Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions

Study Overview
=================
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.

Official Title
-----------------
Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions MemoWave Aimed at Increasing Slow Brain Waves During Sleep to Improve Memory Consolidation in Subjects With Mild Cognitive Impairment

Conditions
-----------------
Sleep Disorder

Intervention / Treatment
-----------------
* Device: Memowave emitting sounds
* Device: Memowave not emitting sounds


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memowave emitting sound<br>Patients worn Memowave during one night, and the device emits sounds to increase slow brain signals | Device: Memowave emitting sounds<br>* Memowave is worn during one night and emits sounds to increase slow brain waves<br>|
| Placebo Comparator: Memowave not emitting sound<br>Patients worn Memowave during one night, and the device doesn't emit sounds | Device: Memowave not emitting sounds<br>* Memowave is worn during one night and doesn't emit sounds<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 3 days | 
| efficiency on mnesic consolidation | scale WAIS (Weschler Adult Intelligence scale). The score should be more than 100. | 3 days |