Clinical trial NCT05848661: Evaluation of a Digital Therapy of Auditory Training
Official title: AUDISSEE-Evaluation of a New Digital Therapy of a Cognitive Auditory Training
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hearing Loss, Age-Related
Keywords: Hearing aid
presbycusis
auditory training
hearing in noise
Lead sponsor: Humans Matter
Sponsor class: INDUSTRY
First posted: 2023-05-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hearing in noise
timeFrame: 5 weeks to baseline
measure: Hearing in noise
timeFrame: 5 weeks to baseline
measure: Hearing in noise
timeFrame: 10 weeks to baseline
measure: Hearing in noise
timeFrame: 10 weeks to baseline
measure: Hearing in noise
timeFrame: 15 weeks to baseline
measure: Hearing in noise
timeFrame: 15 weeks to baseline
measure: Hearing in noise
timeFrame: 20 weeks to baseline
measure: Hearing in noise
timeFrame: 20 weeks to baseline
Secondary outcomes:
measure: Quality of life and hearing : personal efficacy
timeFrame: 5 weeks to baseline
measure: Quality of life and hearing : listening effort
timeFrame: 5 weeks to baseline
measure: Quality of life and hearing : spatial learning abilities
timeFrame: 5 weeks to baseline
measure: Quality of life and hearing: personal efficacy
timeFrame: 10 weeks to baseline
measure: Quality of life and hearing: listening effort
timeFrame: 10 weeks to baseline
measure: Quality of life and hearing: spatial learning abilities
timeFrame: 10 weeks to baseline
measure: Quality of life and hearing: personal efficacy
timeFrame: 15 weeks to baseline
measure: Quality of life and hearing: listening effort
timeFrame: 15 weeks to baseline
measure: Quality of life and hearing: spatial learning abilities
timeFrame: 15 weeks to baseline
measure: Quality of life and hearing: personal efficacy
timeFrame: 20 weeks to baseline
measure: Quality of life and hearing: listening effort
timeFrame: 20 weeks to baseline
measure: Quality of life and hearing: spatial learning abilities
timeFrame: 20 weeks to baseline
measure: Non-verbal auditory testing :pitch change detection task
timeFrame: 5 weeks to baseline
measure: Non-verbal auditory testing: Direction of pitch change identification task
timeFrame: 5 weeks to baseline
measure: Non-verbal auditory testing: Short term memory for pitch task
timeFrame: 5 weeks to baseline
measure: Non-verbal auditory testing: Emotional prosody recognition task
timeFrame: 5 weeks to baseline
measure: Non-verbal auditory testing: Auditory Streaming separation task
timeFrame: 5 weeks to baseline
measure: Non-verbal auditory testing: Pitch Change Detection task
timeFrame: 10 weeks to baseline
measure: Non-verbal auditory testing: Direction of pitch change identification task
timeFrame: 10 weeks to baseline
measure: Non-verbal auditory testing: Short term memory for pitch task
timeFrame: 10 weeks to baseline
measure: Non-verbal auditory testing: Emotional prosody recognition task
timeFrame: 10 weeks to baseline
measure: Non-verbal auditory testing: Auditory Streaming separation task
timeFrame: 10 weeks to baseline
measure: Non-verbal auditory testing: Pitch Change Detection task
timeFrame: 15 weeks to baseline
measure: Non-verbal auditory testing: Direction of pitch change identification task
timeFrame: 15 weeks to baseline
measure: Non-verbal auditory testing: Short term memory for pitch task
timeFrame: 15 weeks to baseline
measure: Non-verbal auditory testing: Emotional prosody recognition task
timeFrame: 15 weeks to baseline
measure: Non-verbal auditory testing: Auditory Streaming separation task
timeFrame: 15 weeks to baseline
measure: Non-verbal auditory testing: Pitch Change Detection task
timeFrame: 20 weeks to baseline
measure: Non-verbal auditory testing: Direction of pitch change identification task
timeFrame: 20 weeks to baseline
measure: Non-verbal auditory testing: Short term memory for pitch task
timeFrame: 20 weeks to baseline
measure: Non-verbal auditory testing: Emotional prosody recognition task
timeFrame: 20 weeks to baseline
measure: Non-verbal auditory testing: Auditory Streaming separation task
timeFrame: 20 weeks to baseline
Other outcomes:
Locations:
Study officials:
affiliation: Humans Matter
name: agathe pralus, PhD
role: STUDY_CHAIR
References: