Hearing Screening in Adults Over 50 Years Old (HSA50+)

May 26, 2025 updated by: University Hospital Hradec Kralove

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?

Participants will:

  1. Undergo hearing screening using all three methods, conducted by general practitioners, to assess their performance.
  2. Complete follow-up evaluations conducted by ENT specialists to confirm diagnostic results.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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):

  1. Completion of the screening version of the standardized "HHIA" questionnaire (Czech version).
  2. Whisper test conducted following the standardized protocol.
  3. 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):

  1. Pure tone audiometry conducted following the standardized protocol.
  2. Tympanometry.

The findings will provide evidence for developing a comprehensive, national-scale hearing screening program for the aging population in the Czech Republic.

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Hradec Králové, Czech Republic, Czechia, 50005
        • University hospital Hradec Králové
      • Pardubice, Czech Republic, Czechia, 53203
        • Pardubice Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Signed informed consent (IC) and consent for personal data processing (CPDP).
  • Age 50 years or older.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants
Participants over 50 years old.
Diagnostic test: Screening HHIA questionnaire
Completion of the abbreviated (screening) version of the standardized "HHIA" questionnaire (Czech version).
Diagnostic test: Whispered voice test
Whispered voice test conducted following the standardized protocol.
Diagnostic test: Screening pure tone audiometry
Screening pure-tone audiometry at a level of 35 dB at the frequencies: 500, 1000, 2000, and 4000 Hz.
Diagnostic test: Pure Tone Audiometry
Clinical Pure Tone Audiometry
Diagnostic test: Tympanometry
Clinical Tympanometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Hearing Loss Detected by Pure-tone Screening Audiometry
Time Frame: From enrollment by the general practitioner to ENT examination, up to 4 weeks.
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.
From enrollment by the general practitioner to ENT examination, up to 4 weeks.
Number of Participants with Hearing Loss Detected by Whisper Test
Time Frame: From enrollment by the general practitioner to ENT examination, up to 4 weeks.
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.
From enrollment by the general practitioner to ENT examination, up to 4 weeks.
Number of Participants with Hearing Loss Detected by the HHIA Questionnaire
Time Frame: From enrollment by the general practitioner to ENT examination, up to 4 weeks.
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.
From enrollment by the general practitioner to ENT examination, up to 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Hradec Kralove

Collaborators

The Society of General Practice, J. E. Purkyne Czech Medical Association
Hospital Pardubice

Investigators

  • Study Chair: Viktor Chrobok, prof., M.D., CSc., Ph.D., University hospital Hradec Králové
  • Principal Investigator: MUDr. Michal Homoláč, University hospital Hradec Králové

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • WORLD HEALTH ORGANIZATION. Hearing Screening Considerations For Implementation. World Health Organization. 2021, 1-64.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202501 P01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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