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Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Alzheimer Disease
Presbycusis

Treatments

Device: Hearing aids used : PHONAK Savia and Valeo

Study type

Interventional

Funder types

Other

Identifiers

NCT00488007
2006.414

Details and patient eligibility

About

This is a 12-months' randomized clinical trial that aims at studying the benefit of bilateral hearing aids in hearing impaired patients suffering from a slight to moderate stage Alzheimer disease.

The benefit of this intervention will be studied in the cognitive, behavioural, quality of life and economic fields.

2groups are involved in this trial: Intervention group: 12 months' treatment with active hearing aids, fitted hearing impairment Control group: 6 months' treatment with placebo hearing aids, followed with 6 months' active hearing aids, fitted hearing impairment

Enrollment

51 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • > 65 year-old
  • Medical diagnosis of Alzheimer disease
  • 15 ≤ MMSE ≤ 25
  • No hearing aids in the last 2 years
  • Motivated caregiver living with the patient
  • Sensorineural hearing loss

Exclusion criteria

  • Beginning of an anticholinesterasic treatment in the last 6 months
  • Change in the anticholinesterasic treatment in the last 2 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

51 participants in 2 patient groups, including a placebo group

Active Hearing aids
Experimental group
Description:
Active
Treatment:
Device: Hearing aids used : PHONAK Savia and Valeo
Inactive Hearing aids
Placebo Comparator group
Description:
Hearing aids turned off
Treatment:
Device: Hearing aids used : PHONAK Savia and Valeo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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