Tinnitus in Patients With and Without Sensorineural Hearing Loss

NCT ID: NCT04162405

Last Updated: 2019-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-07-01

Brief Summary

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The aim of this study is to evaluate hearing characteristics in patients with and without tinnitus using DPOAE and specific tinnitus severity index (TSI) and tinnitus handicap inventory (THI) questionnaires in both groups.

Purpose of the research:

Demonstrate that the characteristics of tinnitus depend on the presence and magnitude of hearing loss.

Research participants:

150 patients coming for further audiological treatment due to tinnitus. Data will be collected from an electronic database that is filled in during diagnostic processing. During the diagnostic processing, TSI and THI questionnaires will be filled in, a tone audiogram (TA) and DPOAE will be performed.

Detailed Description

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Tinnitus affects 17% of the total population and as many as 33% of the elderly and is the primary symptom in 60% of patients referred for audiological treatment. Tinnitus is the perception of sound without external stimuli. Its pathophysiological basis is unknown and therefore its treatment is difficult and understanding of other disorders that occur in the auditory system is impeded. The auditory system has a complex structure that consists of the organs of Corti, the afferent and efferent conduction pathways, the cortical auditory center and the connections that allow their integration. The pathology that develops in any of these parts leads to a heightened perception of sound by unknown mechanisms. Patients can describe tinnitus in a variety of ways, such as sea noise, rapid flow, ringing, howling and whistling. The measurement of otoacoustic emissions by distortion products (DPOAE) is the main method that allows the evaluation of the mechanical activity of the cochlea in patients with tinnitus. In these patients, hyperacusis plays an important role and it can often be a precursor to tinnitus. The aim of this study is to evaluate hearing characteristics in patients with and without tinnitus using DPOAE and specific tinnitus severity index (TSI) and tinnitus handicap inventory (THI) questionnaires in both groups.

Research goal:

Identify differences in tinnitus characteristics in patients with and without significant hearing impairment.

Purpose of the research:

Demonstrate that the characteristics of tinnitus depend on the presence and magnitude of the visual hearing impairment.

Research participants:

150 patients coming for further audiological treatment due to tinnitus. The data will be collected from an electronic database that is filled in during diagnostic processing. During the diagnostic processing, TSI and THI questionnaires will be filled in, a tone audiogram (TA) and DPOAE will be made.

Research plan:

A prospective cohort nonrandomized study of non-masked parallel paired groups. When receiving patients at the Hearing and Balance Center, the inclusion criteria for admission to the study are adulthood (\> 18 years), tinnitus as the primary reason for referring to diagnostic treatment, and consent to complete two on-site tinnitus questionnaires. Exclusion criteria are conductive hearing impairment and incomplete questionnaires. It is planned to evaluate the differences in tinnitus character between groups of patients with and without significant hearing impairment with respect to the objective parameters of the audiogram and DPAOE.

Primary Outcome:

Identification of key differences in subjective and objective characteristics of tinnitus in patients with and without noticeable hearing impairment.

There is no risk involved in this research.

Conditions

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Tinnitus, Subjective Hearing Loss Otorhinolaryngologic Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with tinnitus and hearing loss

Patients with tinnitus and average speech-frequency tonal audiogram threshold \>30 dB

Tinnitus Handicap Inventory Test

Intervention Type BEHAVIORAL

A prospective cohort nonrandomized study of non-masked parallel paired groups. The data will be collected from an electronic database that is filled in during diagnostic processing. During the diagnostic processing, TSI and THI questionnaires will be filled in, a tone audiogram (TA) and DPOAE will be performed.

Patients with tinnitus without hearing loss

Patients with tinnitus and average speech-frequency tonal audiogram threshold \<30 dB

Tinnitus Handicap Inventory Test

Intervention Type BEHAVIORAL

A prospective cohort nonrandomized study of non-masked parallel paired groups. The data will be collected from an electronic database that is filled in during diagnostic processing. During the diagnostic processing, TSI and THI questionnaires will be filled in, a tone audiogram (TA) and DPOAE will be performed.

Interventions

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Tinnitus Handicap Inventory Test

A prospective cohort nonrandomized study of non-masked parallel paired groups. The data will be collected from an electronic database that is filled in during diagnostic processing. During the diagnostic processing, TSI and THI questionnaires will be filled in, a tone audiogram (TA) and DPOAE will be performed.

Intervention Type BEHAVIORAL

Other Intervention Names

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Distortion Product Otoacoustic Emission

Eligibility Criteria

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Inclusion Criteria

* adulthood (\> 18 years), tinnitus as the primary reason for referring to diagnostic processing, and consent to complete two on-site tinnitus questionnaires

Exclusion Criteria

* conductive hearing loss and incomplete questionnaires
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Sestre Milosrdnice

OTHER

Sponsor Role lead

Responsible Party

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Andro Košec, MD, PhD

Consultant Otorhinolaryngologist and Head and Neck Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Trotić, MD, PhD

Role: STUDY_CHAIR

Department of Otorhinolaryngology and Head and Neck Surgery

Locations

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University Hospital Center Sestre milosrdnice

Zagreb, , Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Andro Košec, MD, PhD

Role: CONTACT

+385989817156

Mihael Ries, MD, PhD

Role: CONTACT

+38513787430

Facility Contacts

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Andro Košec, MD, PhD

Role: primary

+385989817156

Mihael Ries, MD, PhD

Role: backup

+385989817156

Other Identifiers

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EP-TINN01

Identifier Type: -

Identifier Source: org_study_id

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