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

University Hospital Hradec Kralove

Status: Invitation-only

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

Treatments: Diagnostic Test: Screening pure tone audiometry; Diagnostic Test: Whispered voice test; Diagnostic Test: Tympanometry; Diagnostic Test: Pure Tone Audiometry; Diagnostic Test: Screening HHIA questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT06894927

202501 P01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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330 participants in 1 patient group

Participants

Experimental group

Description:

Participants over 50 years old.

Treatment:

Diagnostic Test: Screening HHIA questionnaire

Diagnostic Test: Pure Tone Audiometry

Diagnostic Test: Tympanometry

Diagnostic Test: Whispered voice test

Diagnostic Test: Screening pure tone audiometry