Evaluation of a Digital Therapy of Auditory Training

Hearing Loss, Age-Related Clinical Trial

— AUDISSEE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05848661
• Other study ID #: 2023-A00248-37
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Age-Related
• Presbycusis

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