Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00488007
First received: June 18, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 18, 2007
June 18, 2007
May 2007
Not Provided
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
Not Provided
Not Provided
 
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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Alzheimer Disease
  • Presbycusis
Device: Hearing aids used : PHONAK Savia and Valeo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
Not Provided

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
No
Not Provided
Hospices Civils de Lyon
Not Provided
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