Clinical Trial: Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis
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 Summary:
Sponsor: Hospices Civils de Lyon
Current Primary Outcome: Cognitive benefit evaluated thanks to the ADAS-Cog scale [ Time Frame: Times of measurements: 0, 6th and 12th month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Cognitive scales: MMSE, Grober and Buschke, Digit symbol test [ Time Frame: 0, 6th and 12th month ]
- Behavioural scales: IADL, NPI [ Time Frame: 1st week, 3rd 6th 9th and 12th month ]
- Quality of life scales: Zarit scale and ADRQL [ Time Frame: Zarit scale(every 2 months during the study time), ADRQL (0, 6th and 12th month) ]
- Consumption questionnaire [ Time Frame: monthly ]
Original Secondary Outcome: Same as current
Information By: Hospices Civils de Lyon
Dates:
Date Received: June 18, 2007
Date Started: May 2007
Date Completion:
Last Updated: August 29, 2016
Last Verified: December 2011
