Auditory Rehabilitation and Cognition in Alzheimer Patients

Alzheimer's Disease Clinical Trial

— RACO-MA  

Official title:

Auditory Rehabilitation With Hearing Aids and Cognition in Alzheimer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002142
• Other study ID #: PHRI15-DB/RACO-MA
• Status: Completed
• Phase: N/A
• Start date: March 31, 2017
• Est. completion date: May 3, 2020

Study information

• Verified date: May 2021
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Deafness
• Hearing Loss

Intervention

Device:
• Hearing aids
Phonak Audéo B-R (Target V 5.0)
• Placebo
Phonak Audéo B-R (Target V 5.0) without amplification

Locations

Country	Name	City	State
France	University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Dichotic test measured with audiometry	Speech audiometry	From 1 to 90 days prior the fitting with device
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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