Evaluation of a Digital Therapy of Auditory Training (AUDISSEE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hearing Loss, Age-Related
• Intervention / Treatment: Device: AUDISSEE; Device: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: agathe pralus, PhD; Phone Number: +33611828004; Email: a.pralus@humansmatter.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Humans Matter
• Investigators: Study Chair: agathe pralus, PhD, Humans Matter

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hearing aid; presbycusis; auditory training; hearing in noise
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss, Sensorineural; Hearing Loss; Presbycusis
• Other Study ID Numbers: 2023-A00248-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No