Auditory Rehabilitation and Cognition in Alzheimer Patients (RACO-MA)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Alzheimer's Disease; Hearing Loss

Treatments: Device: Hearing aids; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03002142

PHRI15-DB/RACO-MA

Details and patient eligibility

About

Alzheimer disease is a neurodegenerative disease. Recent studies suggest that subjects with hearing loss are more likely to develop Alzheimer's disease. Hearing loss can be consecutive to presbycusis and/or to central auditory dysfunction.

Standard audiometric measures with pure tone and speech intelligibility allow the diagnosis of presbycusis. However, to demonstrate central auditory dysfunction, specific audiometric tests as noisy and/or dichotic tests, are needed.

Actually, no consensus exists to investigate hearing loss in people with Alzheimer's disease; therefore hearing loss may be an early manifestation of Alzheimer's disease. Until now, investigations and clinical procedure related to the diagnosis of Alzheimer's disease ignored the hearing ability of the patient. However, the major part of care management and investigations implies the patient's communication ability with caregivers. Hearing loss may be one of the most unrecognized deficit in subjects with Alzheimer's disease. Auditory rehabilitation with hearing aids could benefit to the patient to decrease cognitive decline but this management must be investigate during longitudinal studies in order to demonstrate their efficiency and need to be compared with a placebo.

Enrollment: 9 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Alzheimer patient
• Mini Mental state examination= 15-25 or mild cognitive impairment
• Over 65 yo
• Sensorineural hearing loss with pure tone average over 30 dB
• Language: French
• Able to sign the consent
• Affiliated to the French social security

Exclusion criteria

• Conductive hearing loss
• Retrocochlear hearing loss
• History of neurological disorders with consequences in hearing loss (vascular accident; brain surgery, cerebral tumors, head trauma with loss consciousness)
• patient included in another study
• French no spoken
• chronic used of drugs or alcohol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

9 participants in 2 patient groups, including a placebo group

Patients treated with hearing aids

Experimental group

Description:

Patients fitted with functional hearing aids (Phonak Audéo BR)

Treatment:

Device: Hearing aids

Patients treated with placebo device

Placebo Comparator group

Description:

Patients fitted with non-functional hearing aids

Treatment:

Device: Placebo