Clinical trial NCT06894927: Hearing Screening in Adults Over 50 Years Old
Official title: Hearing Screening in Adults Over 50 Years Old - Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
Collaborators: name: The Society of General Practice, J. E. Purkyne Czech Medical Association
name: Hospital Pardubice
First posted: 2025-03-25
Enrollment: 330
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm quasi-experimental study
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Hearing Loss Detected by Pure-tone Screening Audiometry
timeFrame: From enrollment by the general practitioner to ENT examination, up to 4 weeks.
measure: Number of Participants with Hearing Loss Detected by Whisper Test
timeFrame: From enrollment by the general practitioner to ENT examination, up to 4 weeks.
measure: Number of Participants with Hearing Loss Detected by the HHIA Questionnaire
timeFrame: From enrollment by the general practitioner to ENT examination, up to 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
state: Czech Republic
city: Pardubice
country: Czechia
facility: Pardubice Hospital
state: Czech Republic
Study officials:
affiliation: University Hospital Hradec Kralove
name: Viktor Chrobok, prof., M.D., CSc., Ph.D.
role: STUDY_CHAIR
affiliation: University Hospital Hradec Kralove
name: MUDr. Michal Homoláč
role: PRINCIPAL_INVESTIGATOR
References:
citation: WORLD HEALTH ORGANIZATION. Hearing Screening Considerations For Implementation. World Health Organization. 2021, 1-64.