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Not yet recruitingNCT07321691HEAR2SHAREUpdated May 19, 2026

Evaluation of the Effectiveness of a Rehabilitation Program for Hearing and Communication Disorders in Elderly People in Nursing Homes.

An interventional study of use of hearing rehabilitation device in Deafness, sponsored by University Hospital, Toulouse. Not yet recruiting at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Deafness

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Keywords

  • deafness
  • rehabilitation
  • nursing homes
  • elderly subject
03

In context

Deafness

160 studies on the registry are indexed under Deafness; 46 are open to participants now.

This study's planned enrollment of 40 is close to the median of 43 across 106 interventional studies indexed under Deafness.

Browse Deafness studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

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

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 in EHPAD of less than 6 months
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    transmitter with receiver

    hearing rehabilitations : a transmitter with several receivers

    Other: use of hearing rehabilitation device

  • Active comparator
    listening assistant.

    one type of hearing rehabilitations

    Other: use of hearing rehabilitation device

  • No intervention
    No hearing device

    no hearing device

Interventions

  • Otheruse of hearing rehabilitation device

    the use hearing rehabilitation devices aimed to improve audibility

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: From enrollment to the end of participation at 15 weeks

07

Study locations

1 site
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 May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07321691
Responsible party
Sponsor
First posted
Jan 7, 2026
Start date
Sep 2026 (estimated)
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
May 19, 2026

Study contacts

Professor Mathieu MARX
Contact
marx.m@chu-toulouse.fr
05-61-77-77-04
Soumia TAOUI
Contact
taoui.s@chu-toulouse.Fr

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 not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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