DeafnessHEAR2SHARENCT07321691
Evaluation of the Effectiveness of a Rehabilitation Program for Hearing and Communication Disorders in Elderly People in Nursing Homes.
A study testing use of hearing rehabilitation device in people with Deafness, run by University Hospital, Toulouse at 1 site in France.
Trial summary
In France, 64% of residents in nursing homes have moderate to severe hearing loss and only 12% are treated with hearing aids. Yet the extra-auditory consequences of presbycusis are numerous: general fatigue, isolation, anxiety and depression. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Deafness
- What is being tested?
- use of hearing rehabilitation device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- residents in nursing homes with hearing impairment (HHIE-S (Hearing Handicap Inventory for the Elderly Screening and pure tone audiometry)
- with an MMS (Mini Mental State) score> 15
- with a GIR Group ≥ à 3 affiliated to a social security scheme
- French speaking
Who cannot join
- wearing any type of hearing aid at the time of inclusion
- having followed a similar training program
- Subjects under juridical protections or tutelage measure
- unable to answer questions and participate in group activities
- with associated life-threatening pathologies and/or a life expectancy in EHPAD of less than 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Soumia TAOUI contact
France1 site
University Hospital Toulouse
Toulouse, 31059
Mathieu MARX, MD, 05-61-77-77-04, marx.m@chu-toulouse.fr
Soumia TAOUI, taoui.s@chu-toulouse.fr
About this study
Official title: Evaluation of the Effectiveness of a Rehabilitation Program for Hearing and Communication Disorders in Elderly People in Nursing Homes: a Single Case Experimental Design (N of 1 Trials Study)
In France, 64% of residents in nursing homes have moderate to severe hearing loss and only 12% are treated with hearing aids. Yet the extra-auditory consequences of presbycusis are numerous: general fatigue, isolation, anxiety and depression. France counted 620 000 nursing home beds in 2020 and this number increases each year by an average of 2% (DREES (Department of Research, Studies, Evaluation and Statistics), France, 2019). Only few studies have focused on hearing disorders in this population, given the importance of their communication difficulties (Solheim J et al., 2016, Kimball A et al., 2017 ). The population in nursing homes is for 80% over 80 years old (DREES (Department of Research, Studies, Evaluation and Statistics) survey, France, 2014). This same survey looked at the proportion of people with functional hearing limitations and their severity depending on where they live. The highest rates were found among people living in institutions (regardless of the degree of functional hearing limitations), with 42% of people living in nursing homes and senior residences who have hearing functional limitations against 15.9 % of those living at home The present study is interested in the management of hearing and communication disorders in nursing homes residents by setting up a program for the rehabilitation of these disorders, based on the use of a simple hearing device by the nursing home staff.
Read the detailed description
The main objective of this study is to assess the effectiveness of a rehabilitation program for hearing and communication disorders intended to improve the communication of residents in nursing homes.
This program includes for the resident:
- the alternative use of two hearing rehabilitation devices aimed to improve audibility
- An inaugural training led by a trained professional to promote oral communication The effectiveness of the two devices will be compared.
This program includes for the staff members:
- A one-day training comprising three components (general concepts concerning deafness and its rehabilitation, training in the use of the device to improve audibility, training in facilitating the communication workshop).
- Conditions
- Deafness
- Being tested
- use of hearing rehabilitation device
- Keywords
- deafness, rehabilitation, nursing homes, elderly subject
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of hearing rehabilitation deviceOther
the use hearing rehabilitation devices aimed to improve audibility
| Study group | Role | What they receive |
|---|---|---|
| transmitter with receiver | Experimental | hearing rehabilitations : a transmitter with several receivers Receives: Other: use of hearing rehabilitation device |
| listening assistant. | Active comparator | one type of hearing rehabilitations Receives: Other: use of hearing rehabilitation device |
| No hearing device | No intervention | no hearing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of the Hear2Share program
The primary outcome will be the effectiveness of the Hear2Share program evaluated by the Percentage of words correctly identified at 60 dB HL measured every weeks
Measured: every weeks from enrollment until end of participation at 15 weeks
Secondary outcomes (1)
wearing time of the device
wearing time of the device in hours and every weeks
Measured: From enrollment to the end of participation at 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Single Case Experimental Design (SCED) consists in repeated measures in a small sample size. Each subject acts as his own control.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321691
- Sponsor's protocol ID
- RC31/23/0390
- Other IDs
- 2025-A01543-46
- Acronym
- HEAR2SHARE
- Status last verified
- May 2026
- First submitted
- 22 Dec 2025
- Last updated
- 19 May 2026
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Rehabilitation Program for Hearing and Communication Disorders in Elderly People in Nursing Homes: a Single Case Experimental Design (N of 1 Trials Study)
- ClinicalTrials.gov ID
- NCT07321691
- Acronym / sponsor ID
- HEAR2SHARE / RC31/23/0390
- Conditions
- Deafness
- Keywords
- deafness, rehabilitation, nursing homes, elderly subject
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 7 Jan 2026 (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.
