ClinicalTrials.gg
CompletedNCT00488007Updated Dec 19, 2025

Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

An interventional study of Hearing aids used : PHONAK Savia and Valeo in Alzheimer Disease and Presbycusis, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Alzheimer Disease
  • Presbycusis

Keywords

  • Alzheimer disease
  • Cognitive impairment
  • Sensorineural hearing loss
  • Hearing aids
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's enrollment of 51 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Beginning of an anticholinesterasic treatment in the last 6 months
  • Change in the anticholinesterasic treatment in the last 2 months
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Active Hearing aids

    Active

    Device: Hearing aids used : PHONAK Savia and Valeo

  • Placebo comparator
    Inactive Hearing aids

    Hearing aids turned off

    Device: Hearing aids used : PHONAK Savia and Valeo

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)

06

What researchers measure

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

07

Study locations

1 site
  • Xavier PERROT
    Lyon, 69495, France
08

References and documents

Publications

  • 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. PubMed 28269769 ↗
  • 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. PubMed 28387664 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00488007
Responsible party
Sponsor
First posted
Jun 19, 2007
Start date
May 2007
Primary completion
Jun 2013
Completion
Sep 2013
Last update
Dec 19, 2025

Study contacts

Marc BONNEFOY, MD
principal investigator · Hospices Civils de Lyon

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion