Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids
NCT ID: NCT00488007
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2007-05-31
2013-09-30
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Hearing aids
Active
Hearing aids used : PHONAK Savia and Valeo
5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active)
Inactive Hearing aids
Hearing aids turned off
Hearing aids used : PHONAK Savia and Valeo
5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active)
Interventions
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Hearing aids used : PHONAK Savia and Valeo
5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active)
Eligibility Criteria
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Inclusion Criteria
* 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
* Change in the anticholinesterasic treatment in the last 2 months
65 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Marc BONNEFOY, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Xavier PERROT
Lyon, , France
Countries
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References
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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.
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.
Other Identifiers
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2006.414
Identifier Type: -
Identifier Source: org_study_id