AUDISSEE: Evaluation of a Digital Therapy of Auditory Training

Sponsor

Humans Matter (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05848661

Collaborator

(none)

240

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Age-Related	Device: AUDISSEE Device: Placebo	N/A

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).

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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 (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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AUDISSEE-verbal, AUDISSE-non-verbal, Placebo, Placebo 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 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. Device: 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.
Experimental: AUDISSE-non-verbal, AUDISSEE-verbal, Placebo, Placebo 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 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. Device: 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.
Placebo Comparator: Placebo, Placebo, AUDISSEE-verbal, AUDISSE-non-verbal 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 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. Device: 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.
Placebo Comparator: Placebo, Placebo, AUDISSE-non-verbal, AUDISSEE-verbal 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 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. Device: 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.

Outcome Measures

Primary Outcome Measures

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
Hearing in noise [5 weeks to baseline]
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
Hearing in noise [10 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
Hearing in noise [10 weeks to baseline]
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
Hearing in noise [15 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
Hearing in noise [15 weeks to baseline]
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
Hearing in noise [20 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
Hearing in noise [20 weeks to baseline]
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

Secondary Outcome Measures

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)
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 [15 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 [15 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 [15 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 [20 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 [20 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 [20 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)
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
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: Direction of pitch change identification task [10 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 [10 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 [10 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 [10 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 [15 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: Direction of pitch change identification task [15 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 [15 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 [15 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 [15 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 [20 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: Direction of pitch change identification task [20 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 [20 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 [20 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 [20 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Humans Matter

Investigators

Study Chair: agathe pralus, PhD, Humans Matter

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Humans Matter

ClinicalTrials.gov Identifier:

NCT05848661

Other Study ID Numbers:

2023-A00248-37

First Posted:

May 8, 2023

Last Update Posted:

May 8, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Humans Matter

Additional relevant MeSH terms:

Hearing Loss

Presbycusis

Study Results

No Results Posted as of May 8, 2023