Hearing Loss, Bilateral Sensorineural, ProgressiveHSA50+NCT06894927
Hearing Screening in Adults Over 50 Years Old
A study testing Screening HHIA questionnaire, Whispered voice test and Screening pure tone audiometry in people with Hearing Loss, Bilateral Sensorineural, Progressive and Hearing Loss, Bilateral (Causes Other Than Tumors), run by University Hospital Hradec Kralove at 2 sites in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Bilateral Sensorineural, Progressive, Hearing Loss, Bilateral (Causes Other Than Tumors), Hearing Loss, Bilateral or Unilateral
- What is being tested?
- Screening HHIA questionnaire, Whispered voice test and Screening pure tone audiometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Jan 2025to 30 Jun 2025
- Phase
- Interventional
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent (IC) and consent for personal data processing (CPDP).
- Age 50 years or older.
Who cannot join
- Known diagnosed persistent hearing impairment.
- Inability to sufficiently understand study instructions due to language barriers.
- Medical condition preventing participation in all parts of the study.
- Inability or unwillingness to complete all parts of the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia2 sites
University Hospital Hradec Kralove
Hradec Králové, Czech Republic, 50005
Pardubice Hospital
Pardubice, Czech Republic, 53203
About this study
Official title: Hearing Screening in Adults Over 50 Years Old - Pilot Study
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?
Read more
Participants will:
- Undergo hearing screening using all three methods, conducted by general practitioners, to assess their performance.
- Complete follow-up evaluations conducted by ENT specialists to confirm diagnostic results.
Read the detailed description
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):
- Completion of the screening version of the standardized "HHIA" questionnaire (Czech version).
- Whisper test conducted following the standardized protocol.
- Screening pure tone audiometry performed 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):
- Pure tone audiometry conducted following the standardized protocol.
- Tympanometry.
The findings will provide evidence for developing a comprehensive, national-scale hearing screening program for the aging population in the Czech Republic.
- Conditions
- Hearing Loss, Bilateral Sensorineural, Progressive, Hearing Loss, Bilateral (Causes Other Than Tumors), Hearing Loss, Bilateral or Unilateral, Presbyacusis
- Being tested
- Screening HHIA questionnaire, Whispered voice test, Screening pure tone audiometry, Pure Tone Audiometry, Tympanometry
- Keywords
- screening, hearing loss, adults, older, presbyacusis
- Medical subject headings
- Hearing Loss, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening HHIA questionnaireDiagnostic test
Completion of the abbreviated (screening) version of the standardized "HHIA" questionnaire (Czech version).
Whispered voice testDiagnostic test
Whispered voice test conducted following the standardized protocol.
Screening pure tone audiometryDiagnostic test
Screening pure-tone audiometry at a level of 35 dB at the frequencies: 500, 1000, 2000, and 4000 Hz.
Pure Tone AudiometryDiagnostic test
Clinical Pure Tone Audiometry
TympanometryDiagnostic test
Clinical Tympanometry
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Participants over 50 years old. Receives: Diagnostic Test: Screening HHIA questionnaire; Diagnostic Test: Whispered voice test; Diagnostic Test: Screening pure tone audiometry; Diagnostic Test: Pure Tone Audiometry; Diagnostic Test: Tympanometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment by the general practitioner to ENT examination, up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Jan 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, Bilateral Sensorineural, ProgressiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm quasi-experimental study
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Collaborators
- The Society of General Practice, J. E. Purkyne Czech Medical Association, Hospital Pardubice
- Responsible party
- Sponsor
- Investigators
- Viktor Chrobok, prof., M.D., CSc., Ph.D., Study chair, University Hospital Hradec KraloveMUDr. Michal Homoláč, Principal investigator, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894927
- Sponsor's protocol ID
- 202501 P01
- Acronym
- HSA50+
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
WORLD HEALTH ORGANIZATION. Hearing Screening Considerations For Implementation. World Health Organization. 2021, 1-64.