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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Sleep Disorder
• Intervention / Treatment: Device: Memowave emitting sounds; Device: Memowave not emitting sounds

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • ICM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Memowave emitting sound; Patients worn Memowave during one night, and the device emits sounds to increase slow brain signals	Device: Memowave emitting sounds; Memowave is worn during one night and emits sounds to increase slow brain waves
Placebo Comparator: Memowave not emitting sound; Patients worn Memowave during one night, and the device doesn't emit sounds	Device: Memowave not emitting sounds; Memowave is worn during one night and doesn't emit sounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: BioSerenity

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: May 2, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: 2020-A01806-33

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No