In France, 64% of residents in nursing homes have moderate to severe hearing loss and only 12% are treated with hearing aids. Yet the extra-auditory consequences of presbycusis are numerous: general fatigue, isolation, anxiety and depression. France counted 620 000 nursing home beds in 2020 and this number increases each year by an average of 2% (DREES (Department of Research, Studies, Evaluation and Statistics), France, 2019). Only few studies have focused on hearing disorders in this population, given the importance of their communication difficulties (Solheim J et al., 2016, Kimball A et al., 2017 ). The population in nursing homes is for 80% over 80 years old (DREES (Department of Research, Studies, Evaluation and Statistics) survey, France, 2014). This same survey looked at the proportion of people with functional hearing limitations and their severity depending on where they live. The highest rates were found among people living in institutions (regardless of the degree of functional hearing limitations), with 42% of people living in nursing homes and senior residences who have hearing functional limitations against 15.9 % of those living at home The present study is interested in the management of hearing and communication disorders in nursing homes residents by setting up a program for the rehabilitation of these disorders, based on the use of a simple hearing device by the nursing home staff.
Detailed description
The main objective of this study is to assess the effectiveness of a rehabilitation program for hearing and communication disorders intended to improve the communication of residents in nursing homes.
This program includes for the resident:
- the alternative use of two hearing rehabilitation devices aimed to improve audibility
- An inaugural training led by a trained professional to promote oral communication The effectiveness of the two devices will be compared.
This program includes for the staff members:
- A one-day training comprising three components (general concepts concerning deafness and its rehabilitation, training in the use of the device to improve audibility, training in facilitating the communication workshop).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single Case Experimental Design (SCED) consists in repeated measures in a small sample size. Each subject acts as his own control.
| Arm | Type | Receives |
|---|---|---|
| transmitter with receiver | Experimental | Other: use of hearing rehabilitation devicehearing rehabilitations : a transmitter with several receivers |
| listening assistant. | Active comparator | Other: use of hearing rehabilitation deviceone type of hearing rehabilitations |
| No hearing device | No intervention | –no hearing device |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- residents in nursing homes with hearing impairment (HHIE-S (Hearing Handicap Inventory for the Elderly Screening and pure tone audiometry)
- with an MMS (Mini Mental State) score> 15
- with a GIR Group ≥ à 3 affiliated to a social security scheme
- French speaking
Key exclusion criteria (5 listed)
- wearing any type of hearing aid at the time of inclusion
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 |
|---|---|---|
| use of hearing rehabilitation devicethe use hearing rehabilitation devices aimed to improve audibility | Other | listening assistant., transmitter with receiver |
Primary outcome
effectiveness of the Hear2Share program
Time frame: every weeks from enrollment until end of participation at 15 weeks
The primary outcome will be the effectiveness of the Hear2Share program evaluated by the Percentage of words correctly identified at 60 dB HL measured every weeks
1 secondary outcome
wearing time of the device
Time frame: From enrollment to the end of participation at 15 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- 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.
Soumia TAOUI contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of hearing rehabilitation device in people with Deafness, run by University Hospital, Toulouse at 1 site in France.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Mathieu MARX (05-61-77-77-04, marx.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of the Hear2Share program (time frame: every weeks from enrollment until end of participation at 15 weeks). 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 19 May 2026.