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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- BioSerenity
- 试验地点
- 1
- 主要终点
- accuracy of Electroencephalography signals of Memowave
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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>
- •Taking sleeping pills or antidepressants
- •Severe heart disease or unbalanced diabetes
研究组 & 干预措施
Memowave emitting sound
Patients worn Memowave during one night, and the device emits sounds to increase slow brain signals
干预措施: Memowave emitting sounds (Device)
Memowave not emitting sound
Patients worn Memowave during one night, and the device doesn't emit sounds
干预措施: Memowave not emitting sounds (Device)
结局指标
主要结局
accuracy of Electroencephalography signals of Memowave
时间窗: 3 days
number of slow waves of Memomave divided by number of slow waves of Gold standard should be under 1
次要结局
- efficiency on mnesic consolidation(3 days)
- Quality of the sleep(3 days)