Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
研究概览
简要总结
Alzheimer's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked to a deficit in consolidation. Many studies indicate that sleep promotes this consolidation stage during the deep slow sleep stage by facilitating the transfer of information between the hippocampus and the neocortex.
A method of acoustic brain stimulation at night by pink noises has been recently developed and has shown its effectiveness in strengthening memory consolidation in healthy volunteers. Actually, there is no study observing the effect of this new stimulation method on populations with neurodegenerative pathologies, in particular in AD for which this technique could potentially become a therapeutic option.
The hypothesis is that of a strengthening of the memory consolidation capacities in subjects with AD as has been shown in healthy subjects.
详细描述
Alzheimer's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked to a deficit in consolidation. Many studies indicate that sleep promotes this consolidation stage during the deep slow sleep stage by facilitating the transfer of information between the hippocampus and the neocortex.
A method of acoustic brain stimulation at night by pink noises has been recently developed and has shown its effectiveness in strengthening memory consolidation in healthy volunteers. Actually, there is no study observing the effect of this new stimulation method on populations with neurodegenerative pathologies, in particular in AD for which this technique could potentially become a therapeutic option.
The hypothesis is that of a strengthening of the memory consolidation capacities in subjects with AD as has been shown in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •common to all participants:
- •Age> 50 years at the inclusion
- •Patient with regular sleep patterns
- •Patient having given written consent
- •Patient affiliated to a social security regimen
- •Inclusion criteria for subjects with Alzheimer's disease:
- •Patient with a beginning Alzheimer's disease defined according to the criteria of the National Institute on Aging-Alzheimer's Association or carriers of a prodromal Alzheimer's disease defined according to the criteria of the International Working Group IWG-2; the diagnosis must be supported by brain imaging and a blood test carried out in routine care
- •MMSE score ≥ 24
- •Inclusion criteria for healthy volunteers:
- •Absence of neurodegenerative pathologies
- •Matched in age (+/- 5 years) and in sex with a patient
- •Non-inclusion criteria common to all participants:
- •Psychiatric pathologies (except depression or anxiety disorders stabilized for more than 3 months)
- •History of pathology which may have consequences on cognitive functioning and / or sleep: brain tumor, constituted stroke, epilepsy, head trauma (with clinical or parenchymal sequelae objectified on brain imagery), brain surgery
- •Any significant comorbidity likely to constitute a confounding factor according to the clinician
- •Psychotropic treatments introduced or modified <3 months before inclusion
- •Hypnotic and / or sedative treatments
- •Chronic consumption of alcohol or drugs
- •Legal incapacity and / or other circumstance rendering the patient unable to understand the nature, objective or consequences of the study
- •Major under guardianship or curatorship
- •Patient not French-speaking by birth or illiterate
排除标准
- •common to all participants:
- •Sleep disorders defined by a score> 5 on the Pittsburg sleep quality index (PSQI)
- •A score> 10 on the Epworth sleepiness index
结局指标
主要结局
difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
时间窗: Day 15
gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
次要结局
- amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition(Day 15)
- The memory complaint for Mc Nair's Questionnaire(Day 15)
- Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)(Day 15)
- Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)(Day 15)
- Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.(Day 15)
- Quality of sleep for Pittsburgh Index (PSQI)(Day 15)