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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05848661
Other study ID # 2023-A00248-37
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date March 2025

Study information

Verified date February 2024
Source Humans Matter
Contact agathe pralus, PhD
Phone +33611828004
Email a.pralus@humansmatter.co
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 240
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AUDISSEE
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.
Placebo
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Humans Matter

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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