Hearing Loss
Conditions
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.
Interventions
DEVICEHearing aid
Fitting a hearing aid
OTHERSpeech 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.
Sponsors
Euraxi Pharma
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed