Skip to main content
OpenTrials
Completed

NCT Number: NCT00488007

Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Presbycusis Sensation Disorders Signs and Symptoms Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xavier PERROT

Lyon, 69495, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Hearing aids used : PHONAK Savia and Valeo

Device

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

Primary outcomes

  1. Cognitive benefit evaluated thanks to the ADAS-Cog scale

    Time frame: Times of measurements: 0, 6th and 12th month

Secondary outcomes

  1. Cognitive scales: MMSE, Grober and Buschke, Digit symbol test

    Time frame: 0, 6th and 12th month

  2. Behavioural scales: IADL, NPI

    Time frame: 1st week, 3rd 6th 9th and 12th month

  3. Quality of life scales: Zarit scale and ADRQL

    Time frame: Zarit scale(every 2 months during the study time), ADRQL (0, 6th and 12th month)

  4. Consumption questionnaire

    Time frame: monthly

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jun 19, 2007
Registry last updated
Dec 19, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.