Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sleep Disorder
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Other
Participation Requirements
- Age
- Between 40 years and 85 years
- Gender
- Both males and females
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 hospita...
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.
Tracking Information
- NCT #
- NCT04875442
- Collaborators
- Not Provided
- Investigators
- Not Provided
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