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Hidden Hearing Loss in Older Adults

9 giugno 2026 aggiornato da: Ying Chen, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

200

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200011
        • Reclutamento
        • Department of Otorhinolaryngology-Head and Neck Surgery, Shanghai Jiao Tong University School of Medicine, Shanghai, China
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Community-dwelling adults aged 60 years and older residing in Shanghai, who has objectively normal hearing thresholds on pure-tone audiometry but self-report difficulties understanding speech in noisy or complex listening environments.

Descrizione

Inclusion Criteria:

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

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
older adults with hidden hearing loss
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Conventional pure-tone audiometry (PTA) with extended high-frequency (0.25-16 kHz)
Lasso di tempo: Participants will complete all study assessments within one month of enrollment.
This measure reflects the overall audibility of the individual. Together with the other measures listed under the primary outcome measure, it provides a comprehensive assessment of participants' peripheral auditory function.
Participants will complete all study assessments within one month of enrollment.
Gap Detection Test (GDT)
Lasso di tempo: Participants will complete all study assessments within one month of enrollment.
This behavioral test assesses an individual's ability to detect brief silent gaps in an auditory signal, reflecting temporal resolution within the auditory system
Participants will complete all study assessments within one month of enrollment.
Distortion Product Otoacoustic Emissions (DPOAEs)
Lasso di tempo: Participants will complete all study assessments within one month of enrollment.
This objective measure evaluates cochlear outer hair cell. Together with the other measures listed under the primary outcome measure, it provides a comprehensive assessment of participants' peripheral auditory function.
Participants will complete all study assessments within one month of enrollment.
Electrocochleography
Lasso di tempo: Participants will complete all study assessments within one month of enrollment.
This objective measure assesses cochlear and auditory nerve function. Together with the other measures listed under the primary outcome measure, it provides a comprehensive assessment of participants' peripheral auditory function.
Participants will complete all study assessments within one month of enrollment.
Auditory Brainstem Response (ABR)
Lasso di tempo: Participants will complete all study assessments within one month of enrollment.
This objective measure assesses auditory nerve and brainstem function. Together with the other measures listed under the primary outcome measure, it provides a comprehensive assessment of participants' peripheral auditory function.
Participants will complete all study assessments within one month of enrollment.
Frequency-Following Response (FFR)
Lasso di tempo: Participants will complete all study assessments within one month of enrollment.
This objective measure assesses the neural encoding of sound by recording phase-locked neural responses to auditory stimuli. It reflects the ability of the auditory system to encode and resolve temporal information.
Participants will complete all study assessments within one month of enrollment.
Central neural activity during Memory task measured by fMRI
Lasso di tempo: Participants will complete all study assessments within one month of enrollment
Participants will complete all study assessments within one month of enrollment
Central neural activity during listening task measured by fMRI
Lasso di tempo: Participants will complete all study assessments within one month of enrollment.
Participants will complete all study assessments within one month of enrollment.

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9)
Lasso di tempo: Participants will complete all study assessments within one month of enrollment
Participants will complete all study assessments within one month of enrollment
Anxiety symptoms assessed using the Generalized Anxiety Disorder-7 (GAD-7)
Lasso di tempo: Participants will complete all study assessments within one month of enrollment.
Participants will complete all study assessments within one month of enrollment.
Cognitive function assessed using Digit Span test.
Lasso di tempo: Participants will complete all study assessments within one month of enrollment.
Participants will complete all study assessments within one month of enrollment.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 giugno 2026

Completamento primario (Stimato)

1 maggio 2027

Completamento dello studio (Stimato)

30 maggio 2027

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2026

Primo Inserito (Effettivo)

12 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SH9H-2026-T21-2

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

IPD used in the results publication will be shared.

Periodo di condivisione IPD

IPD and supporting information will be available for 5 years following publication.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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