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

Sponsor:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00488007

Purpose

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

Condition	Intervention
Alzheimer Disease Presbycusis	Device: Hearing aids used : PHONAK Savia and Valeo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-Economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease nonsyndromic deafness

MedlinePlus related topics: Alzheimer's Disease Hearing Aids Hearing Disorders and Deafness

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	30
Study Start Date:	May 2007

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488007

Contacts

Contact: Xavier PERROT, MD

0033472666406

xavier.perrot@chu-lyon.fr

Locations

France
Xavier PERROT	Recruiting
LYON, France, 69495
Contact: Xavier PERROT, MD 0033472666406 xavier.perrot@chu-lyon.fr
Principal Investigator: Marc BONNEFOY, MD

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Marc BONNEFOY, MD

Hospices Civils de Lyon

More Information

No publications provided

Study ID Numbers:	2006.414
Study First Received:	June 18, 2007
Last Updated:	June 18, 2007
ClinicalTrials.gov Identifier:	NCT00488007 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Alzheimer disease
Cognitive impairment
Sensorineural hearing loss
Hearing aids

Additional relevant MeSH terms:

Sensation Disorders
Otorhinolaryngologic Diseases
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Presbycusis
Hearing Loss, Sensorineural
Brain Diseases
Neurodegenerative Diseases

Ear Diseases
Signs and Symptoms
Hearing Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Dementia
Tauopathies
Hearing Loss

ClinicalTrials.gov processed this record on November 09, 2009