Hearing Screening in Adults Over 50 Years Old

Not Applicable

• Conditions: Hearing Loss, Bilateral Sensorineural, Progressive; Hearing Loss, Bilateral (Causes Other Than Tumors); Hearing Loss, Bilateral or Unilateral; Presbyacusis

• Registration Number: NCT06894927
• Lead Sponsor: University Hospital Hradec Kralove

Brief 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. 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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effectiveness of the Selected Hearing Screening Methods in Accurately Detecting Hearing Loss in the Target Population	From enrollment by the general practitioner to the ENT examination, up to 4 weeks.	The primary outcome measure evaluates the effectiveness of three specific hearing screening methods (pure-tone audiometry at 35 dB at 500, 1000, 2000, and 4000 Hz; whisper test; and the HHIA questionnaire) in detecting hearing loss. Results will be compared to the reference standard diagnostic method, pure-tone audiometry performed at ENT clinics, to determine sensitivity, specificity, and overall agreement. Data will be aggregated to assess the number and percentage of participants with hearing loss detected by each method and its concordance with the reference standard.

Trial Locations

Locations (2)

University Hospital Hradec Kralove; 🇨🇿 Hradec Králové, Czech Republic

Pardubice Hospital; 🇨🇿 Pardubice, Czech Republic