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

Hearing Loss Clinical Trial

— CODITION  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05946395
• Other study ID #: 2022-A02788-35
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2026

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Arnaud DEVEZE, MD
• Phone: 683870819
• Email: dr.deveze[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communication Disorders
• Hearing Loss

Intervention

Device:
• Hearing aid
Fitting a hearing aid

Other:
• Speech therapy session
As speech therapy is part of standard care, the objective of the study will be to compare the impact of synchronous or delayed audioprosthetic and speech therapy care on the impact of deafness in elderly patients.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the Impact of Deafness in Adults	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.	3 months