Back to resultsSafety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions (MEMOWAVE)
Primary Purpose
Sleep Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Memowave emitting sounds
Memowave not emitting sounds
Sponsored by
About this trial
This is an interventional other trial for Sleep Disorder
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
Sites / Locations
- ICM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Memowave emitting sound
Memowave not emitting sound
Arm Description
Patients worn Memowave during one night, and the device emits sounds to increase slow brain signals
Patients worn Memowave during one night, and the device doesn't emit sounds
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Quality of the sleep
Score of 1 to 4 (where 4 is a good sleep and 1 a very bad sleep)
efficiency on mnesic consolidation
memory grid .More the score is high, more the efficiency is better
efficiency on mnesic consolidation
scale WAIS (Weschler Adult Intelligence scale). The score should be more than 100.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04875442
Brief Title
Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
PROJECT STOPPED
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioSerenity
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Memowave emitting sound
Arm Type
Experimental
Arm Description
Patients worn Memowave during one night, and the device emits sounds to increase slow brain signals
Arm Title
Memowave not emitting sound
Arm Type
Placebo Comparator
Arm Description
Patients worn Memowave during one night, and the device doesn't emit sounds
Intervention Type
Device
Intervention Name(s)
Memowave emitting sounds
Intervention Description
Memowave is worn during one night and emits sounds to increase slow brain waves
Intervention Type
Device
Intervention Name(s)
Memowave not emitting sounds
Intervention Description
Memowave is worn during one night and doesn't emit sounds
Primary Outcome Measure Information:
Title
accuracy of Electroencephalography signals of Memowave
Description
number of slow waves of Memomave divided by number of slow waves of Gold standard should be under 1
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Quality of the sleep
Description
Score of 1 to 4 (where 4 is a good sleep and 1 a very bad sleep)
Time Frame
3 days
Title
efficiency on mnesic consolidation
Description
memory grid .More the score is high, more the efficiency is better
Time Frame
3 days
Title
efficiency on mnesic consolidation
Description
scale WAIS (Weschler Adult Intelligence scale). The score should be more than 100.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
ICM
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Learn more about this trial
Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions
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