Status:
UNKNOWN
Study of a Signal-processing Algorithm Aiming at Improving Speech-in-noise Intelligibility in Normal-hearing and Hearing-impaired Persons
Lead Sponsor:
Archean Technologies
Conditions:
Speech Intelligibility in Noise
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Nearly half a billion people suffer from disabling hearing loss. The most common form of hearing loss in adults is age-related hearing loss (ARHL), which causes a reduced ability to understand speech ...
Eligibility Criteria
Inclusion
- Inclusion criteria for normal-hearing participants :
- consenting to and available for the study
- age ≥ 18 years and ≤ 25 years
- right-handed
- native French speaker
- pure-tone air-conduction audiometric thresholds at .5, 1, 2, and 4 kHz all ≤ 20 dB hearing loss (HL)
- Exclusion criteria for normal-hearing participants :
- score at the Tinnitus Handicap Inventory \> 56
- uncorrected visual impairment
- pregnancy
- subject placed under legal authority (guardianship, tutorship)
- Inclusion criteria for hearing-impaired participants :
- consenting to and available for the study
- age ≥ 55 years
- native French speaker
- pure-tone air-conduction average hearing thresholds (PTA) for frequencies of .5, 1, 2, and 4 kHz ≥ 30 dB HL and ≤ 70 dB HL
- right-ear PTA for low frequencies (\< 2 kHz) lower than the right-ear PTA for high frequencies (\> 4 kHz). The difference between the two PTAs must be ≥ 20 dB
- the difference between the PTA for frequencies of .5, 1, 2, and 4 kHz (PTA.5-4kHz) in the right ear and the left-ear PTA.5-4kHz must be ≤ 10 dB
- Exclusion criteria for hearing-impaired participants :
- score at the Tinnitus Handicap Inventory \> 56
- history of a hearing impairment that was left uncorrected for more than 10 years
- uncorrected visual impairment
- congenital hearing impairment
- Ménière's disease
- auditory neuropathy
- mixed hearing loss
- fluctuating hearing impairment
- sudden hearing loss
- hearing impairment concomitant with other symptoms (e.g. vertigo)
- score at the Montreal Cognitive Assessment (MoCA) \< 27
- subject placed under legal authority (guardianship, tutorship)
Exclusion
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04775810
Start Date
October 12 2021
End Date
January 1 2023
Last Update
November 17 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinique Rive Gauche
Toulouse, France, 31300