Alzheimer DiseaseNCT00488007
Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids
A study testing Hearing aids used : PHONAK Savia and Valeo in people with Alzheimer Disease and Presbycusis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Presbycusis
- What is being tested?
- Hearing aids used : PHONAK Savia and Valeo
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- May 2007to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- > 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
Who cannot join
- Beginning of an anticholinesterasic treatment in the last 6 months
- Change in the anticholinesterasic treatment in the last 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis
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
- Conditions
- Alzheimer Disease, Presbycusis
- Being tested
- Hearing aids used : PHONAK Savia and Valeo
- Keywords
- Alzheimer disease, Cognitive impairment, Sensorineural hearing loss, Hearing aids
- Medical subject headings
- Alzheimer Disease, Presbycusis, Cognitive Dysfunction, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Active Hearing aids | Experimental | Active Receives: Device: Hearing aids used : PHONAK Savia and Valeo |
| Inactive Hearing aids | Placebo comparator | Hearing aids turned off Receives: Device: Hearing aids used : PHONAK Savia and Valeo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive benefit evaluated thanks to the ADAS-Cog scale
Measured: Times of measurements: 0, 6th and 12th month
Secondary outcomes (4)
Cognitive scales: MMSE, Grober and Buschke, Digit symbol test
Measured: 0, 6th and 12th month
Behavioural scales: IADL, NPI
Measured: 1st week, 3rd 6th 9th and 12th month
Quality of life scales: Zarit scale and ADRQL
Measured: Zarit scale(every 2 months during the study time), ADRQL (0, 6th and 12th month)
Consumption questionnaire
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc BONNEFOY, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488007
- Sponsor's protocol ID
- 2006.414
- Status last verified
- Dec 2025
- First submitted
- 18 Jun 2007
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
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 28269769Nguyen 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis
- ClinicalTrials.gov ID
- NCT00488007
- Acronym / sponsor ID
- 2006.414
- Conditions
- Alzheimer Disease, Presbycusis
- Keywords
- Alzheimer disease, Cognitive impairment, Sensorineural hearing loss, Hearing aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Hearing aids | Experimental | Device: Hearing aids used : PHONAK Savia and ValeoActive |
| Inactive Hearing aids | Placebo comparator | Device: Hearing aids used : PHONAK Savia and ValeoHearing aids turned off |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (2 listed)
- Beginning of an anticholinesterasic treatment in the last 6 months
- Change in the anticholinesterasic treatment in the last 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing aids used : PHONAK Savia and Valeo5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active) | Device | Active Hearing aids, Inactive Hearing aids |
Primary outcome
Cognitive benefit evaluated thanks to the ADAS-Cog scale
Time frame: Times of measurements: 0, 6th and 12th month
4 secondary outcomes
Cognitive scales: MMSE, Grober and Buschke, Digit symbol test
Time frame: 0, 6th and 12th month
Behavioural scales: IADL, NPI
Time frame: 1st week, 3rd 6th 9th and 12th month
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)
Consumption questionnaire
Time frame: monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 28269769Adrait 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.
- Results publication: PubMed 28387664Nguyen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc BONNEFOY, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing aids used : PHONAK Savia and Valeo in people with Alzheimer Disease and Presbycusis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive benefit evaluated thanks to the ADAS-Cog scale (time frame: Times of measurements: 0, 6th and 12th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00488007, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.