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

NCT05946395 | Withdrawn

• 1 other identifier: 2022-A02788-35
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hearing aid and synchronous speech therapy

EXPERIMENTAL

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

Device: Hearing aid; Other: Speech therapy session

Hearing aid and deferred speech therapy

ACTIVE COMPARATOR

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

Device: Hearing aid; Other: Speech therapy session

Interventions

Hearing aid DEVICE

Fitting a hearing aid

Hearing aid and deferred speech therapy; Hearing aid and synchronous speech therapy

Speech therapy session OTHER

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.

Hearing aid and deferred speech therapy; Hearing aid and synchronous speech therapy

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly divided by drawing lots into 2 groups. 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.

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 14, 2023
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share