Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00488007

Enrollment

Registered

2007-06-19

Start date

2007-05-31

Completion date

2013-09-30

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Presbycusis

Keywords

Alzheimer disease, Cognitive impairment, Sensorineural hearing loss, Hearing aids

Brief summary

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

Interventions

DEVICEHearing aids used : PHONAK Savia and Valeo

5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Cognitive benefit evaluated thanks to the ADAS-Cog scale	Times of measurements: 0, 6th and 12th month

Secondary

Measure	Time frame
Cognitive scales: MMSE, Grober and Buschke, Digit symbol test	0, 6th and 12th month
Behavioural scales: IADL, NPI	1st week, 3rd 6th 9th and 12th month
Quality of life scales: Zarit scale and ADRQL	Zarit scale(every 2 months during the study time), ADRQL (0, 6th and 12th month)
Consumption questionnaire	monthly

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026