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Enrolling by invitation NCT06894927

Hearing Screening in Adults Over 50 Years Old

No phase Interventional Hearing Loss, Bilateral Sensorineural, Progressive Hearing Loss, Bilateral (Causes Other Than Tumors) Hearing Loss, Bilateral or Unilateral Presbyacusis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Screening HHIA questionnaire, Whispered voice test, Screening pure tone audiometry, Pure Tone Audiometry.
Who it may be relevant to
Registry conditions: Hearing Loss, Bilateral Sensorineural, Progressive, Hearing Loss, Bilateral (Causes Other Than Tumors), Hearing Loss, Bilateral or Unilateral, Presbyacusis. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Hearing Screening in Adults Over 50 Years Old - Pilot Study

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Czechia · 2 centers
  • University Hospital Hradec Kralove — Hradec Králové
  • Pardubice Hospital — Pardubice

Publications

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

Identifiers

NCT: NCT06894927 · 202501 P01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