NCT04875442

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BioSerenity · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Disorder

Interventions

Type	Name	Description
DEVICE	Memowave emitting sounds	Memowave is worn during one night and emits sounds to increase slow brain waves
DEVICE	Memowave not emitting sounds	Memowave is worn during one night and doesn't emit sounds

Timeline

• Start date: 2023-10-30
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2021-05-06
• Last updated: 2023-10-24

Locations

1 site across 1 country: France