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Hearing Screening in Adults Over 50 Years Old

Hearing Screening in Adults Over 50 Years Old - Pilot Study

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06894927
Acronym
HSA50+
Enrollment
330
Registered
2025-03-25
Start date
2025-01-01
Completion date
2025-06-30
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

screening, hearing loss, adults, older, presbyacusis

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.

Interventions

DIAGNOSTIC_TESTScreening HHIA questionnaire

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

DIAGNOSTIC_TESTWhispered voice test

Whispered voice test conducted following the standardized protocol.

DIAGNOSTIC_TESTScreening pure tone audiometry

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

DIAGNOSTIC_TESTPure Tone Audiometry

Clinical Pure Tone Audiometry

DIAGNOSTIC_TESTTympanometry

Clinical Tympanometry

Sponsors

The Society of General Practice, J. E. Purkyne Czech Medical Association
CollaboratorUNKNOWN
Hospital Pardubice
CollaboratorUNKNOWN
University Hospital Hradec Kralove
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention model description

single-arm quasi-experimental study

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Hearing Loss Detected by Pure-tone Screening AudiometryFrom enrollment by the general practitioner to ENT examination, up to 4 weeks.This outcome measure evaluates the effectiveness of screening pure-tone audiometry at 35 dB at specific frequencies (500, 1000, 2000, and 4000 Hz) to detect hearing loss. Results will be compared to the reference standard (pure-tone audiometry performed at ENT clinics), calculating sensitivity, specificity, and agreement.
Number of Participants with Hearing Loss Detected by Whisper TestFrom enrollment by the general practitioner to ENT examination, up to 4 weeks.This outcome measure assesses the effectiveness of the whispered voice test in detecting hearing loss. Results will be compared with the reference standard (pure-tone audiometry performed at ENT clinics), evaluating sensitivity, specificity, and overall agreement.
Number of Participants with Hearing Loss Detected by the HHIA QuestionnaireFrom enrollment by the general practitioner to ENT examination, up to 4 weeks.This outcome measure evaluates the effectiveness of the abbreviated Hearing Handicap Inventory for Adults (HHIA) questionnaire in identifying hearing loss. Results will be validated against the reference standard (pure-tone audiometry performed at ENT clinics), assessing sensitivity, specificity, and agreement.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026