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

Sleep Disorder Clinical Trial

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

Status Withdrawn

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Sleep Disorder
• Sleep Wake Disorders

• NCT number: NCT04875442
• Study type: Interventional
• Source: BioSerenity
• Status: Withdrawn
• Phase: N/A
• Start date: October 30, 2023
• Completion date: December 30, 2026