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Inflammation in Tinnitus (INFLATIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05268770
Recruitment Status : Not yet recruiting
First Posted : March 7, 2022
Last Update Posted : March 7, 2022
Sponsor:
Information provided by (Responsible Party):
University Medical Center Groningen

Brief 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.


Condition or disease
Tinnitus, Subjective Tinnitus Inflammation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Group/Cohort
Tinnitus patients with good hearing
Healthy controls with good hearing



Primary Outcome Measures :
  1. Tinnitus vs no tinnitus [ Time Frame: September 2022 ]
    Difference in cytokine levels between participants with and without tinnitus


Secondary Outcome Measures :
  1. Tinnitus severity [ Time Frame: September 2022 ]
    Relation between cytokine levels and tinnitus severity


Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult patients seeking medical attention at the tinnitus consultation of the otorhinolaryngology department are eligible. Each week, six patients attend the tinnitus consultation. From these patients, we estimate that about a third of the patients meets the inclusion criteria. Additionally, tinnitus patients can be recruited from the tinnitus database of the otorhinolaryngology department. As controls, healthy participants without tinnitus will be included. We expect no difficulties recruiting the planned number of patients from both populations.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Lilian M Mennink, MD 0031503610522 l.m.mennink@umcg.nl

Sponsors and Collaborators
University Medical Center Groningen
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Responsible Party: University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT05268770    
Other Study ID Numbers: 202200148
First Posted: March 7, 2022    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tinnitus
Inflammation
Pathologic Processes
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases