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

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05946395
Collaborator
(none)
66
2
33

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hearing aid
  • Other: Speech therapy session
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Prevention
Official Title:
Comparison of Synchronous or Delayed Speech Therapy and Audioprosthetic Care in Older Adults With First-time Hearing Aids
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hearing aid and synchronous speech therapy

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

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.

Active Comparator: Hearing aid and deferred speech therapy

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GCS Ramsay Santé pour l'Enseignement et la Recherche
ClinicalTrials.gov Identifier:
NCT05946395
Other Study ID Numbers:
  • 2022-A02788-35
First Posted:
Jul 14, 2023
Last Update Posted:
Jul 14, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2023