Sleep Disorder
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICEMemowave emitting sounds
Memowave is worn during one night and emits sounds to increase slow brain waves
DEVICEMemowave not emitting sounds
Memowave is worn during one night and doesn't emit sounds
Sponsors
BioSerenity
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subject presenting a mild cognitive disorder of the amnesic type, defined by a memory complaint, a Mini Mental State ≥ 24 and a score ≤26 on free recall or ≤45 / 48 on total recall) of the RLRI16 episodic verbal memory test * At least 7 years of schooling
Exclusion criteria
* Severe psychiatric pathology * Known neurological pathology * High risk of apnea syndrome defined by at least 2 positive categories (each with a score ≥2) on the Berlin Questionnaire for Apnea Syndrome Screening * High risk of behavioral disorder in REM sleep defined by an RBDSQ score\> 5. * Taking sleeping pills or antidepressants * Severe heart disease or unbalanced diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| accuracy of Electroencephalography signals of Memowave | 3 days | number of slow waves of Memomave divided by number of slow waves of Gold standard should be under 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of the sleep | 3 days | Score of 1 to 4 (where 4 is a good sleep and 1 a very bad sleep) |
| efficiency on mnesic consolidation | 3 days | memory grid .More the score is high, more the efficiency is better |
Countries
France
Outcome results
None listed