Auditory Rehabilitation and Cognition in Alzheimer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Auditory Rehabilitation With Hearing Aids and Cognition in Alzheimer Patients

Conditions
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Alzheimer's Disease, Hearing Loss

Intervention / Treatment
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* Device: Hearing aids
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients treated with hearing aids<br>Patients fitted with functional hearing aids (Phonak Audéo BR) | Device: Hearing aids<br>* Phonak Audéo B-R (Target V 5.0)<br>|
| Placebo Comparator: Patients treated with placebo device<br>Patients fitted with non-functional hearing aids | Device: Placebo<br>* Phonak Audéo B-R (Target V 5.0) without amplification<br>* Other names: Non functional hearing aids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer, Hearing loss, Cognition, Quality of life, Hearing aids