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

Auditory Rehabilitation With Hearing Aids and Cognition in Alzheimer Patients

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Alzheimer's Disease
• Intervention / Treatment: Device: Hearing aids; Device: Placebo

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale	French scale validated by the french society of geriatry	Change before and one year after the fitting with device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
air and bone auditory thresholds (dB HL) measured at 500, 1000, 2000, 3000 and 4000 Hz	Tonal 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 recognition threshold (dB HL) measured by speech audiometry	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 Discrimination Test (%) measured by speech audiometry	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
Dichotic test measured with audiometry	Speech audiometry	From 1 to 90 days prior the fitting with device
Amplification with hearing aids or placebo devices measured by tonal and speech audiometry (dB HL)	Audiometry	6 months after the fitting with device, 12 months after the fitting with device
Devices tolerance measured with number of hours per day with hearing aids	Audiometry	6 months after the fitting with device, 12 months after the fitting with device
Objective auditory thresholds measured with auditory brainstem responses (ms)	in case of uncooperative patients or to confirm tonal audiometry	6 months after the fitting with device, 12 months after the fitting with device
Objective auditory thresholds measured by Auditory steady state responses (in dB eHL)	in case of uncooperative patients or to confirm tonal 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
Mini Mental State Examination (30 items, total score from 0-30)	French validated version	From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Hearing Handicap Inventory for Elderly measured by questionnaire (10 items, total score from 0-40)	French validated version	From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
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	From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Quality of life-Alzheimer disease scale measured by questionnaire (total score from 13-52)	French validated version	From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Assessing caregiver burden measured by Zarit scale (22 items, total score from 0-88)	French validated version	From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Depression in the elderly measured by Geriatric depression scale (30 items, total score from 0-30)	French validated version	From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Executive functions measured by trail making test	French validated version	From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Working memory and processing speed measured by Wechsler Adult Intelligence Scale	French validated version	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 comprehension measured by Beauregard tests	French validated version	From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Hearing aids tolerance measured by Glagow hearing-aid benefit questionnaire	French validated version	From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: DAVID BAKHOS, MCU-PU, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2017
• Primary Completion (ACTUAL): March 3, 2020
• Study Completion (ACTUAL): May 3, 2020

Study Registration Dates

• First Submitted: March 16, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (ESTIMATE): December 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Alzheimer; Cognition; Hearing loss; Hearing aids
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurocognitive Disorders; Otorhinolaryngologic Diseases; Neurodegenerative Diseases; Ear Diseases; Dementia; Tauopathies; Sensation Disorders; Hearing Disorders; Alzheimer Disease; Hearing Loss; Deafness
• Other Study ID Numbers: PHRI15-DB/RACO-MA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No