Alzheimer's Disease (AD)PINK-ADNCT04570761
Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study
A study testing Dreem headband in people with Alzheimer's Disease (AD), run by University Hospital, Tours at 1 site in France.
Trial summary
Alzheimer's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked to a deficit in consolidation. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease (AD)
- What is being tested?
- Dreem headband
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2021to 11 Mar 2024
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age> 50 years at the inclusion
- Patient with regular sleep patterns
- Patient having given written consent
- Patient affiliated to a social security regimen
- Patient with a beginning Alzheimer's disease defined according to the criteria of the National Institute on Aging-Alzheimer's Association or carriers of a prodromal Alzheimer's disease defined according to the criteria of the International Working Group IWG-2; the diagnosis must be supported by brain imaging and a blood test carried out in routine care
- MMSE score ≥ 24
Show all 18Show fewer
- Absence of neurodegenerative pathologies
- Matched in age (+/- 5 years) and in sex with a patient
- Non-inclusion criteria common to all participants:
- Psychiatric pathologies (except depression or anxiety disorders stabilized for more than 3 months)
- History of pathology which may have consequences on cognitive functioning and / or sleep: brain tumor, constituted stroke, epilepsy, head trauma (with clinical or parenchymal sequelae objectified on brain imagery), brain surgery
- Any significant comorbidity likely to constitute a confounding factor according to the clinician
- Psychotropic treatments introduced or modified <3 months before inclusion
- Hypnotic and / or sedative treatments
- Chronic consumption of alcohol or drugs
- Legal incapacity and / or other circumstance rendering the patient unable to understand the nature, objective or consequences of the study
- Major under guardianship or curatorship
- Patient not French-speaking by birth or illiterate
Who cannot join
- Sleep disorders defined by a score> 5 on the Pittsburg sleep quality index (PSQI)
- A score> 10 on the Epworth sleepiness index
Trial locations and contacts
1 site in 1 country.
About this study
Alzheimer's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked to a deficit in consolidation. Many studies indicate that sleep promotes this consolidation stage during the deep slow sleep stage by facilitating the transfer of information between the hippocampus and the neocortex.
A method of acoustic brain stimulation at night by pink noises has been recently developed and has shown its effectiveness in strengthening memory consolidation in healthy volunteers. Actually, there is no study observing the effect of this new stimulation method on populations with neurodegenerative pathologies, in particular in AD for which this technique could potentially become a therapeutic option.
The hypothesis is that of a strengthening of the memory consolidation capacities in subjects with AD as has been shown in healthy subjects.
Read the detailed description
Alzheimer's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked to a deficit in consolidation. Many studies indicate that sleep promotes this consolidation stage during the deep slow sleep stage by facilitating the transfer of information between the hippocampus and the neocortex.
A method of acoustic brain stimulation at night by pink noises has been recently developed and has shown its effectiveness in strengthening memory consolidation in healthy volunteers. Actually, there is no study observing the effect of this new stimulation method on populations with neurodegenerative pathologies, in particular in AD for which this technique could potentially become a therapeutic option.
The hypothesis is that of a strengthening of the memory consolidation capacities in subjects with AD as has been shown in healthy subjects.
- Conditions
- Alzheimer's Disease (AD)
- Being tested
- Dreem headband
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dreem headbandDevice
acoustic stimulation
Dreem headbandDevice
acoustic stimulation
| Study group | Role | What they receive |
|---|---|---|
| ON-Stim | Experimental | acoustic stimulation Receives: Device: Dreem headband |
| OFF-Stim | Sham comparator | no acoustic stimulation Receives: Device: Dreem headband |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
Measured: Day 7
difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
Measured: Day 8
difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
Measured: Day 14
difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
Measured: Day 15
Secondary outcomes (16)
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
Measured: Day 7
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
Measured: Day 8
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
Measured: Day 14
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
Measured: Day 15
The memory complaint for Mc Nair's Questionnaire
score from 0 to 156.156 control of a bad score. The variation between J0 and J15 will be studied.
Measured: Baseline
Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)
score from 0 to 60.60 control of a bad score. The variation between J0 and J15 will be studied.
Measured: Baseline
Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)
score from 0 to 56.56 control of a bad score. The variation between J0 and J15 will be studied.
Measured: Baseline
Quality of sleep for Pittsburgh Index (PSQI)
It is more an index of tolerance than efficiency. If the score is higher, the tolerance is lower.
Measured: Baseline
The memory complaint for Mc Nair's Questionnaire
score from 0 to 156.156 control of a bad score. The variation between J0 and J15 will be studied.
