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OpenTrials
Completed

NCT Number: NCT03002142

Auditory Rehabilitation 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hearing aids

Device

Phonak Audéo B-R (Target V 5.0)

PLACEBO

Device

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

Other names: Non functional hearing aids

Primary outcomes

  1. Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale

    Time frame: Change before and one year after the fitting with device

    French scale validated by the french society of geriatry

Secondary outcomes

  1. air and bone auditory thresholds (dB HL) measured at 500, 1000, 2000, 3000 and 4000 Hz

    Time frame: 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

  2. Speech recognition threshold (dB HL) measured by speech audiometry

    Time frame: 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

  3. Speech Discrimination Test (%) measured by speech audiometry

    Time frame: 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

  4. Dichotic test measured with audiometry

    Time frame: From 1 to 90 days prior the fitting with device

    Speech audiometry

  5. Amplification with hearing aids or placebo devices measured by tonal and speech audiometry (dB HL)

    Time frame: 6 months after the fitting with device, 12 months after the fitting with device

    Audiometry

  6. Devices tolerance measured with number of hours per day with hearing aids

    Time frame: 6 months after the fitting with device, 12 months after the fitting with device

    Audiometry

  7. Objective auditory thresholds measured with auditory brainstem responses (ms)

    Time frame: 6 months after the fitting with device, 12 months after the fitting with device

    in case of uncooperative patients or to confirm tonal audiometry

  8. Objective auditory thresholds measured by Auditory steady state responses (in dB eHL)

    Time frame: 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

  9. Mini Mental State Examination (30 items, total score from 0-30)

    Time frame: 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

  10. Hearing Handicap Inventory for Elderly measured by questionnaire (10 items, total score from 0-40)

    Time frame: 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

  11. 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)

    Time frame: 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

  12. Quality of life-Alzheimer disease scale measured by questionnaire (total score from 13-52)

    Time frame: 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

  13. Assessing caregiver burden measured by Zarit scale (22 items, total score from 0-88)

    Time frame: 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

  14. Depression in the elderly measured by Geriatric depression scale (30 items, total score from 0-30)

    Time frame: 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

  15. Executive functions measured by trail making test

    Time frame: 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

  16. Working memory and processing speed measured by Wechsler Adult Intelligence Scale

    Time frame: 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

  17. Speech comprehension measured by Beauregard tests

    Time frame: 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

  18. Hearing aids tolerance measured by Glagow hearing-aid benefit questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Auditory Rehabilitation With Hearing Aids and Cognition in Alzheimer Patients

Acronym: RACO-MA

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 23, 2016
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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