CClinicalTrials.gg
Status unknownNCT04162405Updated Nov 20, 2019

Tinnitus in Patients With and Without Sensorineural Hearing Loss

An observational study in Tinnitus, Subjective, Hearing Loss and Otorhinolaryngologic Diseases, sponsored by University Hospital Sestre Milosrdnice. Status unknown at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-20.

Sponsored by University Hospital Sestre Milosrdnice · Observational

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Tinnitus, Subjective
  • Hearing Loss
  • Otorhinolaryngologic Diseases

Keywords

  • tinnitus
  • sensorineural hearing loss
  • otoacoustic emission
  • normacusis
  • questionnaire
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's planned enrollment of 150 is above the median of 87 across 270 observational studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

University Hospital Sestre Milosrdnice is the lead sponsor of 27 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with and without hearing loss suffering from tinnitus, scheduled for diagnostic in a tertiary audiological center.

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

Exclusion Criteria:

  • conductive hearing loss and incomplete questionnaires
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with tinnitus and hearing loss

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

    Behavioral: Tinnitus Handicap Inventory Test

  • Patients with tinnitus without hearing loss

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

    Behavioral: Tinnitus Handicap Inventory Test

Interventions

  • BehavioralTinnitus 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.

    Also known as: Distortion Product Otoacoustic Emission

06

What researchers measure

Primary outcomes

  1. Establishing correlations between DPOAE, TA, and THI values

    Evaluating whethere there are certain characteristics of tinnitus correlated with patients with and without hearing loss

    Time frame: 2 hours

07

Study locations

1 of 1 sites recruiting
  • University Hospital Center Sestre milosrdnice
    Zagreb, 10000, Croatia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04162405
Lead sponsor
University Hospital Sestre Milosrdnice
Responsible party
Andro Košec, MD, PhD (Consultant Otorhinolaryngologist and Head and Neck Surgeon, University Hospital Sestre Milosrdnice) — Principal investigator
First posted
Nov 14, 2019
Start date
Nov 1, 2019
Primary completion
Jun 30, 2020 (estimated)
Completion
Jul 1, 2020 (estimated)
Last update
Nov 20, 2019

Study contacts

Andro Košec, MD, PhD
Contact
andro.kosec@yahoo.com
+385989817156
Mihael Ries, MD, PhD
Contact
miskories@gmail.com
+38513787430
Robert Trotić, MD, PhD
study chair · Department of Otorhinolaryngology and Head and Neck Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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