Clinical trial NCT03002142: Auditory Rehabilitation and Cognition in Alzheimer Patients
Official title: Auditory Rehabilitation With Hearing Aids and Cognition in Alzheimer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Hearing Loss
Keywords: Alzheimer
Hearing loss
Cognition
Quality of life
Hearing aids
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 9
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale
timeFrame: Change before and one year after the fitting with device
Secondary outcomes:
measure: air and bone auditory thresholds (dB HL) measured at 500, 1000, 2000, 3000 and 4000 Hz
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
measure: Speech recognition threshold (dB HL) measured by speech audiometry
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
measure: Speech Discrimination Test (%) measured by speech audiometry
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
measure: Dichotic test measured with audiometry
timeFrame: From 1 to 90 days prior the fitting with device
measure: Amplification with hearing aids or placebo devices measured by tonal and speech audiometry (dB HL)
timeFrame: 6 months after the fitting with device, 12 months after the fitting with device
measure: Devices tolerance measured with number of hours per day with hearing aids
timeFrame: 6 months after the fitting with device, 12 months after the fitting with device
measure: Objective auditory thresholds measured with auditory brainstem responses (ms)
timeFrame: 6 months after the fitting with device, 12 months after the fitting with device
measure: Objective auditory thresholds measured by Auditory steady state responses (in dB eHL)
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
measure: Mini Mental State Examination (30 items, total score from 0-30)
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
measure: Hearing Handicap Inventory for Elderly measured by questionnaire (10 items, total score from 0-40)
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
measure: 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)
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
measure: Quality of life-Alzheimer disease scale measured by questionnaire (total score from 13-52)
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
measure: Assessing caregiver burden measured by Zarit scale (22 items, total score from 0-88)
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
measure: Depression in the elderly measured by Geriatric depression scale (30 items, total score from 0-30)
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
measure: Executive functions measured by trail making test
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
measure: Working memory and processing speed measured by Wechsler Adult Intelligence Scale
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
measure: Speech comprehension measured by Beauregard tests
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
measure: Hearing aids tolerance measured by Glagow hearing-aid benefit questionnaire
timeFrame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Tours
name: DAVID BAKHOS, MCU-PU
role: PRINCIPAL_INVESTIGATOR
References: