Hearing Screening in Adults Over 50 Years Old

NCT ID: NCT06894927

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Hearing Loss, Bilateral Sensorineural, Progressive Hearing Loss, Bilateral (Causes Other Than Tumors) Hearing Loss, Bilateral or Unilateral Presbyacusis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single-arm quasi-experimental study
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Participants

Participants over 50 years old.

Group Type EXPERIMENTAL

Screening HHIA questionnaire

Intervention Type DIAGNOSTIC_TEST

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

Whispered voice test

Intervention Type DIAGNOSTIC_TEST

Whispered voice test conducted following the standardized protocol.

Screening pure tone audiometry

Intervention Type DIAGNOSTIC_TEST

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

Pure Tone Audiometry

Intervention Type DIAGNOSTIC_TEST

Clinical Pure Tone Audiometry

Tympanometry

Intervention Type DIAGNOSTIC_TEST

Clinical Tympanometry

Interventions

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Screening HHIA questionnaire

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

Intervention Type DIAGNOSTIC_TEST

Whispered voice test

Whispered voice test conducted following the standardized protocol.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Pure Tone Audiometry

Clinical Pure Tone Audiometry

Intervention Type DIAGNOSTIC_TEST

Tympanometry

Clinical Tympanometry

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Hospital Pardubice

UNKNOWN

Sponsor Role collaborator

University Hospital Hradec Kralove

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Viktor Chrobok, prof., M.D., CSc., Ph.D.

Role: STUDY_CHAIR

University Hospital Hradec Kralove

MUDr. Michal Homoláč

Role: PRINCIPAL_INVESTIGATOR

University Hospital Hradec Kralove

Locations

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University Hospital Hradec Kralove

Hradec Králové, Czech Republic, Czechia

Site Status

Pardubice Hospital

Pardubice, Czech Republic, Czechia

Site Status

Countries

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Czechia

References

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

Reference Type BACKGROUND

Other Identifiers

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202501 P01

Identifier Type: -

Identifier Source: org_study_id

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