Hearing LossCODITIONNCT05946395
Comparison of Speech Therapy and Audioprosthetic Care in Older Adults With First-time Hearing Aids
A study testing Hearing aid and Speech therapy session in people with Hearing Loss, run by GCS Ramsay Santé pour l'Enseignement et la Recherche.
Trial 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 more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing aid and Speech therapy session
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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.
About this study
Official title: Comparison of Synchronous or Delayed Speech Therapy and Audioprosthetic Care in Older Adults With First-time Hearing Aids
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.
- Conditions
- Hearing Loss
- Being tested
- Hearing aid, Speech therapy session
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aidDevice
Fitting a hearing aid
Speech therapy sessionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hearing aid and synchronous speech therapy | Experimental | This arm will begin speech therapy at the same time as the fitting of the hearing aid. Receives: Device: Hearing aid; Other: Speech therapy session |
| Hearing aid and deferred speech therapy | Active comparator | This arm will begin speech therapy 3 months after fitting the device. Receives: Device: Hearing aid; Other: Speech therapy session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study startApr 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946395
- Sponsor's protocol ID
- 2022-A02788-35
- Acronym
- CODITION
- Status last verified
- Mar 2025
- First submitted
- 27 Jun 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Synchronous or Delayed Speech Therapy and Audioprosthetic Care in Older Adults With First-time Hearing Aids
- ClinicalTrials.gov ID
- NCT05946395
- Acronym / sponsor ID
- CODITION / 2022-A02788-35
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hearing aid and synchronous speech therapy | Experimental | Device: Hearing aid, Other: Speech therapy sessionThis arm will begin speech therapy at the same time as the fitting of the hearing aid. |
| Hearing aid and deferred speech therapy | Active comparator | Device: Hearing aid, Other: Speech therapy sessionThis arm will begin speech therapy 3 months after fitting the device. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing aidFitting a hearing aid | Device | Hearing aid and deferred speech therapy, Hearing aid and synchronous speech therapy |
| Speech therapy sessionAs 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. | Other | Hearing aid and deferred speech therapy, Hearing aid and synchronous speech therapy |
Primary outcome
Assessment of the Impact of Deafness in Adults
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing aid and Speech therapy session in people with Hearing Loss, run by GCS Ramsay Santé pour l'Enseignement et la Recherche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the Impact of Deafness in Adults (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.