ClinicalTrials.gg
RecruitingNCT07646119Updated Jun 12, 2026

Hidden Hearing Loss in Older Adults

An observational study in Hidden Hearing Loss, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
200
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hidden Hearing Loss

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Keywords

  • Cochlear Synaptopathy
  • Age-related Hearing Loss
03

In context

Presbycusis

66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.

This study's planned enrollment of 200 is above the median of 123 across 20 observational studies indexed under Presbycusis.

Browse Presbycusis studies →

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 164 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Unable to comply with or complete the study assessments;
  2. (MMSE) score \< 24 during previous health screening;
  3. Refuse to participate in the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  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.

07

Study locations

1 of 1 sites recruiting
  • Department of Otorhinolaryngology-Head and Neck Surgery, Shanghai Jiao Tong University School of Medicine, Shanghai, China
    Shanghai, Shanghai Municipality 200011, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — IPD used in the results publication will be shared.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2026; primary completion for May 2027, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 3, 2026
First posted
Jun 12, 2026
StartEst.
Jun 15, 2026
Primary completionEst.
May 1, 2027
CompletionEst.
May 30, 2027
Last update
Jun 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07646119
Responsible party
Ying Chen (Associate Chief Physician, Associate Director, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University) — Principal investigator
First posted
Jun 12, 2026
Start date
Jun 15, 2026 (estimated)
Primary completion
May 1, 2027 (estimated)
Completion
May 30, 2027 (estimated)
Last update
Jun 12, 2026

Study contacts

Rong Tian
Contact
rongtian_7@163.com
86+13718339118

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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