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

Not Applicable

Withdrawn

• Conditions: Sleep Disorder
• Interventions: Device: Memowave not emitting sounds; Device: Memowave emitting sounds

• Registration Number: NCT04875442
• Lead Sponsor: BioSerenity

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.

Study Timeline

• Study First Submitted: 2020-12-10
• Study First Submitted QC: 2021-05-02
• Study First Posted: 2021-05-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-24
• Study Start: 2023-10-30
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Memowave not emitting sound	Memowave not emitting sounds	Patients worn Memowave during one night, and the device doesn't emit sounds
Memowave emitting sound	Memowave emitting sounds	Patients worn Memowave during one night, and the device emits sounds to increase slow brain signals

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
efficiency on mnesic consolidation	3 days	scale WAIS (Weschler Adult Intelligence scale). The score should be more than 100.
Quality of the sleep	3 days	Score of 1 to 4 (where 4 is a good sleep and 1 a very bad sleep)

Trial Locations

Locations (1)

ICM; 🇫🇷 Paris, France