Back to resultsComparison of Speech Therapy and Audioprosthetic Care in Older Adults With First-time Hearing Aids (CODITION)
Primary Purpose
Hearing Loss
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hearing aid
Speech therapy session
Sponsored by
About this trial
This is an interventional prevention trial for Hearing Loss
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hearing aid and synchronous speech therapy
Hearing aid and deferred speech therapy
Arm Description
This arm will begin speech therapy at the same time as the fitting of the hearing aid.
This arm will begin speech therapy 3 months after fitting the device.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05946395
First Posted
June 27, 2023
Last Updated
July 6, 2023
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT05946395
Brief Title
Comparison of Speech Therapy and Audioprosthetic Care in Older Adults With First-time Hearing Aids
Acronym
CODITION
Official Title
Comparison of Synchronous or Delayed Speech Therapy and Audioprosthetic Care in Older Adults With First-time Hearing Aids
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
April 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hearing aid and synchronous speech therapy
Arm Type
Experimental
Arm Description
This arm will begin speech therapy at the same time as the fitting of the hearing aid.
Arm Title
Hearing aid and deferred speech therapy
Arm Type
Active Comparator
Arm Description
This arm will begin speech therapy 3 months after fitting the device.
Intervention Type
Device
Intervention Name(s)
Hearing aid
Intervention Description
Fitting a hearing aid
Intervention Type
Other
Intervention Name(s)
Speech therapy session
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of the Impact of Deafness in Adults
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud DEVEZE, MD
Phone
683870819
Ext
+33
Email
dr.deveze@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Speech Therapy and Audioprosthetic Care in Older Adults With First-time Hearing Aids
We'll reach out to this number within 24 hrs