Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

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

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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