Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00488007
First received: June 18, 2007
Last updated: August 24, 2016
Last verified: December 2011

June 18, 2007
August 24, 2016
May 2007
June 2013   (final data collection date for primary outcome measure)
Cognitive benefit evaluated thanks to the ADAS-Cog scale [ Time Frame: Times of measurements: 0, 6th and 12th month ] [ Designated as safety issue: No ]
Cognitive benefit evaluated thanks to the ADAS-Cog scale [ Time Frame: Times of measurements: 0, 6th and 12th month ]
Complete list of historical versions of study NCT00488007 on ClinicalTrials.gov Archive Site
  • Cognitive scales: MMSE, Grober and Buschke, Digit symbol test [ Time Frame: 0, 6th and 12th month ] [ Designated as safety issue: No ]
  • Behavioural scales: IADL, NPI [ Time Frame: 1st week, 3rd 6th 9th and 12th month ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Consumption questionnaire [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
  • 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 ]
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 (Subject, Investigator)
Primary Purpose: Treatment
  • Alzheimer Disease
  • Presbycusis
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)
  • Experimental: Active Hearing aids
    Active
    Intervention: Device: Hearing aids used : PHONAK Savia and Valeo
  • Placebo Comparator: Inactive Hearing aids
    Hearing aids turned off
    Intervention: Device: Hearing aids used : PHONAK Savia and Valeo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2013
June 2013   (final data collection date for primary outcome measure)

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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00488007
2006.414
No
Not Provided
Not Provided
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Principal Investigator: Marc BONNEFOY, MD Hospices Civils de Lyon
Hospices Civils de Lyon
December 2011

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