SurditySURDICACHNCT07738549
Diagnosis of Hidden Hearing Loss in Adults : Refining the Audiological Profile for Better Diagnosis.
A study testing Audiometric tests in people with Surdity and the Audiological and Electrophysiological Profile of Hidden Hearing Loss, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This study aims to investigate the underlying mechanisms of speech-in-noise difficulties in patients with normal conventional pure-tone and speech audiometry. Participants presenting with complaints of impaired speech understanding in noisy environments will undergo a comprehensive audiological assessment, including… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surdity, the Audiological and Electrophysiological Profile of Hidden Hearing Loss
- What is being tested?
- Audiometric tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2026to 1 Jul 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (age > 18 years). Patients affiliated with a social security/health insurance system. Patients consulting the ENT department for hearing difficulties despite normal conventional pure-tone and speech audiometry performed in quiet.
- Patients whose native language is French. Patients who have received oral and written information about the study and have provided free and informed consent.
- Normal otoscopic examination:
- No external auditory canal obstruction. No history of middle ear surgery (except childhood tympanostomy tube placement).
- Presence of a translucent tympanic membrane in at least one quadrant, with no tympanic membrane perforation.
- No signs of active otitis infection. No signs of cholesteatoma. Well-ventilated middle ear cavity confirmed by conventional tympanometry at 226 Hz.
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- Inclusion criteria for the control group:
- Adult patients aged between 18 and 25 years. Patients seen during an ENT consultation at Clermont-Ferrand University Hospital, without any hearing complaints.
- Patients with normal conventional pure-tone audiometry performed in quiet, defined as hearing thresholds between 0 and 20 dB HL across frequencies from 0.25 to 8 kHz, according to BIAP 2017 criteria.
- No selection bias is expected, as normal hearing is defined as hearing thresholds between 0 and 20 dB HL (BIAP 2017). This age range was selected because it provides the highest likelihood of including individuals with normal auditory function.
- -Exclusion criteria :
- Patients under legal guardianship, curatorship, judicial protection, or deprived of liberty.
- Pregnant or breastfeeding women. History of language disorders.
- Abnormal pure-tone audiometry in quiet, defined as:
- Mean pure-tone hearing loss > 20 dB HL, or At least one frequency threshold > 20 dB HL.
- Abnormal speech audiometry, defined as:
- Speech reception threshold on Lafon disyllabic word lists (male voice) > 20 dB HL, and/or Maximum speech intelligibility score of 100% obtained at a level > 40 dB HL. Refusal to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to investigate the underlying mechanisms of speech-in-noise difficulties in patients with normal conventional pure-tone and speech audiometry. Participants presenting with complaints of impaired speech understanding in noisy environments will undergo a comprehensive audiological assessment, including extended high-frequency audiometry, electrocochleography (EcoG), distortion product otoacoustic emissions (DPOAEs), auditory brainstem responses (ABR), and central auditory processing evaluation. The study seeks to identify cochlear, neural, and central auditory abnormalities that may contribute to hidden hearing loss and improve its clinical characterization.
- Being tested
- Audiometric tests
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiometric testsDiagnostic test
Audiological and electrophysiological tests will be performed in patients presenting with complaints of hearing difficulties in noisy environments despite normal pure-tone and speech audiometry in quiet.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Patients group | Experimental | Not described Receives: Diagnostic Test: Audiometric tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure-tone audiometry (air and bone conduction)
Measured: 5 minutes
Speech audiometry in quiet
Measured: 10 minutes
Framatrix® test (Interacoustics)
Measured: 15 min
Transient-evoked otoacoustic emissions (TEOAEs)
Measured: 2 min
Distortion product otoacoustic emissions (DPOAEs)
Measured: 5 minutes
Electrocochleography
Measured: 10 minutes
Auditory brainstem responses (ABR)
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurdityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathilde PUECHMAILLE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738549
- Sponsor's protocol ID
- AOI 2023 PUECHMAILLE
- Other IDs
- 2025-A01827-42
- Acronym
- SURDICACH
- Status last verified
- Jun 2026
- First submitted
- 27 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Hidden Hearing Loss in Adults : Refining the Audiological Profile for Better Diagnosis.
- ClinicalTrials.gov ID
- NCT07738549
- Acronym / sponsor ID
- SURDICACH / AOI 2023 PUECHMAILLE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 31 Jul 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.
This study aims to investigate the underlying mechanisms of speech-in-noise difficulties in patients with normal conventional pure-tone and speech audiometry. Participants presenting with complaints of impaired speech understanding in noisy environments will undergo a comprehensive audiological assessment, including extended high-frequency audiometry, electrocochleography (EcoG), distortion product otoacoustic emissions (DPOAEs), auditory brainstem responses (ABR), and central auditory processing evaluation. The study seeks to identify cochlear, neural, and central auditory abnormalities that may contribute to hidden hearing loss and improve its clinical characterization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Patients group | Experimental | Diagnostic Test: Audiometric tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Adult patients (age > 18 years). Patients affiliated with a social security/health insurance system. Patients consulting the ENT department for hearing difficulties despite normal conventional pure-tone and speech audiometry performed in quiet.
- Patients whose native language is French. Patients who have received oral and written information about the study and have provided free and informed consent.
- No external auditory canal obstruction. No history of middle ear surgery (except childhood tympanostomy tube placement).
- Presence of a translucent tympanic membrane in at least one quadrant, with no tympanic membrane perforation.
- No signs of active otitis infection. No signs of cholesteatoma. Well-ventilated middle ear cavity confirmed by conventional tympanometry at 226 Hz.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiometric testsAudiological and electrophysiological tests will be performed in patients presenting with complaints of hearing difficulties in noisy environments despite normal pure-tone and speech audiometry in quiet. | Diagnostic test | Patients group |
Primary outcome
Pure-tone audiometry (air and bone conduction)
Time frame: 5 minutes
Speech audiometry in quiet
Time frame: 10 minutes
Framatrix® test (Interacoustics)
Time frame: 15 min
Transient-evoked otoacoustic emissions (TEOAEs)
Time frame: 2 min
Distortion product otoacoustic emissions (DPOAEs)
Time frame: 5 minutes
Electrocochleography
Time frame: 10 minutes
Auditory brainstem responses (ABR)
Time frame: 10 min
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 31 Jul 2026.
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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.
Mathilde PUECHMAILLE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiometric tests in people with Surdity and the Audiological and Electrophysiological Profile of Hidden Hearing Loss, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 17 inclusion and 0 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: opening soon, as of the sponsor's last update on 31 Jul 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 France. 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 Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure-tone audiometry (air and bone conduction) (time frame: 5 minutes). The study lists 7 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 31 Jul 2026.