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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with hearing aids | Experimental | Patients fitted with functional hearing aids (Phonak Audéo BR) |
|
| Patients treated with placebo device | Placebo Comparator | Patients fitted with non-functional hearing aids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing aids | Device | Phonak Audéo B-R (Target V 5.0) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale | French scale validated by the french society of geriatry | Change before and one year after the fitting with device |
| Measure | Description | Time Frame |
|---|---|---|
| air and bone auditory thresholds (dB HL) measured at 500, 1000, 2000, 3000 and 4000 Hz | Tonal audiometry | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DAVID BAKHOS, MCU-PU | University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Tours | 37044 | France |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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| Placebo |
| Device |
Phonak Audéo B-R (Target V 5.0) without amplification |
|
|
Speech audiometry |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |