Hearing Loss, Age-Related
Conditions
Keywords
Hearing aid, presbycusis, auditory training, hearing in noise
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.
Interventions
DEVICEAUDISSEE
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.
DEVICEPlacebo
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.
Sponsors
Humans Matter
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hearing in noise | 5 weeks to baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life and hearing : listening effort | 5 weeks to baseline | 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 | 5 weeks to baseline | 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 | 10 weeks to baseline | 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 | 10 weeks to baseline | 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 | 10 weeks to baseline | 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 | 5 weeks to baseline | Questionnaire for the feeling of personal efficacy:14 items with a 5-pt likert scale, a mean score is measured (between 1 and 5) |
| Non-verbal auditory testing: Direction of pitch change identification task | 5 weeks to baseline | 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 | 5 weeks to baseline | 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 | 5 weeks to baseline | 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 | 5 weeks to baseline | 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 | 10 weeks to baseline | Battery of listening tests for non-verbal auditory cognition assessment: \- Pitch Change Detection task: percentage of correct responses |
| Non-verbal auditory testing :pitch change detection task | 5 weeks to baseline | Battery of listening tests for non-verbal auditory cognition assessment: \- Pitch Change Detection task: percentage of correct responses |
Contacts
Primary Contactagathe pralus, PhD
Outcome results
None listed