Evaluation of a Digital Therapy of Auditory Training

Study Overview
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Brief Summary
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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
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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.

Official Title
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AUDISSEE-Evaluation of a New Digital Therapy of a Cognitive Auditory Training

Conditions
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Hearing Loss, Age-Related

Intervention / Treatment
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* Device: AUDISSEE
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AUDISSEE-verbal, AUDISSE-non-verbal, Placebo, Placebo<br>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 | Device: AUDISSEE<br>* 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.<br>Device: Placebo<br>* 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.<br>|
| Experimental: AUDISSE-non-verbal, AUDISSEE-verbal, Placebo, Placebo<br>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. | Device: AUDISSEE<br>* 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.<br>Device: Placebo<br>* 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.<br>|
| Placebo Comparator: Placebo, Placebo, AUDISSEE-verbal, AUDISSE-non-verbal<br>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. | Device: AUDISSEE<br>* 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.<br>Device: Placebo<br>* 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.<br>|
| Placebo Comparator: Placebo, Placebo, AUDISSE-non-verbal, AUDISSEE-verbal<br>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. | Device: AUDISSEE<br>* 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.<br>Device: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 15 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 | 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 | 20 weeks to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 20 weeks to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing aid, presbycusis, auditory training, hearing in noise