522
Email	l.m.mennink@umcg.nl
Status	Not yet recruiting
Phase
Start date	March 2022
Completion date	August 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Inflammation in Tinnitus — INFLATIN

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms