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Study of a Signal-processing Algorithm Aiming at Improving Speech-in-noise Intelligibility in Normal-hearing and Hearing-impaired Persons (AUDIOCAP 1)

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ClinicalTrials.gov Identifier: NCT04775810
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
Archean Technologies

Study Description
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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.


Condition or disease Intervention/treatment Phase
Speech Intelligibility in Noise Device: The device is an algorithm designed to enhance speech intelligibility of speech-in-noise signals Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of a Signal-processing Algorithm Aiming at Improving Speech-in-noise Intelligibility in Normal-hearing and Hearing-impaired Persons
Actual Study Start Date : October 12, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Device: The 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.

Outcome Measures
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Primary Outcome Measures :
  1. Speech-in-noise word identification [ Time Frame: during procedure, T1 ]
    Speech-in-noise word identification score as assessed using the FrMatrix test


Secondary Outcome Measures :
  1. Listening effort [ Time Frame: during procedure, T1 ]
    response times recorded during the FrMatrix test

  2. Listening effort [ Time Frame: during procedure, T1 ]
    self-assessed subjective measures of listening effort.

  3. Subjective preference in terms of speech naturalness [ Time Frame: during procedure, T1 ]
    Measures of relative preference using forced-choice pairwise comparisons


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775810


Contacts
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Contact: Lionel Fontant, Ph.D +33 (0)5 63 93 50 00 lfontan@archean.tech

Locations
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France
Clinique Rive Gauche Recruiting
Toulouse, France, 31300
Contact: CULINE DRI Laurence    0561774713    l.culine@clinique-rivegauche.fr   
Sponsors and Collaborators
Archean Technologies
More Information
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Additional Information:

Publications:

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Responsible Party: Archean Technologies
ClinicalTrials.gov Identifier: NCT04775810    
Other Study ID Numbers: AUDIOCAP_CT01
2020-A02253-36 ( Other Identifier: ID-RCB )
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases