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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
9
Phonak Audéo B-R (Target V 5.0)
Phonak Audéo B-R (Target V 5.0) without amplification
University Hospital
Tours, France
Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale
French scale validated by the french society of geriatry
Time frame: Change before and one year after the fitting with device
air and bone auditory thresholds (dB HL) measured at 500, 1000, 2000, 3000 and 4000 Hz
Tonal audiometry
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Speech recognition threshold (dB HL) measured by speech audiometry
Speech audiometry
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Speech Discrimination Test (%) measured by speech audiometry
Speech audiometry
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Dichotic test measured with audiometry
Speech audiometry
Time frame: From 1 to 90 days prior the fitting with device
Amplification with hearing aids or placebo devices measured by tonal and speech audiometry (dB HL)
Audiometry
Time frame: 6 months after the fitting with device, 12 months after the fitting with device
Devices tolerance measured with number of hours per day with hearing aids
Audiometry
Time frame: 6 months after the fitting with device, 12 months after the fitting with device
Objective auditory thresholds measured with auditory brainstem responses (ms)
in case of uncooperative patients or to confirm tonal audiometry
Time frame: 6 months after the fitting with device, 12 months after the fitting with device
Objective auditory thresholds measured by Auditory steady state responses (in dB eHL)
in case of uncooperative patients or to confirm tonal audiometry
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Mini Mental State Examination (30 items, total score from 0-30)
French validated version
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Hearing Handicap Inventory for Elderly measured by questionnaire (10 items, total score from 0-40)
French validated version
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Hearing loss impact scale in adults measured by 2 questionnaire (Abbreviated Profile of Hearing Aid Benefit, 24 items) and Impact of hearing loss in adults (20 items, total score from 0-200)
French validated version
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Quality of life-Alzheimer disease scale measured by questionnaire (total score from 13-52)
French validated version
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Assessing caregiver burden measured by Zarit scale (22 items, total score from 0-88)
French validated version
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Depression in the elderly measured by Geriatric depression scale (30 items, total score from 0-30)
French validated version
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Executive functions measured by trail making test
French validated version
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Working memory and processing speed measured by Wechsler Adult Intelligence Scale
French validated version
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Speech comprehension measured by Beauregard tests
French validated version
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Hearing aids tolerance measured by Glagow hearing-aid benefit questionnaire
French validated version
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
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