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Auditory Rehabilitation and Cognition in Alzheimer Patients (RACO-MA)

Primary Purpose

Alzheimer's Disease, Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hearing aids
Placebo
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer, Hearing loss, Cognition, Quality of life, Hearing aids

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Alzheimer patient
  • Mini Mental state examination= 15-25 or mild cognitive impairment
  • Over 65 yo
  • Sensorineural hearing loss with pure tone average over 30 dB
  • Language: French
  • Able to sign the consent
  • Affiliated to the French social security

Exclusion Criteria:

  • Conductive hearing loss
  • Retrocochlear hearing loss
  • History of neurological disorders with consequences in hearing loss (vascular accident; brain surgery, cerebral tumors, head trauma with loss consciousness)
  • patient included in another study
  • French no spoken
  • chronic used of drugs or alcohol

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Patients treated with hearing aids

Patients treated with placebo device

Arm Description

Patients fitted with functional hearing aids (Phonak Audéo BR)

Patients fitted with non-functional hearing aids

Outcomes

Primary Outcome Measures

Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale
French scale validated by the french society of geriatry

Secondary Outcome Measures

air and bone auditory thresholds (dB HL) measured at 500, 1000, 2000, 3000 and 4000 Hz
Tonal audiometry
Speech recognition threshold (dB HL) measured by speech audiometry
Speech audiometry
Speech Discrimination Test (%) measured by speech audiometry
Speech audiometry
Dichotic test measured with audiometry
Speech audiometry
Amplification with hearing aids or placebo devices measured by tonal and speech audiometry (dB HL)
Audiometry
Devices tolerance measured with number of hours per day with hearing aids
Audiometry
Objective auditory thresholds measured with auditory brainstem responses (ms)
in case of uncooperative patients or to confirm tonal audiometry
Objective auditory thresholds measured by Auditory steady state responses (in dB eHL)
in case of uncooperative patients or to confirm tonal audiometry
Mini Mental State Examination (30 items, total score from 0-30)
French validated version
Hearing Handicap Inventory for Elderly measured by questionnaire (10 items, total score from 0-40)
French validated version
Hearing loss impact scale in adults measured by 2 questionnaire (Abbreviated Profile of Hearing Aid Benefit, 24 items) and Impact of hearing loss in adults (20 items, total score from 0-200)
French validated version
Quality of life-Alzheimer disease scale measured by questionnaire (total score from 13-52)
French validated version
Assessing caregiver burden measured by Zarit scale (22 items, total score from 0-88)
French validated version
Depression in the elderly measured by Geriatric depression scale (30 items, total score from 0-30)
French validated version
Executive functions measured by trail making test
French validated version
Working memory and processing speed measured by Wechsler Adult Intelligence Scale
French validated version
Speech comprehension measured by Beauregard tests
French validated version
Hearing aids tolerance measured by Glagow hearing-aid benefit questionnaire
French validated version

