Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids
NCT00488007 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2025-12-19
Summary
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
Conditions
- Alzheimer Disease
- Presbycusis
Interventions
- DEVICE
-
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)
Sponsors & Collaborators
-
Hospices Civils de Lyon
lead OTHER
Principal Investigators
-
Marc BONNEFOY, MD · Hospices Civils de Lyon
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-05-31
- Primary Completion
- 2013-06-30
- Completion
- 2013-09-30
Countries
- France
Study Locations
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