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
Information provided by:
Hospices Civils de Lyon Identifier:
First received: June 18, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

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
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:

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

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00488007

Contact: Xavier PERROT, MD 0033472666406

Xavier PERROT Recruiting
Lyon, France, 69495
Contact: Xavier PERROT, MD    0033472666406   
Principal Investigator: Marc BONNEFOY, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Marc BONNEFOY, MD Hospices Civils de Lyon
  More Information 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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Hearing Loss, Sensorineural
Hearing Loss
Hearing Disorders
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms processed this record on August 23, 2016