Hidden Hearing LossNCT07646119
Hidden Hearing Loss in Older Adults
An observational study of Hidden Hearing Loss, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hidden Hearing Loss
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Otorhinolaryngology-Head and Neck Surgery, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Shanghai, Shanghai Municipality, 200011
Rong Tian, 86+13718339118, rongtian_7@163.com
About this study
Official title: Hidden Hearing Loss in Older Adults: Mechanisms of Speech-in-noise Perception Deficits and Associated Central Compensation
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.
- Conditions
- Hidden Hearing Loss
- Keywords
- Cochlear Synaptopathy, Age-related Hearing Loss
- Medical subject headings
- Hearing Loss, Hidden, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Participants will complete all study assessments within one month of enrollment.
Central neural activity during Memory task measured by fMRI
Measured: Participants will complete all study assessments within one month of enrollment
Central neural activity during listening task measured by fMRI
Measured: 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)
Measured: Participants will complete all study assessments within one month of enrollment
Anxiety symptoms assessed using the Generalized Anxiety Disorder-7 (GAD-7)
Measured: Participants will complete all study assessments within one month of enrollment.
Cognitive function assessed using Digit Span test.
Measured: Participants will complete all study assessments within one month of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidden Hearing LossStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Chen, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646119
- Sponsor's protocol ID
- SH9H-2026-T21-2
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hidden Hearing Loss in Older Adults: Mechanisms of Speech-in-noise Perception Deficits and Associated Central Compensation
- ClinicalTrials.gov ID
- NCT07646119
- Acronym / sponsor ID
- SH9H-2026-T21-2
- Conditions
- Hidden Hearing Loss
- Keywords
- Cochlear Synaptopathy, Age-related Hearing Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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.
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.
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.
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.
Central neural activity during Memory task measured by fMRI
Time frame: Participants will complete all study assessments within one month of enrollment
Central neural activity during listening task measured by fMRI
Time frame: Participants will complete all study assessments within one month of enrollment.
3 secondary outcomes
Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Participants will complete all study assessments within one month of enrollment
Anxiety symptoms assessed using the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Participants will complete all study assessments within one month of enrollment.
Cognitive function assessed using Digit Span test.
Time frame: Participants will complete all study assessments within one month of enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Yes. IPD used in the results publication will be shared.
Related trials for Hidden Hearing Loss
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A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1/2
A Study Testing Safety and Efficacy of Transtympanic Paliroden for the Treatment of Cochlear Synaptopathy in Participants With Chronic, Constant Tinnitus
Tinnitus, Bilateral, Cochlear Synaptopathy
Not yet recruitingObservational study
Genetic Study of OTOF- Related Auditory Neuropathy Spectrum Disorder
Auditory Neuropathy Spectrum Disorder, Auditory Neuropathy
Not yet recruiting
Diagnosis of Hidden Hearing Loss in Adults : Refining the Audiological Profile for Better Diagnosis.
Surdity, the Audiological and Electrophysiological Profile of Hidden Hearing Loss
Recruiting
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Noise Exposure, Noise-induced Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hidden Hearing Loss, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Tian (86+13718339118, rongtian_7@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.