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

Sleep Disorder Clinical Trial

— MEMOWAVE  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04875442
• Other study ID #: 2020-A01806-33
• Status: Withdrawn
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: October 2023
• Source: BioSerenity
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• Memowave emitting sounds
Memowave is worn during one night and emits sounds to increase slow brain waves
• Memowave not emitting sounds
Memowave is worn during one night and doesn't emit sounds

Locations

Country	Name	City	State
France	ICM	Paris

Sponsors (1)

Lead Sponsor	Collaborator
BioSerenity

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 days
Secondary	Quality of the sleep	Score of 1 to 4 (where 4 is a good sleep and 1 a very bad sleep)	3 days
Secondary	efficiency on mnesic consolidation	memory grid .More the score is high, more the efficiency is better	3 days
Secondary	efficiency on mnesic consolidation	scale WAIS (Weschler Adult Intelligence scale). The score should be more than 100.	3 days