RACO-MA: Auditory Rehabilitation and Cognition in Alzheimer Patients

Sponsor

University Hospital, Tours (Other)

Overall Status

Completed

CT.gov ID

NCT03002142

Collaborator

(none)

Enrollment

Location

Arms

37.1

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease Hearing Loss	Device: Hearing aids Device: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Auditory Rehabilitation With Hearing Aids and Cognition in Alzheimer Patients

Actual Study Start Date :

Mar 31, 2017

Actual Primary Completion Date :

Mar 3, 2020

Actual Study Completion Date :

May 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients treated with hearing aids Patients fitted with functional hearing aids (Phonak Audéo BR)	Device: Hearing aids Phonak Audéo B-R (Target V 5.0)
Placebo Comparator: Patients treated with placebo device Patients fitted with non-functional hearing aids	Device: Placebo Phonak Audéo B-R (Target V 5.0) without amplification Other Names: Non functional hearing aids

Arm

Intervention/Treatment

Experimental: Patients treated with hearing aids

Patients fitted with functional hearing aids (Phonak Audéo BR)

Device: Hearing aids

Phonak Audéo B-R (Target V 5.0)

Placebo Comparator: Patients treated with placebo device

Patients fitted with non-functional hearing aids

Device: Placebo

Phonak Audéo B-R (Target V 5.0) without amplification

Other Names:

Non functional hearing aids

Outcome Measures

Primary Outcome Measures

Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale [Change before and one year after the fitting with device]
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 [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
Tonal audiometry
Speech recognition threshold (dB HL) measured by speech audiometry [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
Speech audiometry
Speech Discrimination Test (%) measured by speech audiometry [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
Speech audiometry
Dichotic test measured with audiometry [From 1 to 90 days prior the fitting with device]
Speech audiometry
Amplification with hearing aids or placebo devices measured by tonal and speech audiometry (dB HL) [6 months after the fitting with device, 12 months after the fitting with device]
Audiometry
Devices tolerance measured with number of hours per day with hearing aids [6 months after the fitting with device, 12 months after the fitting with device]
Audiometry
Objective auditory thresholds measured with auditory brainstem responses (ms) [6 months after the fitting with device, 12 months after the fitting with device]
in case of uncooperative patients or to confirm tonal audiometry
Objective auditory thresholds measured by Auditory steady state responses (in dB eHL) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
in case of uncooperative patients or to confirm tonal audiometry
Mini Mental State Examination (30 items, total score from 0-30) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
French validated version
Hearing Handicap Inventory for Elderly measured by questionnaire (10 items, total score from 0-40) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
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) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
French validated version
Quality of life-Alzheimer disease scale measured by questionnaire (total score from 13-52) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
French validated version
Assessing caregiver burden measured by Zarit scale (22 items, total score from 0-88) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
French validated version
Depression in the elderly measured by Geriatric depression scale (30 items, total score from 0-30) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
French validated version
Executive functions measured by trail making test [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
French validated version
Working memory and processing speed measured by Wechsler Adult Intelligence Scale [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
French validated version
Speech comprehension measured by Beauregard tests [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
French validated version
Hearing aids tolerance measured by Glagow hearing-aid benefit questionnaire [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
French validated version

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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