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Safety and performance study of the MemoWave electroencephalographic and sound recording device to increase slow brain waves during sleep to improve memory consolidation in subjects with mild cognitive impairment
24 subjects aged between 40 and 85 years, presenting a mild cognitive disorder of the amnesic type (ie a memory complaint, a Mini Mental State ≥ 24 and a score ≤26 on free recall or ≤45 / 48 on total recall of the RLRI16 test) will be included;
Each patient spends 3 polysomnography nights at hospital: 1 night of habituation without Memowave device and next 2 nights with Memovave.
The device emits sounds to increase slow brain waves but Memowave emits sounds during only one of the two nights of test (night placebo vs night "verum"). The attribution of the night is randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memowave emitting sound | Experimental | Patients worn Memowave during one night, and the device emits sounds to increase slow brain signals |
|
| Memowave not emitting sound | Placebo Comparator | Patients worn Memowave during one night, and the device doesn't emit sounds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memowave emitting sounds | Device | Memowave is worn during one night and emits sounds to increase slow brain waves |
|
| Measure | Description | Time Frame |
|---|---|---|
| accuracy of Electroencephalography signals of Memowave | number of slow waves of Memomave divided by number of slow waves of Gold standard should be under 1 | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of the sleep | Score of 1 to 4 (where 4 is a good sleep and 1 a very bad sleep) | 3 days |
| efficiency on mnesic consolidation | memory grid .More the score is high, more the efficiency is better |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICM | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The device studied is worn during the 2 polysomnogaphy nights. The device emits sounds during only one night in order to observe the difference of EEG signals.
The night during which the device emits sounds is determined by randomization. The nature of the second night with the device, will be the reverse of the first, in a crossover fashion.
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| Memowave not emitting sounds | Device | Memowave is worn during one night and doesn't emit sounds |
|
| 3 days |
| efficiency on mnesic consolidation | scale WAIS (Weschler Adult Intelligence scale). The score should be more than 100. | 3 days |
| D001523 | Mental Disorders |