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

November 14, 2022 updated by: Archean Technologies

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech-in-noise word identification
Time Frame: during procedure, T1
Speech-in-noise word identification score as assessed using the FrMatrix test
during procedure, T1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Listening effort
Time Frame: during procedure, T1
response times recorded during the FrMatrix test
during procedure, T1
Listening effort
Time Frame: during procedure, T1
self-assessed subjective measures of listening effort.
during procedure, T1
Subjective preference in terms of speech naturalness
Time Frame: during procedure, T1
Measures of relative preference using forced-choice pairwise comparisons
during procedure, T1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Archean Technologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 12, 2021

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (ACTUAL)

March 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUDIOCAP_CT01
  • 2020-A02253-36 (OTHER: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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