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Набор по приглашению NCT06894927

Hearing Screening in Adults Over 50 Years Old

Без фазы С лечением Hearing Loss, Bilateral Sensorineural, Progressive Hearing Loss, Bilateral (Causes Other Than Tumors) Hearing Loss, Bilateral or Unilateral Presbyacusis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Screening HHIA questionnaire, Whispered voice test, Screening pure tone audiometry, Pure Tone Audiometry.
Кому может быть актуально
Состояния в реестре: Hearing Loss, Bilateral Sensorineural, Progressive, Hearing Loss, Bilateral (Causes Other Than Tumors), Hearing Loss, Bilateral or Unilateral, Presbyacusis. Базовые параметры: от 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Чехия
Следующий шаг
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Официальное название

Hearing Screening in Adults Over 50 Years Old - Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест Screening HHIA questionnaire
    Completion of the abbreviated (screening) version of the standardized "HHIA" questionnaire (Czech version).
  • Диагностический тест Whispered voice test
    Whispered voice test conducted following the standardized protocol.
  • Диагностический тест Screening pure tone audiometry
    Screening pure-tone audiometry at a level of 35 dB at the frequencies: 500, 1000, 2000, and 4000 Hz.
  • Диагностический тест Pure Tone Audiometry
    Clinical Pure Tone Audiometry
  • Диагностический тест Tympanometry
    Clinical Tympanometry

Первичные конечные точки

  • Number of Participants with Hearing Loss Detected by Pure-tone Screening Audiometry [Срок оценки: From enrollment by the general practitioner to ENT examination, up to 4 weeks.]
  • Number of Participants with Hearing Loss Detected by Whisper Test [Срок оценки: From enrollment by the general practitioner to ENT examination, up to 4 weeks.]
  • Number of Participants with Hearing Loss Detected by the HHIA Questionnaire [Срок оценки: From enrollment by the general practitioner to ENT examination, up to 4 weeks.]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

Чехия · 2 центра
  • University Hospital Hradec Kralove — Hradec Králové
  • Pardubice Hospital — Pardubice

Публикации

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

Идентификаторы

NCT: NCT06894927 · 202501 P01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