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

BioSerenity

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Conditions

Sleep Disorder

Interventions

Memowave emitting soundsDEVICE

Memowave is worn during one night and emits sounds to increase slow brain waves

Memowave not emitting soundsDEVICE

Memowave is worn during one night and doesn't emit sounds

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

ICM

Paris, France

Outcomes

Primary Outcomes

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

Time frame: 3 days

Secondary Outcomes

Quality of the sleep

Score of 1 to 4 (where 4 is a good sleep and 1 a very bad sleep)

Time frame: 3 days

efficiency on mnesic consolidation

memory grid .More the score is high, more the efficiency is better

Time frame: 3 days

efficiency on mnesic consolidation

scale WAIS (Weschler Adult Intelligence scale). The score should be more than 100.

Time frame: 3 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.