Tinnitus, SubjectiveINFLATINNCT05268770
Inflammation in Tinnitus
An observational study of Tinnitus, Subjective and Tinnitus, run by University Medical Center Groningen.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus, Subjective, Tinnitus, Inflammation
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Aug 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
- Conditions
- Tinnitus, Subjective, Tinnitus, Inflammation
- Medical subject headings
- Tinnitus, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tinnitus patients with good hearing | Not described | |
| Healthy controls with good hearing | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus vs no tinnitus
Difference in cytokine levels between participants with and without tinnitus
Measured: September 2022
Secondary outcomes (1)
Tinnitus severity
Relation between cytokine levels and tinnitus severity
Measured: September 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268770
- Sponsor's protocol ID
- 202200148
- Acronym
- INFLATIN
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Inflammation in the Pathogenesis of Tinnitus
- ClinicalTrials.gov ID
- NCT05268770
- Acronym / sponsor ID
- INFLATIN / 202200148
- Conditions
- Tinnitus, Subjective, Tinnitus, Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tinnitus patients with good hearing | – | – |
| Healthy controls with good hearing | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tinnitus vs no tinnitus
Time frame: September 2022
Difference in cytokine levels between participants with and without tinnitus
1 secondary outcome
Tinnitus severity
Time frame: September 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, Subjective and Tinnitus, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lilian M Mennink, MD (0031503610522, l.m.mennink@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus vs no tinnitus (time frame: September 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.