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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)

Primary Purpose

Speech Intelligibility in Noise

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The device is an algorithm designed to enhance speech intelligibility of speech-in-noise signals
Sponsored by
Archean Technologies
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Speech Intelligibility in Noise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Clinique Rive GaucheRecruiting

Outcomes

Primary Outcome Measures

Speech-in-noise word identification
Speech-in-noise word identification score as assessed using the FrMatrix test

Secondary Outcome Measures

Listening effort
response times recorded during the FrMatrix test
Listening effort
self-assessed subjective measures of listening effort.
Subjective preference in terms of speech naturalness
Measures of relative preference using forced-choice pairwise comparisons

Full Information

First Posted
February 22, 2021
Last Updated
November 14, 2022
Sponsor
Archean Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT04775810
Brief Title
Study of a Signal-processing Algorithm Aiming at Improving Speech-in-noise Intelligibility in Normal-hearing and Hearing-impaired Persons
Acronym
AUDIOCAP 1
Official Title
Pilot Study of a Signal-processing Algorithm Aiming at Improving Speech-in-noise Intelligibility in Normal-hearing and Hearing-impaired Persons
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Archean Technologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech Intelligibility in Noise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
The device is an algorithm designed to enhance speech intelligibility of speech-in-noise signals
Intervention Description
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.
Primary Outcome Measure Information:
Title
Speech-in-noise word identification
Description
Speech-in-noise word identification score as assessed using the FrMatrix test
Time Frame
during procedure, T1
Secondary Outcome Measure Information:
Title
Listening effort
Description
response times recorded during the FrMatrix test
Time Frame
during procedure, T1
Title
Listening effort
Description
self-assessed subjective measures of listening effort.
Time Frame
during procedure, T1
Title
Subjective preference in terms of speech naturalness
Description
Measures of relative preference using forced-choice pairwise comparisons
Time Frame
during procedure, T1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lionel Fontant, Ph.D
Phone
+33 (0)5 63 93 50 00
Email
lfontan@archean.tech
Facility Information:
Facility Name
Clinique Rive Gauche
City
Toulouse
ZIP/Postal Code
31300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CULINE DRI Laurence
Phone
0561774713
Email
l.culine@clinique-rivegauche.fr

12. IPD Sharing Statement

Plan to Share IPD
No
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26480972
Citation
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Links:
URL
https://www.ehima.com/wp-content/uploads/2018/07/EuroTrak_2018_FRANCE.pdf
Description
Anovum (2018). EuroTrak 2018. (Rapport).
URL
https://www.legifrance.gouv.fr/affichCode.do?idArticle=LEGIARTI000006914297&idSectionTA=LEGISCTA000006191017&cidTexte=LEGITEXT000006072665&dateTexte=20120830
Description
République Française (2017). Code de la santé publique. Audioprothésiste. Local réservé à l'activité professionnelle
URL
https://apps.who.int/iris/bitstream/handle/10665/254659/9789241512046-eng.pdf
Description
WHO (2017). Global costs of unaddressed hearing loss and cost-effectiveness of interventions
URL
https://www.who.int/news-room/fact-sheets/detail/deafness-and-hearing-loss
Description
WHO (2020). Deafness and Hearing Loss. (Rapport)

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

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