Evaluation of the Effectiveness of a Rehabilitation Program for Hearing and Communication Disorders in Elderly People in Nursing Homes. (HEAR2SHARE)

Toulouse University Hospital

Status: Not yet enrolling

Conditions: Deafness

Treatments: Other: use of hearing rehabilitation device

Study type: Interventional

Funder types: Other

Identifiers

NCT07321691

2025-A01543-46 (Other Identifier)

RC31/23/0390

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

40 participants in 3 patient groups

transmitter with receiver

Experimental group

Description:

hearing rehabilitations : a transmitter with several receivers

Treatment:

Other: use of hearing rehabilitation device

listening assistant.

Active Comparator group

Description:

one type of hearing rehabilitations

Treatment:

Other: use of hearing rehabilitation device

No hearing device

No Intervention group

Description:

no hearing device