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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
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

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

ClinicalTrials.gov Identifier: NCT00488007     History of Changes
Other Study ID Numbers: 2006.414
Study First Received: June 18, 2007
Last Updated: June 18, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Alzheimer disease
Cognitive impairment
Sensorineural hearing loss
Hearing aids

Additional relevant MeSH terms:
Ear Diseases
Alzheimer Disease
Presbycusis
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
 Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Hearing Loss, Sensorineural
Hearing Loss
Hearing Disorders
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013