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

Not Applicable

Withdrawn

• Conditions: Hearing Loss
• Interventions: Device: Hearing aid; Other: Speech therapy session

• Registration Number: NCT05946395
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-14
• Study Start: 2024-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hearing aid and synchronous speech therapy	Speech therapy session	This arm will begin speech therapy at the same time as the fitting of the hearing aid.
Hearing aid and synchronous speech therapy	Hearing aid	This arm will begin speech therapy at the same time as the fitting of the hearing aid.
Hearing aid and deferred speech therapy	Hearing aid	This arm will begin speech therapy 3 months after fitting the device.
Hearing aid and deferred speech therapy	Speech therapy session	This arm will begin speech therapy 3 months after fitting the device.

Primary Outcome Measures

Name	Time	Method
Assessment of the Impact of Deafness in Adults	3 months	Score of the questionnaire "Assessment of the Impact of Deafness in Adults" obtained at 3 months compared to the inclusion score.; The ERSA (Evaluation of the Repercussions of Deafness in Adults) assesses four areas: quality of life, personal life, social life and professional life. It is rated out of 200 or out of 150 in the absence of professional life. The higher the ERSA score, the better the patient's quality of life.