Evaluation of a Digital Therapy of Auditory Training (AUDISSEE)

Humans Matter

Status: Not yet enrolling

Conditions: Hearing Loss, Age-Related

Treatments: Device: Placebo; Device: AUDISSEE

Study type: Interventional

Funder types: Industry

Identifiers

NCT05848661

2023-A00248-37

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

240 participants in 4 patient groups, including a placebo group

AUDISSEE-verbal, AUDISSE-non-verbal, Placebo, Placebo

Experimental group

Description:

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

Treatment:

Device: AUDISSEE

Device: Placebo

AUDISSE-non-verbal, AUDISSEE-verbal, Placebo, Placebo

Experimental group

Description:

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.

Treatment:

Device: AUDISSEE

Device: Placebo

Placebo, Placebo, AUDISSEE-verbal, AUDISSE-non-verbal

Placebo Comparator group

Description:

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.

Treatment:

Device: AUDISSEE

Device: Placebo

Placebo, Placebo, AUDISSE-non-verbal, AUDISSEE-verbal

Placebo Comparator group

Description:

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.

Treatment:

Device: AUDISSEE

Device: Placebo