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

NCT ID: NCT04775810

Last Updated: 2022-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-12

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Speech Intelligibility in Noise

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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)


* 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

* score at the Tinnitus Handicap Inventory \> 56
* uncorrected visual impairment
* pregnancy
* subject placed under legal authority (guardianship, tutorship)


* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Archean Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Rive Gauche

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lionel Fontant, Ph.D

Role: CONTACT

+33 (0)5 63 93 50 00

Facility Contacts

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CULINE DRI Laurence

Role: primary

0561774713

References

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Amieva H, Ouvrard C, Giulioli C, Meillon C, Rullier L, Dartigues JF. Self-Reported Hearing Loss, Hearing Aids, and Cognitive Decline in Elderly Adults: A 25-Year Study. J Am Geriatr Soc. 2015 Oct;63(10):2099-104. doi: 10.1111/jgs.13649.

Reference Type BACKGROUND
PMID: 26480972 (View on PubMed)

Bentler RA. Effectiveness of directional microphones and noise reduction schemes in hearing aids: a systematic review of the evidence. J Am Acad Audiol. 2005 Jul-Aug;16(7):473-84. doi: 10.3766/jaaa.16.7.7.

Reference Type BACKGROUND
PMID: 16295234 (View on PubMed)

Chong FY, Jenstad LM. A critical review of hearing-aid single-microphone noise-reduction studies in adults and children. Disabil Rehabil Assist Technol. 2018 Aug;13(6):600-608. doi: 10.1080/17483107.2017.1392619. Epub 2017 Oct 26.

Reference Type BACKGROUND
PMID: 29072542 (View on PubMed)

Ciorba A, Bianchini C, Pelucchi S, Pastore A. The impact of hearing loss on the quality of life of elderly adults. Clin Interv Aging. 2012;7:159-63. doi: 10.2147/CIA.S26059. Epub 2012 Jun 15.

Reference Type BACKGROUND
PMID: 22791988 (View on PubMed)

Ghulyan-Bedikian V, Paolino M, Giorgetti-D'Esclercs F, Paolino F. [Psychometric properties of a French adaptation of the Tinnitus Handicap Inventory]. Encephale. 2010 Oct;36(5):390-6. doi: 10.1016/j.encep.2009.12.007. Epub 2010 Jan 27. French.

Reference Type BACKGROUND
PMID: 21035629 (View on PubMed)

Gonthier C, Thomassin N, Roulin JL. The composite complex span: French validation of a short working memory task. Behav Res Methods. 2016 Mar;48(1):233-42. doi: 10.3758/s13428-015-0566-3.

Reference Type BACKGROUND
PMID: 25669761 (View on PubMed)

Jansen S, Luts H, Wagener KC, Kollmeier B, Del Rio M, Dauman R, James C, Fraysse B, Vormes E, Frachet B, Wouters J, van Wieringen A. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol. 2012 Mar;51(3):164-73. doi: 10.3109/14992027.2011.633568. Epub 2011 Nov 28.

Reference Type BACKGROUND
PMID: 22122354 (View on PubMed)

Krueger M, Schulte M, Zokoll MA, Wagener KC, Meis M, Brand T, Holube I. Relation Between Listening Effort and Speech Intelligibility in Noise. Am J Audiol. 2017 Oct 12;26(3S):378-392. doi: 10.1044/2017_AJA-16-0136.

Reference Type BACKGROUND
PMID: 29049622 (View on PubMed)

Lakshmi MSK, Rout A, O'Donoghue CR. A systematic review and meta-analysis of digital noise reduction hearing aids in adults. Disabil Rehabil Assist Technol. 2021 Feb;16(2):120-129. doi: 10.1080/17483107.2019.1642394. Epub 2019 Sep 10.

Reference Type BACKGROUND
PMID: 31502900 (View on PubMed)

Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available.

Reference Type BACKGROUND
PMID: 28735855 (View on PubMed)

Mener DJ, Betz J, Genther DJ, Chen D, Lin FR. Hearing loss and depression in older adults. J Am Geriatr Soc. 2013 Sep;61(9):1627-9. doi: 10.1111/jgs.12429. No abstract available.

Reference Type BACKGROUND
PMID: 24028365 (View on PubMed)

Mick P, Kawachi I, Lin FR. The association between hearing loss and social isolation in older adults. Otolaryngol Head Neck Surg. 2014 Mar;150(3):378-84. doi: 10.1177/0194599813518021. Epub 2014 Jan 2.

Reference Type BACKGROUND
PMID: 24384545 (View on PubMed)

Moore BC, Fullgrabe C, Stone MA. Determination of preferred parameters for multichannel compression using individually fitted simulated hearing AIDS and paired comparisons. Ear Hear. 2011 Sep-Oct;32(5):556-68. doi: 10.1097/AUD.0b013e31820b5f4c.

Reference Type BACKGROUND
PMID: 21285878 (View on PubMed)

Moulin A, Richard C. Sources of variability of speech, spatial, and qualities of hearing scale (SSQ) scores in normal-hearing and hearing-impaired populations. Int J Audiol. 2016;55(2):101-9. doi: 10.3109/14992027.2015.1104734. Epub 2015 Dec 1.

Reference Type BACKGROUND
PMID: 26624277 (View on PubMed)

Nasreddine ZS, Patel BB. Validation of Montreal Cognitive Assessment, MoCA, Alternate French Versions. Can J Neurol Sci. 2016 Sep;43(5):665-71. doi: 10.1017/cjn.2016.273.

Reference Type BACKGROUND
PMID: 27670209 (View on PubMed)

Neher T, Grimm G, Hohmann V, Kollmeier B. Do hearing loss and cognitive function modulate benefit from different binaural noise-reduction settings? Ear Hear. 2014 May-Jun;35(3):e52-62. doi: 10.1097/AUD.0000000000000003.

Reference Type BACKGROUND
PMID: 24351610 (View on PubMed)

Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. doi: 10.1016/0028-3932(71)90067-4. No abstract available.

Reference Type BACKGROUND
PMID: 5146491 (View on PubMed)

Related Links

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https://apps.who.int/iris/bitstream/handle/10665/254659/9789241512046-eng.pdf

WHO (2017). Global costs of unaddressed hearing loss and cost-effectiveness of interventions

Other Identifiers

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2020-A02253-36

Identifier Type: OTHER

Identifier Source: secondary_id

AUDIOCAP_CT01

Identifier Type: -

Identifier Source: org_study_id

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