Status:
WITHDRAWN
Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions
Lead Sponsor:
BioSerenity
Conditions:
Sleep Disorder
Eligibility:
All Genders
40-85 years
Phase:
NA
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 cognitiv...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04875442
Start Date
October 30 2023
End Date
December 30 2026
Last Update
October 24 2023
Active Locations (1)
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1
ICM
Paris, France, 75013