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Evaluation of a Digital Therapy of Auditory Training (AUDISSEE)

Primary Purpose

Hearing Loss, Age-Related

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AUDISSEE
Placebo
Sponsored by
Humans Matter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Age-Related focused on measuring Hearing aid, presbycusis, auditory training, hearing in noise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age over 18 No neurological or psychiatric background No major cognitive deficit, able to understand and apply the recommendation Motivated to participate Have given its written consent Affiliated to a social security system Diagnostic of presbycusis by a health professional Hearing-aids since less than 2 years (no cochlear implants) No tinnitus With a possible access to a personal computer, tactile tablet or smart-phone to perform the training Exclusion Criteria: Age below 18 Pregnant or breastfeeding women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Placebo Comparator

    Arm Label

    AUDISSEE-verbal, AUDISSE-non-verbal, Placebo, Placebo

    AUDISSE-non-verbal, AUDISSEE-verbal, Placebo, Placebo

    Placebo, Placebo, AUDISSEE-verbal, AUDISSE-non-verbal

    Placebo, Placebo, AUDISSE-non-verbal, AUDISSEE-verbal

    Arm Description

    In this arm, the group will perform first the AUDISSEE therapy starting with the verbal sub-training then the non-verbal sub-training. Then it will perform the placebo training for 10 weeks. The AUDISSEE therapy takes place over 10 weeks with 3 sessions of 20 minutes per week. It is divided into two parts (5 weeks for each part): verbal training exercises in noise that are specifically aimed at improving patients' intelligibility in noise non-verbal training exercises using environmental sounds and musical sounds, which are specifically aimed at improving non-verbal auditory perception

    In this arm, the group will perform first the AUDISSEE therapy starting with the non-verbal sub-training then the verbal sub-training. Then it will perform the placebo training for 10 weeks.

    In this arm, the group will perform first placebo training for 10 weeks. Then, it will perform the AUDISSEE therapy starting with the verbal sub-training then the non-verbal sub-training. At each session of the placebo therapy, the patient will listen to an excerpt from an audio-book or podcast of similar length to the duration of the training exercises (20 min). This therapy engages the patient in a similar manner than the AUDISSEE therapy in terms of time spent (same session frequency, same session duration), but does not specifically train auditory perception networks.

    In this arm, the group will perform first placebo training for 10 weeks. Then, it will perform the AUDISSEE therapy starting with the non-verbal sub-training then the verbal sub-training.

    Outcomes

    Primary Outcome Measures

    Hearing in noise
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
    Hearing in noise
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
    Hearing in noise
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
    Hearing in noise
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
    Hearing in noise
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
    Hearing in noise
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
    Hearing in noise
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
    Hearing in noise
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured

    Secondary Outcome Measures

    Quality of life and hearing : personal efficacy
    Questionnaire for the feeling of personal efficacy:14 items with a 5-pt likert scale, a mean score is measured (between 1 and 5)
    Quality of life and hearing : listening effort
    Questionnaire for the listening effort: 10 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Quality of life and hearing : spatial learning abilities
    Questionnaire for the spatial learning abilities (SSQ15): 15 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Quality of life and hearing: personal efficacy
    Questionnaire for the feeling of personal efficacy:14 items with a 5-pt likert scale, a mean score is measured (between 1 and 5)
    Quality of life and hearing: listening effort
    Questionnaire for the listening effort: 10 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Quality of life and hearing: spatial learning abilities
    Questionnaire for the spatial learning abilities (SSQ15): 15 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Quality of life and hearing: personal efficacy
    Questionnaire for the feeling of personal efficacy:14 items with a 5-pt likert scale, a mean score is measured (between 1 and 5)
    Quality of life and hearing: listening effort
    Questionnaire for the listening effort: 10 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Quality of life and hearing: spatial learning abilities
    Questionnaire for the spatial learning abilities (SSQ15): 15 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Quality of life and hearing: personal efficacy
    Questionnaire for the feeling of personal efficacy:14 items with a 5-pt likert scale, a mean score is measured (between 1 and 5)
    Quality of life and hearing: listening effort
    Questionnaire for the listening effort: 10 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Quality of life and hearing: spatial learning abilities
    Questionnaire for the spatial learning abilities (SSQ15): 15 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Non-verbal auditory testing :pitch change detection task
    Battery of listening tests for non-verbal auditory cognition assessment: - Pitch Change Detection task: percentage of correct responses
    Non-verbal auditory testing: Direction of pitch change identification task
    Battery of listening tests for non-verbal auditory cognition assessment: - Direction of pitch change identification task: percentage of correct responses
    Non-verbal auditory testing: Short term memory for pitch task
    Battery of listening tests for non-verbal auditory cognition assessment: - Short term memory for pitch task: percentage of correct responses
    Non-verbal auditory testing: Emotional prosody recognition task
    Battery of listening tests for non-verbal auditory cognition assessment: - Emotional prosody recognition task: perception of correct responses
    Non-verbal auditory testing: Auditory Streaming separation task
    Battery of listening tests for non-verbal auditory cognition assessment: - Auditory Streaming separation task: mean frequency (in Hz) of perception change between 1 and 2 streams
    Non-verbal auditory testing: Pitch Change Detection task
    Battery of listening tests for non-verbal auditory cognition assessment: - Pitch Change Detection task: percentage of correct responses
    Non-verbal auditory testing: Direction of pitch change identification task
    Battery of listening tests for non-verbal auditory cognition assessment: - Direction of pitch change identification task: percentage of correct responses
    Non-verbal auditory testing: Short term memory for pitch task
    Battery of listening tests for non-verbal auditory cognition assessment: - Short term memory for pitch task: percentage of correct responses
    Non-verbal auditory testing: Emotional prosody recognition task
    Battery of listening tests for non-verbal auditory cognition assessment: - Emotional prosody recognition task: perception of correct responses
    Non-verbal auditory testing: Auditory Streaming separation task
    Battery of listening tests for non-verbal auditory cognition assessment: - Auditory Streaming separation task : mean frequency (in Hz) of perception change between 1 and 2 streams
    Non-verbal auditory testing: Pitch Change Detection task
    Battery of listening tests for non-verbal auditory cognition assessment: - Pitch Change Detection task: percentage of correct responses
    Non-verbal auditory testing: Direction of pitch change identification task
    Battery of listening tests for non-verbal auditory cognition assessment: - Direction of pitch change identification task: percentage of correct responses
    Non-verbal auditory testing: Short term memory for pitch task
    Battery of listening tests for non-verbal auditory cognition assessment: - Short term memory for pitch task: percentage of correct responses
    Non-verbal auditory testing: Emotional prosody recognition task
    Battery of listening tests for non-verbal auditory cognition assessment: - Emotional prosody recognition task: perception of correct responses
    Non-verbal auditory testing: Auditory Streaming separation task
    Battery of listening tests for non-verbal auditory cognition assessment: - Auditory Streaming separation task : mean frequency (in Hz) of perception change between 1 and 2 streams
    Non-verbal auditory testing: Pitch Change Detection task
    Battery of listening tests for non-verbal auditory cognition assessment: - Pitch Change Detection task: percentage of correct responses
    Non-verbal auditory testing: Direction of pitch change identification task
    Battery of listening tests for non-verbal auditory cognition assessment: - Direction of pitch change identification task: percentage of correct responses
    Non-verbal auditory testing: Short term memory for pitch task
    Battery of listening tests for non-verbal auditory cognition assessment: - Short term memory for pitch task: percentage of correct responses
    Non-verbal auditory testing: Emotional prosody recognition task
    Battery of listening tests for non-verbal auditory cognition assessment: - Emotional prosody recognition task: perception of correct responses
    Non-verbal auditory testing: Auditory Streaming separation task
    Battery of listening tests for non-verbal auditory cognition assessment: - Auditory Streaming separation task : mean frequency (in Hz) of perception change between 1 and 2 streams

