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

NCT ID: NCT07321691

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2028-02-29

Brief Summary

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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

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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

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Deafness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Single Case Experimental Design (SCED) consists in repeated measures in a small sample size. Each subject acts as his own control.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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transmitter with receiver

hearing rehabilitations : a transmitter with several receivers

Group Type EXPERIMENTAL

use of hearing rehabilitation device

Intervention Type OTHER

the use hearing rehabilitation devices aimed to improve audibility

listening assistant.

one type of hearing rehabilitations

Group Type ACTIVE_COMPARATOR

use of hearing rehabilitation device

Intervention Type OTHER

the use hearing rehabilitation devices aimed to improve audibility

No hearing device

no hearing device

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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use of hearing rehabilitation device

the use hearing rehabilitation devices aimed to improve audibility

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Toulouse

Toulouse, , France

Site Status

Countries

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France

Central Contacts

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Professor Mathieu MARX

Role: CONTACT

05-61-77-77-04

Soumia TAOUI

Role: CONTACT

Facility Contacts

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Mathieu MARX, MD

Role: primary

05-61-77-77-04

Soumia TAOUI

Role: backup

Other Identifiers

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2025-A01543-46

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/23/0390

Identifier Type: -

Identifier Source: org_study_id

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