Measured: Day 15
Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)
score from 0 to 60.60 control of a bad score. The variation between J0 and J15 will be studied.
Measured: Day 15
Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)
score from 0 to 56.56 control of a bad score. The variation between J0 and J15 will be studied.
Measured: Day 15
Quality of sleep for Pittsburgh Index (PSQI)
It is more an index of tolerance than efficiency. If the score is higher, the tolerance is lower.
Measured: Day 15
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
gross variation in the amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition, on an ambulatory EEG device
Measured: Day 7
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
gross variation in the amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition, on an ambulatory EEG device
Measured: Day 8
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
gross variation in the amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition, on an ambulatory EEG device
Measured: Day 14
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
gross variation in the amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition, on an ambulatory EEG device
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start11 Mar 2021
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570761
- Sponsor's protocol ID
- DR200077
- Acronym
- PINK-AD
- Status last verified
- Oct 2023
- First submitted
- 8 Sep 2020
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study
- ClinicalTrials.gov ID
- NCT04570761
- Acronym / sponsor ID
- PINK-AD / DR200077
- Conditions
- Alzheimer's Disease (AD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 30 Sep 2020 (actual)
- 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's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked to a deficit in consolidation. Many studies indicate that sleep promotes this consolidation stage during the deep slow sleep stage by facilitating the transfer of information between the hippocampus and the neocortex.
A method of acoustic brain stimulation at night by pink noises has been recently developed and has shown its effectiveness in strengthening memory consolidation in healthy volunteers. Actually, there is no study observing the effect of this new stimulation method on populations with neurodegenerative pathologies, in particular in AD for which this technique could potentially become a therapeutic option.
The hypothesis is that of a strengthening of the memory consolidation capacities in subjects with AD as has been shown in healthy subjects.
Detailed description
Alzheimer's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked to a deficit in consolidation. Many studies indicate that sleep promotes this consolidation stage during the deep slow sleep stage by facilitating the transfer of information between the hippocampus and the neocortex.
A method of acoustic brain stimulation at night by pink noises has been recently developed and has shown its effectiveness in strengthening memory consolidation in healthy volunteers. Actually, there is no study observing the effect of this new stimulation method on populations with neurodegenerative pathologies, in particular in AD for which this technique could potentially become a therapeutic option.
The hypothesis is that of a strengthening of the memory consolidation capacities in subjects with AD as has been shown in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ON-Stim | Experimental | Device: Dreem headbandacoustic stimulation |
| OFF-Stim | Sham comparator | Device: Dreem headbandno acoustic stimulation |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age> 50 years at the inclusion
- Patient with regular sleep patterns
- Patient having given written consent
- Patient affiliated to a social security regimen
- Patient with a beginning Alzheimer's disease defined according to the criteria of the National Institute on Aging-Alzheimer's Association or carriers of a prodromal Alzheimer's disease defined according to the criteria of the International Working Group IWG-2; the diagnosis must be supported by brain imaging and a blood test carried out in routine care
Key exclusion criteria (2 listed)
- Sleep disorders defined by a score> 5 on the Pittsburg sleep quality index (PSQI)
- A score> 10 on the Epworth sleepiness index
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 |
|---|---|---|
| Dreem headbandacoustic stimulation | Device | ON-Stim |
| Dreem headbandacoustic stimulation | Device | OFF-Stim |
Primary outcome
difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
Time frame: Day 7
gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
Time frame: Day 8
gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
Time frame: Day 14
gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
Time frame: Day 15
gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
16 secondary outcomes
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
Time frame: Day 7
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
Time frame: Day 8
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
Time frame: Day 14
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
Time frame: Day 15
The memory complaint for Mc Nair's Questionnaire
Time frame: Baseline
Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)
Time frame: Baseline
Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)
Time frame: Baseline
Quality of sleep for Pittsburgh Index (PSQI)
Time frame: Baseline
The memory complaint for Mc Nair's Questionnaire
Time frame: Day 15
Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)
Time frame: Day 15
Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)
Time frame: Day 15
Quality of sleep for Pittsburgh Index (PSQI)
Time frame: Day 15
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
Time frame: Day 7
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
Time frame: Day 8
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
Time frame: Day 14
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
Time frame: Day 15
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 15 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dreem headband in people with Alzheimer's Disease (AD), 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 18 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 15 Jun 2026. 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?
difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching. (time frame: Day 7). The study lists 4 primary outcomes in all. 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 15 Jun 2026.