    Full Information

    First Posted
    March 22, 2023
    Last Updated
    April 27, 2023
    Sponsor
    Humans Matter
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05848661
    Brief Title
    Evaluation of a Digital Therapy of Auditory Training
    Acronym
    AUDISSEE
    Official Title
    AUDISSEE-Evaluation of a New Digital Therapy of a Cognitive Auditory Training
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    March 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Humans Matter

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of the study is to evaluate the efficiency of the medical device AUDISSEE in improving the perception in noise ability of presbycusis patients with hearing-aids.
    Detailed Description
    AUDISSEE is a digital therapy designed specifically to improve the hearing in noise of presbycusis patients by offering a complete cognitive auditory training, with verbal and non-verbal (especially musical) stimuli. This therapy is designed improve the comfort of life of people fitted with hearing aids by improving the observance of the wearing of their hearing aids. It is designed for the greatest number of people regardless of age or type of hearing aids and adapts to all levels of hearing loss (mild to severe). In this study, 240 patients will be randomized in four groups. The first group will be trained with AUDISSEE-verbal, AUDISSE-non-verbal then with the placebo therapy. The second group will be trained with AUDISSEE-non-verbal, AUDISSEE-verbal, then with the placebo therapy. The third group will be trained with the placebo therapy then AUDISSEE-verbal, and AUDISSE-non-verbal. The fourth group will be trained with the placebo therapy then AUDISSEE-non-verbal, and AUDISSE-verbal. Each training session will last 20 minutes. 3 sessions are planned per week, for 5 weeks for each sub-training. The protocol lasts 20 weeks in total for each patient.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss, Age-Related
    Keywords
    Hearing aid, presbycusis, auditory training, hearing in noise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    In this study, 240 patients will be randomized in four groups. The first group will be trained with AUDISSEE-verbal, AUDISSE-non-verbal then with the placebo therapy. The second group will be trained with AUDISSEE-non-verbal, AUDISSEE-verbal, then with the placebo therapy. The third group will be trained with the placebo therapy then AUDISSEE-verbal, and AUDISSE-non-verbal. The fourth group will be trained with the placebo therapy then AUDISSEE-non-verbal, and AUDISSE-verbal.
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    The training will be performed at home. The investigators/evaluators will send a download link of the therapy to the patients without knowing which therapy it corresponds to.
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AUDISSEE-verbal, AUDISSE-non-verbal, Placebo, Placebo
    Arm Type
    Experimental
    Arm Description
    In this arm, the group will perform first the AUDISSEE therapy starting with the verbal sub-training then the non-verbal sub-training. Then it will perform the placebo training for 10 weeks. The AUDISSEE therapy takes place over 10 weeks with 3 sessions of 20 minutes per week. It is divided into two parts (5 weeks for each part): verbal training exercises in noise that are specifically aimed at improving patients' intelligibility in noise non-verbal training exercises using environmental sounds and musical sounds, which are specifically aimed at improving non-verbal auditory perception
    Arm Title
    AUDISSE-non-verbal, AUDISSEE-verbal, Placebo, Placebo
    Arm Type
    Experimental
    Arm Description
    In this arm, the group will perform first the AUDISSEE therapy starting with the non-verbal sub-training then the verbal sub-training. Then it will perform the placebo training for 10 weeks.
    Arm Title
    Placebo, Placebo, AUDISSEE-verbal, AUDISSE-non-verbal
    Arm Type
    Placebo Comparator
    Arm Description
    In this arm, the group will perform first placebo training for 10 weeks. Then, it will perform the AUDISSEE therapy starting with the verbal sub-training then the non-verbal sub-training. At each session of the placebo therapy, the patient will listen to an excerpt from an audio-book or podcast of similar length to the duration of the training exercises (20 min). This therapy engages the patient in a similar manner than the AUDISSEE therapy in terms of time spent (same session frequency, same session duration), but does not specifically train auditory perception networks.
    Arm Title
    Placebo, Placebo, AUDISSE-non-verbal, AUDISSEE-verbal
    Arm Type
    Placebo Comparator
    Arm Description
    In this arm, the group will perform first placebo training for 10 weeks. Then, it will perform the AUDISSEE therapy starting with the non-verbal sub-training then the verbal sub-training.
    Intervention Type
    Device
    Intervention Name(s)
    AUDISSEE
    Intervention Description
    AUDISSEE is a digital therapy designed specifically to improve the hearing in noise of presbycusis patients by offering a complete cognitive auditory training, with verbal and non-verbal stimuli. The therapy takes place over 10 weeks with 3 sessions of 20 minutes per week.
