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

NCT07321691 | Not Yet Recruiting

• 2 other identifiers: RC31/23/03902025-A01543-46
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Deafness

Keywords

deafness; rehabilitation; nursing homes; elderly subject

Outcome Measures

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

  every weeks from enrollment until end of participation at 15 weeks

Secondary Outcomes (1)

• wearing time of the device

  From enrollment to the end of participation at 15 weeks

Study Arms (3)

transmitter with receiver

EXPERIMENTAL

hearing rehabilitations : a transmitter with several receivers

Other: use of hearing rehabilitation device

listening assistant.

ACTIVE COMPARATOR

one type of hearing rehabilitations

Other: use of hearing rehabilitation device

No hearing device

NO INTERVENTION

no hearing device

Interventions

use of hearing rehabilitation device OTHER

the use hearing rehabilitation devices aimed to improve audibility

listening assistant.; transmitter with receiver

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Professor Mathieu MARX

CONTACT

05-61-77-77-04; marx.m@chu-toulouse.fr

Soumia TAOUI

CONTACT

taoui.s@chu-toulouse.Fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Case Experimental Design (SCED) consists in repeated measures in a small sample size. Each subject acts as his own control.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)