- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07646119
Hidden Hearing Loss in Older Adults
Hidden Hearing Loss in Older Adults: Mechanisms of Speech-in-noise Perception Deficits and Associated Central Compensation
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rong Tian
- Phone Number: 86+13718339118
- Email: rongtian_7@163.com
Study Locations
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200011
- Recruiting
- Department of Otorhinolaryngology-Head and Neck Surgery, Shanghai Jiao Tong University School of Medicine, Shanghai, China
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Contact:
- Rong Tian
- Phone Number: 86+13718339118
- Email: rongtian_7@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Conventional pure-tone audiometry (PTA) with extended high-frequency (0.25-16 kHz)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 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)
Time Frame: 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.
Time Frame: 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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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SH9H-2026-T21-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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