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Идёт набор NCT07646119

Hidden Hearing Loss in Older Adults

— Наблюдательное Hidden Hearing Loss

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Hidden Hearing Loss. Базовые параметры: от 60 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
Китай
Следующий шаг
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Официальное название

Hidden Hearing Loss in Older Adults: Mechanisms of Speech-in-noise Perception Deficits and Associated Central Compensation

Обзор

The goal of this observational study is to investigate whether speech-in-noise perception deficits in older adults aged 60 years or older with objectively normal hearing thresholds are due to impaired ability of processing temporal cues in speech signals. The study further aims to examine whether cognitive and cortical mechanisms provide compensatory support for speech perception in challenging listening environments.

Подробное описание

This observational study aims to investigate the peripheral auditory mechanisms underlying speech-in-noise perception deficits in older adults with hidden hearing loss, as well as the potential central compensatory mechanisms involved. The study will recruit community-dwelling adults aged 60 years and older who has objectively normal hearing thresholds on pure-tone audiometry but self-report difficulties understanding speech in noisy or complex listening environments.

The investigators hypothesize that speech-in-noise perception deficits in these individuals are associated with impaired ability of processing temporal cues in speech signals under challenging listening conditions. The investigators further hypothesize that cortical mechanisms involved in speech-in-noise processing may be recruited to facilitate speech understanding, although the extent of such compensation in the aging brain may vary across individuals.

The study will collect demographic, lifestyle, and health-related information. Participants will undergo comprehensive audiological assessments, neurophysiological testing, behavioral evaluations, and neuroimaging examinations. These measures will be used to characterize the ability of the peripheral auditory system to process temporal acoustic information and to investigate potential central compensatory mechanisms associated with speech perception in complex listening environments.

Первичные конечные точки

  • Conventional pure-tone audiometry (PTA) with extended high-frequency (0.25-16 kHz) [Срок оценки: Participants will complete all study assessments within one month of enrollment.]
  • Gap Detection Test (GDT) [Срок оценки: Participants will complete all study assessments within one month of enrollment.]
  • Distortion Product Otoacoustic Emissions (DPOAEs) [Срок оценки: Participants will complete all study assessments within one month of enrollment.]
  • Electrocochleography [Срок оценки: Participants will complete all study assessments within one month of enrollment.]
  • Auditory Brainstem Response (ABR) [Срок оценки: Participants will complete all study assessments within one month of enrollment.]
  • Frequency-Following Response (FFR) [Срок оценки: Participants will complete all study assessments within one month of enrollment.]
  • Central neural activity during Memory task measured by fMRI [Срок оценки: Participants will complete all study assessments within one month of enrollment]
  • Central neural activity during listening task measured by fMRI [Срок оценки: Participants will complete all study assessments within one month of enrollment.]
Вторичные конечные точки (3)
  • Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Participants will complete all study assessments within one month of enrollment]
  • Anxiety symptoms assessed using the Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Participants will complete all study assessments within one month of enrollment.]
  • Cognitive function assessed using Digit Span test. [Срок оценки: Participants will complete all study assessments within one month of enrollment.]

Критерии участия

Критерии включения

  • Aged 60 years or older;
  • Bilateral pure-tone average hearing thresholds across 0.5, 1, 2, and 4 kHz ≤ 25 dB HL;
  • Self-reported hearing difficulties identified during previous hearing screening;
  • Fluent in Mandarin Chinese;
  • No history of otologic disease, ear trauma, ototoxic medication history, or long-term noise exposure;
  • No known neurological or psychiatric disorders, or other major medical conditions that may affect nervous system function.

Критерии исключения

  • Unable to comply with or complete the study assessments;
  • Mini-Mental State Examination (MMSE) score < 24 during previous health screening;
  • Refuse to participate in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Department of Otorhinolaryngology-Head and Neck Surgery, Shanghai Jiao Tong University Sch — Шанхай

Идентификаторы

NCT: NCT07646119 · SH9H-2026-T21-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