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Sponsored by: |
Hospices Civils de Lyon |
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Information provided by: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT00488007 |
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
Condition | Intervention |
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Alzheimer Disease Presbycusis |
Device: Hearing aids used : PHONAK Savia and Valeo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-Economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis |
Estimated Enrollment: | 30 |
Study Start Date: | May 2007 |
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Xavier PERROT, MD | 0033472666406 | xavier.perrot@chu-lyon.fr |
France | |
Xavier PERROT | Recruiting |
LYON, France, 69495 | |
Contact: Xavier PERROT, MD 0033472666406 xavier.perrot@chu-lyon.fr | |
Principal Investigator: Marc BONNEFOY, MD |
Principal Investigator: | Marc BONNEFOY, MD | Hospices Civils de Lyon |
Study ID Numbers: | 2006.414 |
Study First Received: | June 18, 2007 |
Last Updated: | June 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00488007 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Alzheimer disease Cognitive impairment Sensorineural hearing loss Hearing aids |
Sensation Disorders Otorhinolaryngologic Diseases Sensorineural hearing loss Alzheimer Disease Quality of Life Central Nervous System Diseases Presbycusis Hearing Loss, Sensorineural Brain Diseases Neurodegenerative Diseases Ear Diseases |
Cognition Disorders Signs and Symptoms Hearing Disorders Deafness Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Neurologic Manifestations Hearing Loss Dementia Delirium |
Nervous System Diseases Tauopathies |