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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Hearing aids | Experimental | Active |
|
| Inactive Hearing aids | Placebo Comparator | Hearing aids turned off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing aids used : PHONAK Savia and Valeo | Device | 5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active) |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive benefit evaluated thanks to the ADAS-Cog scale | Times of measurements: 0, 6th and 12th month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc BONNEFOY, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xavier PERROT | Lyon | 69495 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28269769 | Result | Adrait A, Perrot X, Nguyen MF, Gueugnon M, Petitot C, Collet L, Roux A, Bonnefoy M; ADPHA study group. Do Hearing Aids Influence Behavioral and Psychological Symptoms of Dementia and Quality of Life in Hearing Impaired Alzheimer's Disease Patients and Their Caregivers? J Alzheimers Dis. 2017;58(1):109-121. doi: 10.3233/JAD-160792. | |
| 28387664 |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D011304 | Presbycusis |
| D060825 | Cognitive Dysfunction |
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Zarit scale(every 2 months during the study time), ADRQL (0, 6th and 12th month) |
| Consumption questionnaire | monthly |
| Nguyen MF, Bonnefoy M, Adrait A, Gueugnon M, Petitot C, Collet L, Roux A, Perrot X; ADPHA study group. Efficacy of Hearing Aids on the Cognitive Status of Patients with Alzheimer's Disease and Hearing Loss: A Multicenter Controlled Randomized Trial. J Alzheimers Dis. 2017;58(1):123-137. doi: 10.3233/JAD-160793. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D034381 | Hearing Loss |
| 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 |
| D003072 | Cognition Disorders |