Alzheimer's DiseaseRACO-MANCT03002142
Auditory Rehabilitation and Cognition in Alzheimer Patients
A study testing Hearing aids in people with Alzheimer's Disease and Hearing Loss, run by University Hospital, Tours at 1 site in France.
Trial summary
Alzheimer disease is a neurodegenerative disease. Recent studies suggest that subjects with hearing loss are more likely to develop Alzheimer's disease. Hearing loss can be consecutive to presbycusis and/or to central auditory dysfunction. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer's Disease, Hearing Loss
- What is being tested?
- Hearing aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2017to 3 May 2020
- 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
- Alzheimer patient
- Mini Mental state examination= 15-25 or mild cognitive impairment
- Over 65 yo
- Sensorineural hearing loss with pure tone average over 30 dB
- Language: French
- Able to sign the consent
- Affiliated to the French social security
Who cannot join
- Conductive hearing loss
- Retrocochlear hearing loss
- History of neurological disorders with consequences in hearing loss (vascular accident; brain surgery, cerebral tumors, head trauma with loss consciousness)
- patient included in another study
- French no spoken
- chronic used of drugs or alcohol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Auditory Rehabilitation With Hearing Aids and Cognition in Alzheimer Patients
Alzheimer disease is a neurodegenerative disease. Recent studies suggest that subjects with hearing loss are more likely to develop Alzheimer's disease. Hearing loss can be consecutive to presbycusis and/or to central auditory dysfunction.
Standard audiometric measures with pure tone and speech intelligibility allow the diagnosis of presbycusis. However, to demonstrate central auditory dysfunction, specific audiometric tests as noisy and/or dichotic tests, are needed.
Actually, no consensus exists to investigate hearing loss in people with Alzheimer's disease; therefore hearing loss may be an early manifestation of Alzheimer's disease. Until now, investigations and clinical procedure related to the diagnosis of Alzheimer's disease ignored the hearing ability of the patient. However, the major part of care management and investigations implies the patient's communication ability with caregivers. Hearing loss may be one of the most unrecognized deficit in subjects with Alzheimer's disease. Auditory rehabilitation with hearing aids could benefit to the patient to decrease cognitive decline but this management must be investigate during longitudinal studies in order to demonstrate their efficiency and need to be compared with a placebo.
- Conditions
- Alzheimer's Disease, Hearing Loss
- Being tested
- Hearing aids, Placebo
- Keywords
- Alzheimer, Hearing loss, Cognition, Quality of life, Hearing aids
- Medical subject headings
- Alzheimer Disease, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aidsDevice
Phonak Audéo B-R (Target V 5.0)
PlaceboDevice
Also called Non functional hearing aids
Phonak Audéo B-R (Target V 5.0) without amplification
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with hearing aids | Experimental | Patients fitted with functional hearing aids (Phonak Audéo BR) Receives: Device: Hearing aids |
| Patients treated with placebo device | Placebo comparator | Patients fitted with non-functional hearing aids Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale
French scale validated by the french society of geriatry
Measured: Change before and one year after the fitting with device
Secondary outcomes (18)
air and bone auditory thresholds (dB HL) measured at 500, 1000, 2000, 3000 and 4000 Hz
Tonal audiometry
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Speech recognition threshold (dB HL) measured by speech audiometry
Speech audiometry
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Speech Discrimination Test (%) measured by speech audiometry
Speech audiometry
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Dichotic test measured with audiometry
Speech audiometry
Measured: From 1 to 90 days prior the fitting with device
Amplification with hearing aids or placebo devices measured by tonal and speech audiometry (dB HL)
Audiometry
Measured: 6 months after the fitting with device, 12 months after the fitting with device
Devices tolerance measured with number of hours per day with hearing aids
Audiometry
Measured: 6 months after the fitting with device, 12 months after the fitting with device
Objective auditory thresholds measured with auditory brainstem responses (ms)
in case of uncooperative patients or to confirm tonal audiometry
Measured: 6 months after the fitting with device, 12 months after the fitting with device
Objective auditory thresholds measured by Auditory steady state responses (in dB eHL)
in case of uncooperative patients or to confirm tonal audiometry
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Mini Mental State Examination (30 items, total score from 0-30)
French validated version
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Hearing Handicap Inventory for Elderly measured by questionnaire (10 items, total score from 0-40)
French validated version
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Hearing loss impact scale in adults measured by 2 questionnaire (Abbreviated Profile of Hearing Aid Benefit, 24 items) and Impact of hearing loss in adults (20 items, total score from 0-200)
French validated version
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Quality of life-Alzheimer disease scale measured by questionnaire (total score from 13-52)
French validated version
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Assessing caregiver burden measured by Zarit scale (22 items, total score from 0-88)
French validated version
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Depression in the elderly measured by Geriatric depression scale (30 items, total score from 0-30)
French validated version
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Executive functions measured by trail making test
French validated version
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Working memory and processing speed measured by Wechsler Adult Intelligence Scale
French validated version
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Speech comprehension measured by Beauregard tests
French validated version
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Hearing aids tolerance measured by Glagow hearing-aid benefit questionnaire
French validated version
Measured: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start31 Mar 2017
- Primary completion3 Mar 2020
- Study completion3 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DAVID BAKHOS, MCU-PU, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002142
- Sponsor's protocol ID
- PHRI15-DB/RACO-MA
- Acronym
- RACO-MA
- Status last verified
- May 2021
- First submitted
- 16 Mar 2016
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Rehabilitation With Hearing Aids and Cognition in Alzheimer Patients
- ClinicalTrials.gov ID
- NCT03002142
- Acronym / sponsor ID
- RACO-MA / PHRI15-DB/RACO-MA
- Conditions
- Alzheimer's Disease, Hearing Loss
- Keywords
- Alzheimer, Hearing loss, Cognition, Quality of life, Hearing aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 May 2020 (actual)
- First posted
- 23 Dec 2016 (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.
