Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids - Tabular View

Tracking Information

First Received Date ^ICMJE

June 18, 2007

Last Updated Date

June 18, 2007

Start Date ^ICMJE

May 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Cognitive benefit evaluated thanks to the ADAS-Cog scale [ Time Frame: Times of measurements: 0, 6th and 12th month ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

Official Title ^ICMJE

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 Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Alzheimer Disease
Presbycusis

Intervention ^ICMJE

Device: Hearing aids used : PHONAK Savia and Valeo

Study Arms / Comparison Groups

Publications *

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

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Xavier PERROT, MD

0033472666406

xavier.perrot@chu-lyon.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00488007

Responsible Party

Study ID Numbers ^ICMJE

2006.414

Study Sponsor ^ICMJE

Hospices Civils de Lyon

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Marc BONNEFOY, MD

Hospices Civils de Lyon

Information Provided By

Hospices Civils de Lyon

Verification Date

June 2007

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