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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
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.
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.
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
Time frame: 5 weeks to baseline
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
Time frame: 5 weeks to baseline
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
Time frame: 10 weeks to baseline
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
Time frame: 10 weeks to baseline
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
Time frame: 15 weeks to baseline
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
Time frame: 15 weeks to baseline
Hearing in noise
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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
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
Time frame: 20 weeks to baseline
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)
Time frame: 5 weeks to baseline
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)
Time frame: 5 weeks to baseline
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)
Time frame: 5 weeks to baseline
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)
Time frame: 10 weeks to baseline
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)
Time frame: 10 weeks to baseline
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)
Time frame: 10 weeks to baseline
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)
Time frame: 15 weeks to baseline
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)
Time frame: 15 weeks to baseline
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)
Time frame: 15 weeks to baseline
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)
Time frame: 20 weeks to baseline
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)
Time frame: 20 weeks to baseline
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)
Time frame: 20 weeks to baseline
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
Time frame: 5 weeks to baseline
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
Time frame: 5 weeks to baseline
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
Time frame: 5 weeks to baseline
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
Time frame: 5 weeks to baseline
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
Time frame: 5 weeks to baseline
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
Time frame: 10 weeks to baseline
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
Time frame: 10 weeks to baseline
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
Time frame: 10 weeks to baseline
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
Time frame: 10 weeks to baseline
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
Time frame: 10 weeks to baseline
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
Time frame: 15 weeks to baseline
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
Time frame: 15 weeks to baseline
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
Time frame: 15 weeks to baseline
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
Time frame: 15 weeks to baseline
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
Time frame: 15 weeks to baseline
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
Time frame: 20 weeks to baseline
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
Time frame: 20 weeks to baseline
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
Time frame: 20 weeks to baseline
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
Time frame: 20 weeks to baseline
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
Time frame: 20 weeks to baseline