Alzheimer disease is a neurodegenerative disease. Recent studies suggest that subjects with hearing loss are more likely to develop Alzheimer's disease. Hearing loss can be consecutive to presbycusis and/or to central auditory dysfunction.
Standard audiometric measures with pure tone and speech intelligibility allow the diagnosis of presbycusis. However, to demonstrate central auditory dysfunction, specific audiometric tests as noisy and/or dichotic tests, are needed.
Actually, no consensus exists to investigate hearing loss in people with Alzheimer's disease; therefore hearing loss may be an early manifestation of Alzheimer's disease. Until now, investigations and clinical procedure related to the diagnosis of Alzheimer's disease ignored the hearing ability of the patient. However, the major part of care management and investigations implies the patient's communication ability with caregivers. Hearing loss may be one of the most unrecognized deficit in subjects with Alzheimer's disease. Auditory rehabilitation with hearing aids could benefit to the patient to decrease cognitive decline but this management must be investigate during longitudinal studies in order to demonstrate their efficiency and need to be compared with a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with hearing aids | Experimental | Device: Hearing aidsPatients fitted with functional hearing aids (Phonak Audéo BR) |
| Patients treated with placebo device | Placebo comparator | Device: PlaceboPatients fitted with non-functional hearing aids |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Alzheimer patient
- Mini Mental state examination= 15-25 or mild cognitive impairment
- Over 65 yo
- Sensorineural hearing loss with pure tone average over 30 dB
- Language: French
Key exclusion criteria (6 listed)
- Conductive hearing loss
- Retrocochlear hearing loss
- History of neurological disorders with consequences in hearing loss (vascular accident; brain surgery, cerebral tumors, head trauma with loss consciousness)
- patient included in another study
- French no spoken
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 aidsPhonak Audéo B-R (Target V 5.0) | Device | Patients treated with hearing aids |
| PlaceboAlso: Non functional hearing aidsPhonak Audéo B-R (Target V 5.0) without amplification | Device | Patients treated with placebo device |
Primary outcome
Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale
Time frame: Change before and one year after the fitting with device
French scale validated by the french society of geriatry
18 secondary outcomes
air and bone auditory thresholds (dB HL) measured at 500, 1000, 2000, 3000 and 4000 Hz
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Speech recognition threshold (dB HL) measured by speech audiometry
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Speech Discrimination Test (%) measured by speech audiometry
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Dichotic test measured with audiometry
Time frame: From 1 to 90 days prior the fitting with device
Amplification with hearing aids or placebo devices measured by tonal and speech audiometry (dB HL)
Time frame: 6 months after the fitting with device, 12 months after the fitting with device
Devices tolerance measured with number of hours per day with hearing aids
Time frame: 6 months after the fitting with device, 12 months after the fitting with device
Objective auditory thresholds measured with auditory brainstem responses (ms)
Time frame: 6 months after the fitting with device, 12 months after the fitting with device
Objective auditory thresholds measured by Auditory steady state responses (in dB eHL)
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Mini Mental State Examination (30 items, total score from 0-30)
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Hearing Handicap Inventory for Elderly measured by questionnaire (10 items, total score from 0-40)
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Hearing loss impact scale in adults measured by 2 questionnaire (Abbreviated Profile of Hearing Aid Benefit, 24 items) and Impact of hearing loss in adults (20 items, total score from 0-200)
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Quality of life-Alzheimer disease scale measured by questionnaire (total score from 13-52)
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Assessing caregiver burden measured by Zarit scale (22 items, total score from 0-88)
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Depression in the elderly measured by Geriatric depression scale (30 items, total score from 0-30)
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Executive functions measured by trail making test
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Working memory and processing speed measured by Wechsler Adult Intelligence Scale
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Speech comprehension measured by Beauregard tests
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
Hearing aids tolerance measured by Glagow hearing-aid benefit questionnaire
Time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
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 12 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
DAVID BAKHOS, MCU-PU principal investigator
University Hospital, Tours
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 in people with Alzheimer's Disease and Hearing Loss, run by University Hospital, Tours 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 7 inclusion and 6 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 12 May 2021. 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?
Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale (time frame: Change before and one year after the fitting with device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2021.