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Study of a Signal-processing Algorithm Aiming at Improving Speech-in-noise Intelligibility in Normal-hearing and Hearing-impaired Persons

Pilot Study of a Signal-processing Algorithm Aiming at Improving Speech-in-noise Intelligibility in Normal-hearing and Hearing-impaired Persons

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04775810
Acronym
AUDIOCAP 1
Enrollment
60
Registered
2021-03-01
Start date
2021-10-12
Completion date
2023-01-31
Last updated
2022-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Speech Intelligibility in Noise

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 in noisy environments. The ability of people with ARHL to communicate is therefore greatly impacted, limiting their social interactions and thus their quality of life. Yet, the wear of hearing aids - which is the current standard rehabilitation treatment in such cases - does not lead to optimal satisfactory outcomes when it comes to understanding speech in noisy environments. The objective of this pilot study is to test a new signal-processing algorithm, based on artificial intelligence, that aims at enhancing the intelligibility of speech-in-noise signals. The efficiency of the algorithm is compared to a standard denoising algorithm commonly used in hearing aids. The primary outcome measure is the word-identification performance of the participants, using the FrMatrix test (Jansen et al., 2012). Two secondary outcome measures are investigated: listening effort (self-assessed using a Likert scale, and measured through response times), and subjective preference (assessed in a paired-comparison task). The study is conducted in 20 normal-hearing subjects and in 40 older (age ≥ 55 years) hearing-impaired subjects.

Interventions

DEVICEThe device is an algorithm designed to enhance speech intelligibility of speech-in-noise signals

Normal-hearing and hearing-impaired subjects will listen to speech-in-noise audio files that are either unprocessed or processed in order to increase speech intelligibility.

Sponsors

Archean Technologies
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Speech-in-noise word identificationduring procedure, T1Speech-in-noise word identification score as assessed using the FrMatrix test

Secondary

MeasureTime frameDescription
Listening effortduring procedure, T1response times recorded during the FrMatrix test
Subjective preference in terms of speech naturalnessduring procedure, T1Measures of relative preference using forced-choice pairwise comparisons

Countries

France

Contacts

Primary ContactLionel Fontant, Ph.D
lfontan@archean.tech+33 (0)5 63 93 50 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026