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NCT Number: NCT06894927

Hearing Screening in Adults Over 50 Years Old

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.

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Key information

Conditions

Hearing Loss, Bilateral Sensorineural, Progressive Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Bilateral (Causes Other Than Tumors) Hearing Loss, Bilateral or Unilateral Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Presbyacusis Presbycusis Sensation Disorders Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Hradec Kralove, Hradec Králové, Czech Republic, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Screening HHIA questionnaire

Diagnostic Test

Completion of the abbreviated (screening) version of the standardized "HHIA" questionnaire (Czech version).

Whispered voice test

Diagnostic Test

Whispered voice test conducted following the standardized protocol.

Screening pure tone audiometry

Diagnostic Test

Screening pure-tone audiometry at a level of 35 dB at the frequencies: 500, 1000, 2000, and 4000 Hz.

Pure Tone Audiometry

Diagnostic Test

Clinical Pure Tone Audiometry

Tympanometry

Diagnostic Test

Clinical Tympanometry

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Collaborators

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

Registry information

Official study title

Hearing Screening in Adults Over 50 Years Old - Pilot Study

Acronym: HSA50+

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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