Hidden Hearing Loss in Older Adults

NCT07646119 | Recruiting

• 1 other identifier: SH9H-2026-T21-2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hidden Hearing Loss

Keywords

Cochlear Synaptopathy; Age-related Hearing Loss

Outcome Measures

Primary Outcomes (8)

• Conventional pure-tone audiometry (PTA) with extended high-frequency (0.25-16 kHz)

  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)

  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)

  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

  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)

  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)

  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

  Participants will complete all study assessments within one month of enrollment

• Central neural activity during listening task measured by fMRI

  Participants will complete all study assessments within one month of enrollment.

Secondary Outcomes (3)

• Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9)

  Participants will complete all study assessments within one month of enrollment

• Anxiety symptoms assessed using the Generalized Anxiety Disorder-7 (GAD-7)

  Participants will complete all study assessments within one month of enrollment.

• Cognitive function assessed using Digit Span test.

  Participants will complete all study assessments within one month of enrollment.

Study Arms (1)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Department of Otorhinolaryngology-Head and Neck Surgery, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Hidden; Presbycusis

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Loss, Sensorineural

Central Study Contacts

Rong Tian

CONTACT

86+13718339118; rongtian_7@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Associate Director

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 12, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available for 5 years following publication.

Locations

CN (1)