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Not yet recruiting NCT07321691

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

No phase Interventional Deafness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: use of hearing rehabilitation device.
Who it may be relevant to
Registry conditions: Deafness. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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)

Overview

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).

Interventions

  • Other use of hearing rehabilitation device
    the use hearing rehabilitation devices aimed to improve audibility

Primary outcome measures

  • effectiveness of the Hear2Share program [Time frame: every weeks from enrollment until end of participation at 15 weeks]
Secondary outcome measures (1)
  • wearing time of the device [Time frame: From enrollment to the end of participation at 15 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • University Hospital Toulouse — Toulouse

Identifiers

NCT: NCT07321691 · RC31/23/0390 · 2025-A01543-46

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