Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

August 29, 2016 updated by: Hospices Civils de Lyon

Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69495
        • Xavier PERROT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Cognitive scales: MMSE, Grober and Buschke, Digit symbol test
Time Frame: 0, 6th and 12th month
0, 6th and 12th month
Behavioural scales: IADL, NPI
Time Frame: 1st week, 3rd 6th 9th and 12th month
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)
Zarit scale(every 2 months during the study time), ADRQL (0, 6th and 12th month)
Consumption questionnaire
Time Frame: monthly
monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Marc BONNEFOY, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

June 18, 2007

First Submitted That Met QC Criteria

June 18, 2007

First Posted (ESTIMATE)

June 19, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006.414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Hearing aids used : PHONAK Savia and Valeo

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