Evaluation of a Digital Therapy of Auditory Training

NCT ID: NCT05848661

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-03-31

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.

Conditions

Hearing Loss, Age-Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

AUDISSEE

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

AUDISSEE

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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, 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.

Group Type: PLACEBO_COMPARATOR

AUDISSEE

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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, 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.

Group Type: PLACEBO_COMPARATOR

AUDISSEE

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Humans Matter

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

agathe pralus, PhD

Role: STUDY_CHAIR

Humans Matter

Central Contacts

agathe pralus, PhD

Role: CONTACT

a.pralus@humansmatter.co

+33611828004

Other Identifiers

2023-A00248-37

Identifier Type: -

Identifier Source: org_study_id