NCT06894927

Hearing Screening in Adults Over 50 Years Old

Hearing Screening in Adults Over 50 Years Old - Pilot Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: University Hospital Hradec Kralove · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2025-03-25
• Last updated: 2025-05-30

Locations

2 sites across 1 country: Czechia