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Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids
This study is currently recruiting participants.
Study NCT00488007   Information provided by Hospices Civils de Lyon
First Received: June 18, 2007   No Changes Posted

June 18, 2007
June 18, 2007
May 2007
 
Cognitive benefit evaluated thanks to the ADAS-Cog scale [ Time Frame: Times of measurements: 0, 6th and 12th month ]
Same as current
No Changes Posted
  • 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 ]
Same as current
 
Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids
Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-Economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis

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

 
 
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
  • Alzheimer Disease
  • Presbycusis
Device: Hearing aids used : PHONAK Savia and Valeo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
30
 
 

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
Both
65 Years and older
No
Contact: Xavier PERROT, MD 0033472666406 xavier.perrot@chu-lyon.fr
France
 
NCT00488007
 
2006.414
Hospices Civils de Lyon
 
Principal Investigator: Marc BONNEFOY, MD Hospices Civils de Lyon
Hospices Civils de Lyon
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP