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Not yet recruiting NCT07738549

Diagnosis of Hidden Hearing Loss in Adults : Refining the Audiological Profile for Better Diagnosis.

No phase Interventional Surdity the Audiological and Electrophysiological Profile of Hidden Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Audiometric tests.
Who it may be relevant to
Registry conditions: Surdity, the Audiological and Electrophysiological Profile of Hidden Hearing Loss. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test Audiometric tests
    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.

Primary outcome measures

  • 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]

Eligibility criteria

Inclusion criteria

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.

\- 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHU Clermont-Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT07738549 · AOI 2023 PUECHMAILLE · 2025-A01827-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