An interventional study of Screening HHIA questionnaire and Whispered voice test in Hearing Loss, Bilateral Sensorineural, Progressive, Hearing Loss, Bilateral (Causes Other Than Tumors) and Hearing Loss, Bilateral or Unilateral, sponsored by University Hospital Hradec Kralove. Enrolling by invitation at 2 sites in Czechia. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by University Hospital Hradec Kralove · Not applicable, Interventional, and Screening
The goal of this single-arm quasi-experimental study is to evaluate the feasibility, effectiveness, and management of three different hearing screening methods in adults aged 50 years and older in the Czech Republic. The main questions it aims to answer are:
Are the selected hearing screening methods effective in detecting hearing loss in the target population? Can these methods be successfully implemented within the national healthcare system to address gaps in current practices?
Participants will:
This single-arm quasi-experimental study involves a total of 330 participants aged 50 and older. The study evaluates the feasibility and effectiveness of three distinct hearing screening methods, conducted first by general practitioners and subsequently confirmed by ENT specialists, according to a standardized protocol.
Study Population and Interventions
Participants:
A total of 330 adults aged 50 years and older will be enrolled in the study.
Interventions:
The interventions are divided into two stages:
General Practitioners' Offices:
Before the screening:
Explanation of the screening process. Personal medical history review. Otoscopy and patient instruction.
Screening procedures (performed for all participants in the same order according to the standardized protocol):
ENT Clinics:
Before the evaluation:
Explanation of the evaluation process. ENT-specific medical history review. Otoscopy and patient instruction.
Diagnostic procedures (performed for all participants in the same order according to the standardized protocol):
The findings will provide evidence for developing a comprehensive, national-scale hearing screening program for the aging population in the Czech Republic.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 330 is above the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →University Hospital Hradec Kralove is the lead sponsor of 49 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants over 50 years old.
Diagnostic Test: Screening HHIA questionnaire · Diagnostic Test: Whispered voice test · Diagnostic Test: Screening pure tone audiometry · Diagnostic Test: Pure Tone Audiometry · Diagnostic Test: Tympanometry
Completion of the abbreviated (screening) version of the standardized "HHIA" questionnaire (Czech version).
Whispered voice test conducted following the standardized protocol.
Screening pure-tone audiometry at a level of 35 dB at the frequencies: 500, 1000, 2000, and 4000 Hz.
Clinical Pure Tone Audiometry
Clinical Tympanometry
Number of Participants with Hearing Loss Detected by Pure-tone Screening Audiometry
This outcome measure evaluates the effectiveness of screening pure-tone audiometry at 35 dB at specific frequencies (500, 1000, 2000, and 4000 Hz) to detect hearing loss. Results will be compared to the reference standard (pure-tone audiometry performed at ENT clinics), calculating sensitivity, specificity, and agreement.
Time frame: From enrollment by the general practitioner to ENT examination, up to 4 weeks.
Number of Participants with Hearing Loss Detected by Whisper Test
This outcome measure assesses the effectiveness of the whispered voice test in detecting hearing loss. Results will be compared with the reference standard (pure-tone audiometry performed at ENT clinics), evaluating sensitivity, specificity, and overall agreement.
Time frame: From enrollment by the general practitioner to ENT examination, up to 4 weeks.
Number of Participants with Hearing Loss Detected by the HHIA Questionnaire
This outcome measure evaluates the effectiveness of the abbreviated Hearing Handicap Inventory for Adults (HHIA) questionnaire in identifying hearing loss. Results will be validated against the reference standard (pure-tone audiometry performed at ENT clinics), assessing sensitivity, specificity, and agreement.
Time frame: From enrollment by the general practitioner to ENT examination, up to 4 weeks.
Plan to share: No
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University Hospital Hradec Kralove