Back to resultsClinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids
Primary Purpose
Alzheimer Disease, Presbycusis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hearing aids used : PHONAK Savia and Valeo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer disease, Cognitive impairment, Sensorineural hearing loss, Hearing aids
Eligibility Criteria
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
Sites / Locations
- Xavier PERROT
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Hearing aids
Inactive Hearing aids
Arm Description
Active
Hearing aids turned off
Outcomes
Primary Outcome Measures
Cognitive benefit evaluated thanks to the ADAS-Cog scale
Secondary Outcome Measures
Cognitive scales: MMSE, Grober and Buschke, Digit symbol test
Behavioural scales: IADL, NPI
Quality of life scales: Zarit scale and ADRQL
Consumption questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00488007
Brief Title
Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids
Official Title
Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Presbycusis
Keywords
Alzheimer disease, Cognitive impairment, Sensorineural hearing loss, Hearing aids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Hearing aids
Arm Type
Experimental
Arm Description
Active
Arm Title
Inactive Hearing aids
Arm Type
Placebo Comparator
Arm Description
Hearing aids turned off
Intervention Type
Device
Intervention Name(s)
Hearing aids used : PHONAK Savia and Valeo
Intervention Description
5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active)
Primary Outcome Measure Information:
Title
Cognitive benefit evaluated thanks to the ADAS-Cog scale
Time Frame
Times of measurements: 0, 6th and 12th month
Secondary Outcome Measure Information:
Title
Cognitive scales: MMSE, Grober and Buschke, Digit symbol test
Time Frame
0, 6th and 12th month
Title
Behavioural scales: IADL, NPI
Time Frame
1st week, 3rd 6th 9th and 12th month
Title
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)
Title
Consumption questionnaire
Time Frame
monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc BONNEFOY, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xavier PERROT
City
Lyon
ZIP/Postal Code
69495
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
28387664
Citation
Nguyen MF, Bonnefoy M, Adrait A, Gueugnon M, Petitot C, Collet L, Roux A, Perrot X; ADPHA study group. Efficacy of Hearing Aids on the Cognitive Status of Patients with Alzheimer's Disease and Hearing Loss: A Multicenter Controlled Randomized Trial. J Alzheimers Dis. 2017;58(1):123-137. doi: 10.3233/JAD-160793.
Results Reference
derived
PubMed Identifier
28269769
Citation
Adrait A, Perrot X, Nguyen MF, Gueugnon M, Petitot C, Collet L, Roux A, Bonnefoy M; ADPHA study group. Do Hearing Aids Influence Behavioral and Psychological Symptoms of Dementia and Quality of Life in Hearing Impaired Alzheimer's Disease Patients and Their Caregivers? J Alzheimers Dis. 2017;58(1):109-121. doi: 10.3233/JAD-160792.
Results Reference
derived
Learn more about this trial
Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids
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