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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ON-Stim | Experimental | acoustic stimulation |
|
| OFF-Stim | Sham Comparator | no acoustic stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dreem headband | Device | acoustic stimulation |
| |
| Dreem headband |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 7 |
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Inclusion Criteria common to all participants:
Inclusion criteria for subjects with Alzheimer's disease:
Inclusion criteria for healthy volunteers:
Non-inclusion criteria common to all participants:
Exclusion Criteria common to all participants:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Tours | Tours | 37044 | France |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Device |
acoustic stimulation |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | Day 15 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |