Auditory Rehabilitation and Cognition in Alzheimer Patients

NCT03002142 | Completed DMC

• 1 other identifier: PHRI15-DB/RACO-MA
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease; Hearing Loss

Keywords

Alzheimer; Hearing loss; Cognition; Quality of life; Hearing aids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• 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

• 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 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

• Dichotic test measured with 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)

  6 months after the fitting with device, 12 months after the fitting with device

Study Arms (2)

Patients treated with hearing aids

EXPERIMENTAL

Patients fitted with functional hearing aids (Phonak Audéo BR)

Device: Hearing aids

Patients treated with placebo device

PLACEBO COMPARATOR

Patients fitted with non-functional hearing aids

Device: Placebo

Interventions

Hearing aids DEVICE

Phonak Audéo B-R (Target V 5.0)

Patients treated with hearing aids

Placebo DEVICE

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

Also known as: Non functional hearing aids

Patients treated with placebo device

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

University Hospital

Tours, 37044, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Officials

• DAVID BAKHOS, MCU-PU

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: December 23, 2016
• Study Start: March 31, 2017
• Primary Completion: March 3, 2020
• Study Completion: May 3, 2020
• Last Updated: May 12, 2021

Record last verified: 2021-05

Locations

FR (1)