- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05268770
Inflammation in Tinnitus (INFLATIN)
The Role of Inflammation in the Pathogenesis of Tinnitus
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Lilian M Mennink, MD
- Phone Number: 0031503610522
- Email: l.m.mennink@umcg.nl
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- To be eligible to participate in this study, a subject must meet all of the following criteria:
- Adult, aged 18 years or older;
- Hearing threshold: average of 1000kHz, 2000kHz & 4000kHz ≤ 25 dB.
- Anxiety score HADS ≤ 7
- Depression score HADS ≤ 7
- Participant has sufficient mastery of the Dutch language to fill out the questionnaires.
- Psychosocially, mentally, and physically able to fully comply with this protocol.
Exclusion Criteria:
- Objective tinnitus.
- Presence of neurological disease (apart from tinnitus)
- Presence of inflammatory disease, or the use of anti-inflammatory medication.
- Presence or history of a malignancy
- Presence of a disease of the ear (e.g. chronic otitis media, otosclerosis, previous surgery etc).
- Presence of an coagulation disorder
- Presence of a serious psychiatric disorder.
- Pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Tinnitus patients with good hearing
|
Healthy controls with good hearing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tinnitus vs no tinnitus
Time Frame: September 2022
|
Difference in cytokine levels between participants with and without tinnitus
|
September 2022
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tinnitus severity
Time Frame: September 2022
|
Relation between cytokine levels and tinnitus severity
|
September 2022
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202200148
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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