Full Information

First Posted
March 16, 2016
Last Updated
May 11, 2021
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT03002142
Brief Title
Auditory Rehabilitation and Cognition in Alzheimer Patients
Acronym
RACO-MA
Official Title
Auditory Rehabilitation With Hearing Aids and Cognition in Alzheimer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
March 3, 2020 (Actual)
Study Completion Date
May 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Alzheimer disease is a neurodegenerative disease. Recent studies suggest that subjects with hearing loss are more likely to develop Alzheimer's disease. Hearing loss can be consecutive to presbycusis and/or to central auditory dysfunction. Standard audiometric measures with pure tone and speech intelligibility allow the diagnosis of presbycusis. However, to demonstrate central auditory dysfunction, specific audiometric tests as noisy and/or dichotic tests, are needed. Actually, no consensus exists to investigate hearing loss in people with Alzheimer's disease; therefore hearing loss may be an early manifestation of Alzheimer's disease. Until now, investigations and clinical procedure related to the diagnosis of Alzheimer's disease ignored the hearing ability of the patient. However, the major part of care management and investigations implies the patient's communication ability with caregivers. Hearing loss may be one of the most unrecognized deficit in subjects with Alzheimer's disease. Auditory rehabilitation with hearing aids could benefit to the patient to decrease cognitive decline but this management must be investigate during longitudinal studies in order to demonstrate their efficiency and need to be compared with a placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Hearing Loss
Keywords
Alzheimer, Hearing loss, Cognition, Quality of life, Hearing aids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients treated with hearing aids
Arm Type
Experimental
Arm Description
Patients fitted with functional hearing aids (Phonak Audéo BR)
Arm Title
Patients treated with placebo device
Arm Type
Placebo Comparator
Arm Description
Patients fitted with non-functional hearing aids
Intervention Type
Device
Intervention Name(s)
Hearing aids
Intervention Description
Phonak Audéo B-R (Target V 5.0)
Intervention Type
Device
Intervention Name(s)
Placebo
Other Intervention Name(s)
Non functional hearing aids
Intervention Description
Phonak Audéo B-R (Target V 5.0) without amplification
Primary Outcome Measure Information:
Title
Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale
Description
French scale validated by the french society of geriatry
Time Frame
Change before and one year after the fitting with device
Secondary Outcome Measure Information:
Title
air and bone auditory thresholds (dB HL) measured at 500, 1000, 2000, 3000 and 4000 Hz
Description
Tonal audiometry
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Title
Speech recognition threshold (dB HL) measured by speech audiometry
Description
Speech audiometry
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Title
Speech Discrimination Test (%) measured by speech audiometry
Description
Speech audiometry
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Title
Dichotic test measured with audiometry
Description
Speech audiometry
Time Frame
From 1 to 90 days prior the fitting with device
Title
Amplification with hearing aids or placebo devices measured by tonal and speech audiometry (dB HL)
Description
Audiometry
Time Frame
6 months after the fitting with device, 12 months after the fitting with device
Title
Devices tolerance measured with number of hours per day with hearing aids
Description
Audiometry
Time Frame
6 months after the fitting with device, 12 months after the fitting with device
Title
Objective auditory thresholds measured with auditory brainstem responses (ms)
Description
in case of uncooperative patients or to confirm tonal audiometry
Time Frame
6 months after the fitting with device, 12 months after the fitting with device
Title
Objective auditory thresholds measured by Auditory steady state responses (in dB eHL)
Description
in case of uncooperative patients or to confirm tonal audiometry
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Title
Mini Mental State Examination (30 items, total score from 0-30)
Description
French validated version
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Title
Hearing Handicap Inventory for Elderly measured by questionnaire (10 items, total score from 0-40)
Description
French validated version
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Title
Hearing loss impact scale in adults measured by 2 questionnaire (Abbreviated Profile of Hearing Aid Benefit, 24 items) and Impact of hearing loss in adults (20 items, total score from 0-200)
Description
French validated version
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Title
Quality of life-Alzheimer disease scale measured by questionnaire (total score from 13-52)
Description
French validated version
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Title
Assessing caregiver burden measured by Zarit scale (22 items, total score from 0-88)
Description
French validated version
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Title
Depression in the elderly measured by Geriatric depression scale (30 items, total score from 0-30)
Description
French validated version
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Title
Executive functions measured by trail making test
Description
French validated version
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Title
Working memory and processing speed measured by Wechsler Adult Intelligence Scale
Description
French validated version
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Title
Speech comprehension measured by Beauregard tests
Description
French validated version
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Title
Hearing aids tolerance measured by Glagow hearing-aid benefit questionnaire
Description
French validated version
Time Frame
From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Alzheimer patient Mini Mental state examination= 15-25 or mild cognitive impairment Over 65 yo Sensorineural hearing loss with pure tone average over 30 dB Language: French Able to sign the consent Affiliated to the French social security Exclusion Criteria: Conductive hearing loss Retrocochlear hearing loss History of neurological disorders with consequences in hearing loss (vascular accident; brain surgery, cerebral tumors, head trauma with loss consciousness) patient included in another study French no spoken chronic used of drugs or alcohol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DAVID BAKHOS, MCU-PU
Organizational Affiliation
University Hospital, Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Auditory Rehabilitation and Cognition in Alzheimer Patients

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