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Speech Intelligibility in NoiseAUDIOCAP 1NCT04775810

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

A study testing The device is an algorithm designed to enhance speech intelligibility of speech-in-noise signals in people with Speech Intelligibility in Noise, run by Archean Technologies at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Speech Intelligibility in Noise
What is being tested?
The device is an algorithm designed to enhance speech intelligibility of speech-in-noise signals
Type of treatment
Medical device
How many people
60 participants
Where
1 siteFrance
Study dates
12 Oct 2021to Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Lionel Fontant, Ph.D contact

+33 (0)5 63 93 50 00

lfontan@archean.tech

France1 site, 1 recruiting

  • Clinique Rive Gauche

    Toulouse, 31300

    CULINE DRI Laurence, 0561774713, l.culine@clinique-rivegauche.fr

    Recruiting

Other trials in France

About this study

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

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.

Being tested
The device is an algorithm designed to enhance speech intelligibility of speech-in-noise signals

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The device is an algorithm designed to enhance speech intelligibility of speech-in-noise signalsDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Speech-in-noise word identification

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

    Measured: during procedure, T1

Secondary outcomes (3)

  1. Listening effort

    response times recorded during the FrMatrix test

    Measured: during procedure, T1

  2. Listening effort

    self-assessed subjective measures of listening effort.

    Measured: during procedure, T1

  3. Subjective preference in terms of speech naturalness

    Measures of relative preference using forced-choice pairwise comparisons

    Measured: during procedure, T1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2021
  2. Study start12 Oct 2021
  3. Primary completionJan 2023 (estimated)
  4. Study completionJan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04775810
Sponsor's protocol ID
AUDIOCAP_CT01
Other IDs
2020-A02253-36
Acronym
AUDIOCAP 1
Status last verified
Nov 2022
First submitted
22 Feb 2021
Last updated
17 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26480972

  • 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.

    PubMed 16295234

  • 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.

    PubMed 29072542

  • 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.

    PubMed 22791988

  • 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.

    PubMed 21035629

  • 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.

    PubMed 25669761

  • 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.

    PubMed 22122354

  • 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.

    PubMed 29049622

  • 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.

    PubMed 31502900

  • 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.

    PubMed 28735855

  • 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.

    PubMed 24028365

  • 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.

    PubMed 24384545

  • 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.

    PubMed 21285878

  • 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.

    PubMed 26624277

  • 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.

    PubMed 27670209

Questions about this trial

What is this clinical trial studying?

A study testing The device is an algorithm designed to enhance speech intelligibility of speech-in-noise signals in people with Speech Intelligibility in Noise, run by Archean Technologies at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lionel Fontant, Ph.D (+33 (0)5 63 93 50 00, lfontan@archean.tech), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speech-in-noise word identification (time frame: during procedure, T1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04775810, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.

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