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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Hearing aid
* Other: Speech therapy session


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hearing aid and synchronous speech therapy<br>This arm will begin speech therapy at the same time as the fitting of the hearing aid. | Device: Hearing aid<br>* Fitting a hearing aid<br>Other: Speech therapy session<br>* 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.<br>|
| Active Comparator: Hearing aid and deferred speech therapy<br>This arm will begin speech therapy 3 months after fitting the device. | Device: Hearing aid<br>* Fitting a hearing aid<br>Other: Speech therapy session<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |