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NCT Number: NCT07646119

Hidden Hearing Loss in Older Adults

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, Shanghai Municipality, 200011, China

Location status: Recruiting

Location contact

Rong Tian

CONTACT

[email protected]

86+13718339118

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    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.

  2. Gap Detection Test (GDT)

    Time frame: 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

  3. Distortion Product Otoacoustic Emissions (DPOAEs)

    Time frame: 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.

  4. Electrocochleography

    Time frame: 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.

  5. Auditory Brainstem Response (ABR)

    Time frame: 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.

  6. Frequency-Following Response (FFR)

    Time frame: 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.

  7. Central neural activity during Memory task measured by fMRI

    Time frame: Participants will complete all study assessments within one month of enrollment

  8. Central neural activity during listening task measured by fMRI

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

Secondary outcomes

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

    Time frame: Participants will complete all study assessments within one month of enrollment

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

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

  3. Cognitive function assessed using Digit Span test.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rong Tian

CONTACT

[email protected]

86+13718339118

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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