Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions (MEMOWAVE)

BioSerenity

Status: Withdrawn

Conditions: Sleep Disorder

Treatments: Device: Memowave not emitting sounds; Device: Memowave emitting sounds

Study type: Interventional

Funder types: Industry

Identifiers

NCT04875442

2020-A01806-33

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Memowave emitting sound

Experimental group

Description:

Patients worn Memowave during one night, and the device emits sounds to increase slow brain signals

Treatment:

Device: Memowave emitting sounds

Memowave not emitting sound

Placebo Comparator group

Description:

Patients worn Memowave during one night, and the device doesn't emit sounds

Treatment:

Device: Memowave not emitting sounds