Tinnitus in Patients With and Without Sensorineural Hearing Loss

Hearing Loss Clinical Trial

Official title:

Characteristics of Tinnitus in Patients With and Without Sensorineural Hearing Loss: A Matched Pair Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04162405
• Other study ID #: EP-TINN01
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: November 2019
• Source: University Hospital "Sestre Milosrdnice"
• Contact: Andro Košec, MD, PhD
• Phone: +385989817156
• Email: andro.kosec[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Otorhinolaryngologic Diseases
• Tinnitus
• Tinnitus, Subjective

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Croatia	University Hospital Center Sestre milosrdnice	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital "Sestre Milosrdnice"

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishing correlations between DPOAE, TA, and THI values	Evaluating whethere there are certain characteristics of tinnitus correlated with patients with and without hearing loss	2 hours