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

NCT ID: NCT04875442

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-30
• Study Completion Date: 2026-12-30

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.

Conditions

Sleep Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Memowave emitting sound

Patients worn Memowave during one night, and the device emits sounds to increase slow brain signals

Group Type: EXPERIMENTAL

Memowave emitting sounds

Intervention Type: DEVICE

Memowave is worn during one night and emits sounds to increase slow brain waves

Memowave not emitting sound

Patients worn Memowave during one night, and the device doesn't emit sounds

Group Type: PLACEBO_COMPARATOR

Memowave not emitting sounds

Intervention Type: DEVICE

Memowave is worn during one night and doesn't emit sounds

Interventions

Memowave emitting sounds

Memowave is worn during one night and emits sounds to increase slow brain waves

Intervention Type: DEVICE

Memowave not emitting sounds

Memowave is worn during one night and doesn't emit sounds

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioSerenity

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICM

Paris, , France

Countries

France

Other Identifiers

2020-A01806-33

Identifier Type: -

Identifier Source: org_study_id