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

NCT04875442 | Withdrawn

• 1 other identifier: 2020-A01806-33
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of the sleep

  3 days

• efficiency on mnesic consolidation

  3 days

• efficiency on mnesic consolidation

  3 days

Study Arms (2)

Memowave emitting sound

EXPERIMENTAL

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

Device: Memowave emitting sounds

Memowave not emitting sound

PLACEBO COMPARATOR

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

Device: Memowave not emitting sounds

Interventions

Memowave emitting sounds DEVICE

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

Memowave emitting sound

Memowave not emitting sounds DEVICE

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

Memowave not emitting sound

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioSerenity: lead

Study Sites (1)

ICM

Paris, 75013, France

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The device studied is worn during the 2 polysomnogaphy nights. The device emits sounds during only one night in order to observe the difference of EEG signals. The night during which the device emits sounds is determined by randomization. The nature of the second night with the device, will be the reverse of the first, in a crossover fashion.

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: May 6, 2021
• Study Start: October 30, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

FR (1)