Clinical trial NCT04775810: Study of a Signal-processing Algorithm Aiming at Improving Speech-in-noise Intelligibility in Normal-hearing and Hearing-impaired Persons
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
Overall status: UNKNOWN
Phase: NA
Conditions: Speech Intelligibility in Noise
Lead sponsor: Archean Technologies
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Speech-in-noise word identification
timeFrame: during procedure, T1
Secondary outcomes:
measure: Listening effort
timeFrame: during procedure, T1
measure: Listening effort
timeFrame: during procedure, T1
measure: Subjective preference in terms of speech naturalness
timeFrame: during procedure, T1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Rive Gauche
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.