Tinnitus, SubjectiveNCT04162405
Tinnitus in Patients With and Without Sensorineural Hearing Loss
An observational study of Tinnitus, Subjective and Hearing Loss, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Subjective, Hearing Loss, Otorhinolaryngologic Diseases
- What is being tested?
- Tinnitus Handicap Inventory Test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Nov 2019to 1 Jul 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with and without hearing loss suffering from tinnitus, scheduled for diagnostic in a tertiary audiological center.
Who may be able to join
- adulthood (> 18 years), tinnitus as the primary reason for referring to diagnostic processing, and consent to complete two on-site tinnitus questionnaires
Who cannot join
- conductive hearing loss and incomplete questionnaires
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Center Sestre milosrdnice
Zagreb, 10000
Andro Košec, MD, PhD, +385989817156, andro.kosec@yahoo.com
Mihael Ries, MD, PhD, +385989817156, miskories@gmail.com
About this study
Official title: Characteristics of Tinnitus in Patients With and Without Sensorineural Hearing Loss: A Matched Pair Analysis
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.
- Being tested
- Tinnitus Handicap Inventory Test
- Keywords
- tinnitus, sensorineural hearing loss, otoacoustic emission, normacusis, questionnaire
- Medical subject headings
- Tinnitus, Hearing Loss, Otorhinolaryngologic Diseases, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinnitus Handicap Inventory TestBehavioural
Also called Distortion Product Otoacoustic Emission
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with tinnitus and hearing loss | Patients with tinnitus and average speech-frequency tonal audiogram threshold >30 dB Receives: Behavioral: Tinnitus Handicap Inventory Test | |
| Patients with tinnitus without hearing loss | Patients with tinnitus and average speech-frequency tonal audiogram threshold <30 dB Receives: Behavioral: Tinnitus Handicap Inventory Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishing correlations between DPOAE, TA, and THI values
Evaluating whethere there are certain characteristics of tinnitus correlated with patients with and without hearing loss
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start1 Nov 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion1 Jul 2020 (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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andro Košec, MD, PhD, University Hospital Sestre Milosrdnice
- Investigators
- Robert Trotić, MD, PhD, Study chair, Department of Otorhinolaryngology and Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162405
- Sponsor's protocol ID
- EP-TINN01
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2019
- Last updated
- 20 Nov 2019
- 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 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Tinnitus in Patients With and Without Sensorineural Hearing Loss: A Matched Pair Analysis
- ClinicalTrials.gov ID
- NCT04162405
- Acronym / sponsor ID
- EP-TINN01
- Keywords
- tinnitus, sensorineural hearing loss, otoacoustic emission, normacusis, questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 14 Nov 2019 (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.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with tinnitus and hearing loss | – | Behavioral: Tinnitus Handicap Inventory TestPatients with tinnitus and average speech-frequency tonal audiogram threshold >30 dB |
| Patients with tinnitus without hearing loss | – | Behavioral: Tinnitus Handicap Inventory TestPatients with tinnitus and average speech-frequency tonal audiogram threshold <30 dB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with and without hearing loss suffering from tinnitus, scheduled for diagnostic in a tertiary audiological center.
Key inclusion criteria (1 listed)
- adulthood (> 18 years), tinnitus as the primary reason for referring to diagnostic processing, and consent to complete two on-site tinnitus questionnaires
Key exclusion criteria (1 listed)
- conductive hearing loss and incomplete questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinnitus Handicap Inventory TestAlso: Distortion Product Otoacoustic EmissionA 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. | Behavioural | Patients with tinnitus and hearing loss, Patients with tinnitus without hearing loss |
Primary outcome
Establishing correlations between DPOAE, TA, and THI values
Time frame: 2 hours
Evaluating whethere there are certain characteristics of tinnitus correlated with patients with and without hearing loss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- 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.
Robert Trotić, MD, PhD study chair
Department of Otorhinolaryngology and Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, Subjective and Hearing Loss, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
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 1 inclusion and 1 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 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Andro Košec, MD, PhD (+385989817156, andro.kosec@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishing correlations between DPOAE, TA, and THI values (time frame: 2 hours). 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 20 Nov 2019.