Comparison of Speech Therapy and Audioprosthetic Care in Older Adults With First-time Hearing Aids (CODITION)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Withdrawn

Conditions: Hearing Loss

Treatments: Device: Hearing aid; Other: Speech therapy session

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05946395

2022-A02788-35

Details and patient eligibility

About

The purpose of the study is to evaluate the score of the Evaluation of the Impact of Deafness in Adults(ERSA)/150 questionnaire obtained at 3 months compared to the inclusion score.

Full description

This is a pilot, prospective, interventional, comparative, randomized, longitudinal, open, multicenter study comparing synchronous and delayed hearing aid and speech therapy.

Patients will be randomly divided by drawing lots into 2 groups. Both groups will benefit from a hearing aid prescription and speech therapy for a series of 24 sessions at the rate of 1 per week, for an approximate duration of 6 months. Group A will benefit from speech therapy and synchronous equipment, and group B will begin speech therapy after 3 months after the installation of the equipment.

Regarding the equipment, it will not be the same for all patients. Indeed, it is the one that will best suit the patient who will be chosen. The same will apply to the settings, in accordance with the usual support.

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient, male or female, aged 65 to 80;
• First equipment;
• Average hearing loss between 40 and 70 db;
• Speech comprehension greater than 50%;
• Absence of acoustic recruitment phenomenon;
• Symmetrical bilateral deafness (inter aural difference <20dB);
• Affiliated patient or beneficiary of a social security scheme;
• Patient speaking and understanding French, able to complete questionnaires and scales;
• Patient having been informed and having signed an informed consent to participate in the study.

Exclusion criteria

• Patient with a psychiatric pathology;
• Patient with neurological disorders;
• Patient taking psychotropic drugs;
• Patient participating in another clinical study;
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
• Patient hospitalized without consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Hearing aid and synchronous speech therapy

Experimental group

Description:

This arm will begin speech therapy at the same time as the fitting of the hearing aid.

Treatment:

Other: Speech therapy session

Device: Hearing aid

Hearing aid and deferred speech therapy

Active Comparator group

Description:

This arm will begin speech therapy 3 months after fitting the device.

Treatment:

Other: Speech therapy session

Device: Hearing aid