Hearing Screening in Adults Over 50 Years Old

NCT06894927 | Enrolling By Invitation

• 1 other identifier: 202501 P01
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 2

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. 1.Undergo hearing screening using all three methods, conducted by general practitioners, to assess their performance.
2. 2.Complete follow-up evaluations conducted by ENT specialists to confirm diagnostic results.

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

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Hearing Loss Detected by Pure-tone Screening Audiometry

  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.

  From enrollment by the general practitioner to ENT examination, up to 4 weeks.

• Number of Participants with Hearing Loss Detected by Whisper Test

  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.

  From enrollment by the general practitioner to ENT examination, up to 4 weeks.

• Number of Participants with Hearing Loss Detected by the HHIA Questionnaire

  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.

  From enrollment by the general practitioner to ENT examination, up to 4 weeks.

Study Arms (1)

Participants

EXPERIMENTAL

Participants over 50 years old.

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

Interventions

Screening HHIA questionnaire DIAGNOSTIC_TEST

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

Participants

Whispered voice test DIAGNOSTIC_TEST

Whispered voice test conducted following the standardized protocol.

Participants

Screening pure tone audiometry DIAGNOSTIC_TEST

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

Participants

Pure Tone Audiometry DIAGNOSTIC_TEST

Clinical Pure Tone Audiometry

Participants

Tympanometry DIAGNOSTIC_TEST

Clinical Tympanometry

Participants

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent (IC) and consent for personal data processing (CPDP).
• Age 50 years or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead
• The Society of General Practice, J. E. Purkyne Czech Medical Association: collaborator
• Hospital Pardubice: collaborator

Study Sites (2)

University Hospital Hradec Kralove

Hradec Králové, Czech Republic, 50005, Czechia

Location

Pardubice Hospital

Pardubice, Czech Republic, 53203, Czechia

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Hearing Loss; Presbycusis

Interventions

Audiometry, Pure-Tone; Acoustic Impedance Tests

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Loss, Sensorineural

Intervention Hierarchy (Ancestors)

Audiometry; Hearing Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

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

  University Hospital Hradec Kralove

  STUDY CHAIR

• MUDr. Michal Homoláč

  University Hospital Hradec Kralove

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-arm quasi-experimental study

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: March 25, 2025
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)