Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

Study Overview
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Brief Summary
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This is a 12-months' randomized clinical trial that aims at studying the benefit of bilateral hearing aids in hearing impaired patients suffering from a slight to moderate stage Alzheimer disease. The benefit of this intervention will be studied in the cognitive, behavioural, quality of life and economic fields. 2groups are involved in this trial: Intervention group: 12 months' treatment with active hearing aids, fitted hearing impairment Control group: 6 months' treatment with placebo hearing aids, followed with 6 months' active hearing aids, fitted hearing impairment

Official Title
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Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis

Conditions
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Alzheimer Disease, Presbycusis

Intervention / Treatment
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* Device: Hearing aids used : PHONAK Savia and Valeo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 65 year-old Medical diagnosis of Alzheimer disease 15 ≤ MMSE ≤ 25 No hearing aids in the last 2 years Motivated caregiver living with the patient Sensorineural hearing loss Exclusion Criteria: Beginning of an anticholinesterasic treatment in the last 6 months Change in the anticholinesterasic treatment in the last 2 months

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: Active Hearing aids<br>Active | Device: Hearing aids used : PHONAK Savia and Valeo<br>* 5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active)<br>|
| Placebo Comparator: Inactive Hearing aids<br>Hearing aids turned off | Device: Hearing aids used : PHONAK Savia and Valeo<br>* 5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive benefit evaluated thanks to the ADAS-Cog scale |  | Times of measurements: 0, 6th and 12th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive scales: MMSE, Grober and Buschke, Digit symbol test |  | 0, 6th and 12th month | 
| Behavioural scales: IADL, NPI |  | 1st week, 3rd 6th 9th and 12th month | 
| Quality of life scales: Zarit scale and ADRQL |  | Zarit scale(every 2 months during the study time), ADRQL (0, 6th and 12th month) | 
| Consumption questionnaire |  | monthly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer disease, Cognitive impairment, Sensorineural hearing loss, Hearing aids