    Intervention Type
    Device
    Intervention Name(s)
    Placebo
    Intervention Description
    The Placebo is a therapy designed within the same frame as the AUDISSEE therapy but with no auditory exercises, instead the patients are listening to audiobook. The therapy takes place over 10 weeks, with 3 sessions of 20 minutes per week.
    Primary Outcome Measure Information:
    Title
    Hearing in noise
    Description
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
    Time Frame
    5 weeks to baseline
    Title
    Hearing in noise
    Description
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
    Time Frame
    5 weeks to baseline
    Title
    Hearing in noise
    Description
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
    Time Frame
    10 weeks to baseline
    Title
    Hearing in noise
    Description
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
    Time Frame
    10 weeks to baseline
    Title
    Hearing in noise
    Description
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
    Time Frame
    15 weeks to baseline
    Title
    Hearing in noise
    Description
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
    Time Frame
    15 weeks to baseline
    Title
    Hearing in noise
    Description
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
    Time Frame
    20 weeks to baseline
    Title
    Hearing in noise
    Description
    Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
    Time Frame
    20 weeks to baseline
    Secondary Outcome Measure Information:
    Title
    Quality of life and hearing : personal efficacy
    Description
    Questionnaire for the feeling of personal efficacy:14 items with a 5-pt likert scale, a mean score is measured (between 1 and 5)
    Time Frame
    5 weeks to baseline
    Title
    Quality of life and hearing : listening effort
    Description
    Questionnaire for the listening effort: 10 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Time Frame
    5 weeks to baseline
    Title
    Quality of life and hearing : spatial learning abilities
    Description
    Questionnaire for the spatial learning abilities (SSQ15): 15 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Time Frame
    5 weeks to baseline
    Title
    Quality of life and hearing: personal efficacy
    Description
    Questionnaire for the feeling of personal efficacy:14 items with a 5-pt likert scale, a mean score is measured (between 1 and 5)
    Time Frame
    10 weeks to baseline
    Title
    Quality of life and hearing: listening effort
    Description
    Questionnaire for the listening effort: 10 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Time Frame
    10 weeks to baseline
    Title
    Quality of life and hearing: spatial learning abilities
    Description
    Questionnaire for the spatial learning abilities (SSQ15): 15 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Time Frame
    10 weeks to baseline
    Title
    Quality of life and hearing: personal efficacy
    Description
    Questionnaire for the feeling of personal efficacy:14 items with a 5-pt likert scale, a mean score is measured (between 1 and 5)
    Time Frame
    15 weeks to baseline
    Title
    Quality of life and hearing: listening effort
    Description
    Questionnaire for the listening effort: 10 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Time Frame
    15 weeks to baseline
    Title
    Quality of life and hearing: spatial learning abilities
    Description
    Questionnaire for the spatial learning abilities (SSQ15): 15 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Time Frame
    15 weeks to baseline
    Title
    Quality of life and hearing: personal efficacy
    Description
    Questionnaire for the feeling of personal efficacy:14 items with a 5-pt likert scale, a mean score is measured (between 1 and 5)
    Time Frame
    20 weeks to baseline
    Title
    Quality of life and hearing: listening effort
    Description
    Questionnaire for the listening effort: 10 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Time Frame
    20 weeks to baseline
    Title
    Quality of life and hearing: spatial learning abilities
    Description
    Questionnaire for the spatial learning abilities (SSQ15): 15 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
    Time Frame
    20 weeks to baseline
    Title
    Non-verbal auditory testing :pitch change detection task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Pitch Change Detection task: percentage of correct responses
    Time Frame
    5 weeks to baseline
    Title
    Non-verbal auditory testing: Direction of pitch change identification task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Direction of pitch change identification task: percentage of correct responses
    Time Frame
    5 weeks to baseline
    Title
    Non-verbal auditory testing: Short term memory for pitch task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Short term memory for pitch task: percentage of correct responses
    Time Frame
    5 weeks to baseline
    Title
