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WithdrawnNCT05946395CODITIONUpdated Mar 27, 2025

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

An interventional study of Hearing aid and Speech therapy session in Hearing Loss, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Withdrawn. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Prevention

Why this study was withdrawn
The sponsor, in consultation with the coordinating investigator, decided to stop the study prematurely on 23/10/2024. Unfortunately, no patients were included in the study.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
65 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

Browse Hearing Loss studies →

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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 · Other: Speech therapy session

  • Active comparator
    Hearing aid and deferred speech therapy

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

    Device: Hearing aid · Other: Speech therapy session

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.

06

What researchers measure

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.

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05946395
Lead sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborators
Euraxi Pharma
Responsible party
Sponsor
First posted
Jul 14, 2023
Start date
Apr 2024 (estimated)
Primary completion
Apr 2026 (estimated)
Completion
Apr 2026 (estimated)
Last update
Mar 27, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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