- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07646119
Hidden Hearing Loss in Older Adults
Hidden Hearing Loss in Older Adults: Mechanisms of Speech-in-noise Perception Deficits and Associated Central Compensation
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Rong Tian
- Telefonnummer: 86+13718339118
- E-mail: rongtian_7@163.com
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200011
- Rekruttering
- Department of Otorhinolaryngology-Head and Neck Surgery, Shanghai Jiao Tong University School of Medicine, Shanghai, China
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Kontakt:
- Rong Tian
- Telefonnummer: 86+13718339118
- E-mail: rongtian_7@163.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Conventional pure-tone audiometry (PTA) with extended high-frequency (0.25-16 kHz)
Tidsramme: Participants will complete all study assessments within one month of enrollment.
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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.
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Participants will complete all study assessments within one month of enrollment.
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Gap Detection Test (GDT)
Tidsramme: Participants will complete all study assessments within one month of enrollment.
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This behavioral test assesses an individual's ability to detect brief silent gaps in an auditory signal, reflecting temporal resolution within the auditory system
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Participants will complete all study assessments within one month of enrollment.
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Distortion Product Otoacoustic Emissions (DPOAEs)
Tidsramme: Participants will complete all study assessments within one month of enrollment.
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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.
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Participants will complete all study assessments within one month of enrollment.
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Electrocochleography
Tidsramme: Participants will complete all study assessments within one month of enrollment.
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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.
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Participants will complete all study assessments within one month of enrollment.
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Auditory Brainstem Response (ABR)
Tidsramme: Participants will complete all study assessments within one month of enrollment.
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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.
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Participants will complete all study assessments within one month of enrollment.
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Frequency-Following Response (FFR)
Tidsramme: Participants will complete all study assessments within one month of enrollment.
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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.
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Participants will complete all study assessments within one month of enrollment.
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Central neural activity during Memory task measured by fMRI
Tidsramme: Participants will complete all study assessments within one month of enrollment
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Participants will complete all study assessments within one month of enrollment
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Central neural activity during listening task measured by fMRI
Tidsramme: Participants will complete all study assessments within one month of enrollment.
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Participants will complete all study assessments within one month of enrollment.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: Participants will complete all study assessments within one month of enrollment
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Participants will complete all study assessments within one month of enrollment
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Anxiety symptoms assessed using the Generalized Anxiety Disorder-7 (GAD-7)
Tidsramme: Participants will complete all study assessments within one month of enrollment.
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Participants will complete all study assessments within one month of enrollment.
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Cognitive function assessed using Digit Span test.
Tidsramme: Participants will complete all study assessments within one month of enrollment.
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Participants will complete all study assessments within one month of enrollment.
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SH9H-2026-T21-2
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
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Kliniske forsøg med Skjult høretab
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Institute of Hematology & Blood Diseases HospitalIkke rekrutterer endnuEffektiviteten og sikkerheden af humaniseret CD25-antistof i aGVHD-profylakse blandt ældre patienter efter HID-HSCT