Tinnitus in Patients With and Without Sensorineural Hearing Loss
Characteristics of Tinnitus in Patients With and Without Sensorineural Hearing Loss: A Matched Pair Analysis
1 other identifier
observational
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 11, 2019
CompletedFirst Posted
Study publicly available on registry
November 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedNovember 20, 2019
November 1, 2019
8 months
November 11, 2019
November 18, 2019
Conditions
Keywords
Outcome Measures
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
2 hours
Study Arms (2)
Patients with tinnitus and hearing loss
Patients with tinnitus and average speech-frequency tonal audiogram threshold \>30 dB
Patients with tinnitus without hearing loss
Patients with tinnitus and average speech-frequency tonal audiogram threshold \<30 dB
Interventions
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.
Eligibility Criteria
Patients with and without hearing loss suffering from tinnitus, scheduled for diagnostic in a tertiary audiological center.
You may qualify if:
- adulthood (\> 18 years), tinnitus as the primary reason for referring to diagnostic processing, and consent to complete two on-site tinnitus questionnaires
You may not qualify if:
- conductive hearing loss and incomplete questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Center Sestre milosrdnice
Zagreb, 10000, Croatia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert Trotić, MD, PhD
Department of Otorhinolaryngology and Head and Neck Surgery
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Otorhinolaryngologist and Head and Neck Surgeon
Study Record Dates
First Submitted
November 11, 2019
First Posted
November 14, 2019
Study Start
November 1, 2019
Primary Completion
June 30, 2020
Study Completion
July 1, 2020
Last Updated
November 20, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share