NCT00488007

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2007

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

6.1 years

First QC Date

June 18, 2007

Last Update Submit

December 13, 2025

Conditions

Alzheimer DiseasePresbycusis

Keywords

Alzheimer diseaseCognitive impairmentSensorineural hearing lossHearing aids

Outcome Measures

Primary Outcomes (1)

  • Cognitive benefit evaluated thanks to the ADAS-Cog scale

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

Secondary Outcomes (4)

  • 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

Study Arms (2)

Active Hearing aids

EXPERIMENTAL

Active

Device: Hearing aids used : PHONAK Savia and Valeo

Inactive Hearing aids

PLACEBO COMPARATOR

Hearing aids turned off

Device: Hearing aids used : PHONAK Savia and Valeo

Interventions

Hearing aids used : PHONAK Savia and ValeoDEVICE

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

Active Hearing aidsInactive Hearing aids

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xavier PERROT

Lyon, 69495, France

Location

Related Publications (2)

  • Adrait A, Perrot X, Nguyen MF, Gueugnon M, Petitot C, Collet L, Roux A, Bonnefoy M; ADPHA study group. Do Hearing Aids Influence Behavioral and Psychological Symptoms of Dementia and Quality of Life in Hearing Impaired Alzheimer's Disease Patients and Their Caregivers? J Alzheimers Dis. 2017;58(1):109-121. doi: 10.3233/JAD-160792.

    PMID: 28269769RESULT

  • Nguyen MF, Bonnefoy M, Adrait A, Gueugnon M, Petitot C, Collet L, Roux A, Perrot X; ADPHA study group. Efficacy of Hearing Aids on the Cognitive Status of Patients with Alzheimer's Disease and Hearing Loss: A Multicenter Controlled Randomized Trial. J Alzheimers Dis. 2017;58(1):123-137. doi: 10.3233/JAD-160793.

    PMID: 28387664RESULT

MeSH Terms

Conditions

Alzheimer DiseasePresbycusisCognitive DysfunctionHearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCognition Disorders

Study Officials

  • Marc BONNEFOY, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2007

First Posted

June 19, 2007

Study Start

May 1, 2007

Primary Completion

June 1, 2013

Study Completion

September 1, 2013

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

FR(1)