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Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

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ClinicalTrials.gov Identifier: NCT00488007
Recruitment Status : Completed
First Posted : June 19, 2007
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):

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


Condition or disease Intervention/treatment
Alzheimer Disease Presbycusis Device: Hearing aids used : PHONAK Savia and Valeo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : May 2007
Primary Completion Date : June 2013
Study Completion Date : September 2013


Arms and Interventions

Arm Intervention/treatment
Experimental: Active Hearing aids
Active
Device: Hearing aids used : PHONAK Savia and Valeo
5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active)
Placebo Comparator: Inactive Hearing aids
Hearing aids turned off
Device: Hearing aids used : PHONAK Savia and Valeo
5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active)


Outcome Measures

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

Secondary Outcome Measures :
  1. Cognitive scales: MMSE, Grober and Buschke, Digit symbol test [ Time Frame: 0, 6th and 12th month ]
  2. Behavioural scales: IADL, NPI [ Time Frame: 1st week, 3rd 6th 9th and 12th month ]
  3. 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) ]
  4. Consumption questionnaire [ Time Frame: monthly ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488007


Locations
France
Xavier PERROT
Lyon, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Marc BONNEFOY, MD Hospices Civils de Lyon
More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00488007     History of Changes
Other Study ID Numbers: 2006.414
First Posted: June 19, 2007    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: December 2011

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

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