    Non-verbal auditory testing: Emotional prosody recognition task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Emotional prosody recognition task: perception of correct responses
    Time Frame
    5 weeks to baseline
    Title
    Non-verbal auditory testing: Auditory Streaming separation task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Auditory Streaming separation task: mean frequency (in Hz) of perception change between 1 and 2 streams
    Time Frame
    5 weeks to baseline
    Title
    Non-verbal auditory testing: Pitch Change Detection task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Pitch Change Detection task: percentage of correct responses
    Time Frame
    10 weeks to baseline
    Title
    Non-verbal auditory testing: Direction of pitch change identification task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Direction of pitch change identification task: percentage of correct responses
    Time Frame
    10 weeks to baseline
    Title
    Non-verbal auditory testing: Short term memory for pitch task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Short term memory for pitch task: percentage of correct responses
    Time Frame
    10 weeks to baseline
    Title
    Non-verbal auditory testing: Emotional prosody recognition task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Emotional prosody recognition task: perception of correct responses
    Time Frame
    10 weeks to baseline
    Title
    Non-verbal auditory testing: Auditory Streaming separation task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Auditory Streaming separation task : mean frequency (in Hz) of perception change between 1 and 2 streams
    Time Frame
    10 weeks to baseline
    Title
    Non-verbal auditory testing: Pitch Change Detection task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Pitch Change Detection task: percentage of correct responses
    Time Frame
    15 weeks to baseline
    Title
    Non-verbal auditory testing: Direction of pitch change identification task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Direction of pitch change identification task: percentage of correct responses
    Time Frame
    15 weeks to baseline
    Title
    Non-verbal auditory testing: Short term memory for pitch task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Short term memory for pitch task: percentage of correct responses
    Time Frame
    15 weeks to baseline
    Title
    Non-verbal auditory testing: Emotional prosody recognition task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Emotional prosody recognition task: perception of correct responses
    Time Frame
    15 weeks to baseline
    Title
    Non-verbal auditory testing: Auditory Streaming separation task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Auditory Streaming separation task : mean frequency (in Hz) of perception change between 1 and 2 streams
    Time Frame
    15 weeks to baseline
    Title
    Non-verbal auditory testing: Pitch Change Detection task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Pitch Change Detection task: percentage of correct responses
    Time Frame
    20 weeks to baseline
    Title
    Non-verbal auditory testing: Direction of pitch change identification task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Direction of pitch change identification task: percentage of correct responses
    Time Frame
    20 weeks to baseline
    Title
    Non-verbal auditory testing: Short term memory for pitch task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Short term memory for pitch task: percentage of correct responses
    Time Frame
    20 weeks to baseline
    Title
    Non-verbal auditory testing: Emotional prosody recognition task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Emotional prosody recognition task: perception of correct responses
    Time Frame
    20 weeks to baseline
    Title
    Non-verbal auditory testing: Auditory Streaming separation task
    Description
    Battery of listening tests for non-verbal auditory cognition assessment: - Auditory Streaming separation task : mean frequency (in Hz) of perception change between 1 and 2 streams
    Time Frame
    20 weeks to baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age over 18 No neurological or psychiatric background No major cognitive deficit, able to understand and apply the recommendation Motivated to participate Have given its written consent Affiliated to a social security system Diagnostic of presbycusis by a health professional Hearing-aids since less than 2 years (no cochlear implants) No tinnitus With a possible access to a personal computer, tactile tablet or smart-phone to perform the training Exclusion Criteria: Age below 18 Pregnant or breastfeeding women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    agathe pralus, PhD
    Phone
    +33611828004
    Email
    a.pralus@humansmatter.co
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    agathe pralus, PhD
    Organizational Affiliation
    Humans Matter
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluation of a Digital Therapy of Auditory Training

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