Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids
Not Applicable
Completed
- Conditions
- PresbycusisAlzheimer Disease
- Registration Number
- NCT00488007
- Lead Sponsor
- Hospices Civils de Lyon
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cognitive benefit evaluated thanks to the ADAS-Cog scale Times of measurements: 0, 6th and 12th month
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Xavier PERROT
🇫🇷Lyon, France