NCT07485153尚未招募不适用
A Study to Assess the Use of the Somfit, an Ambulatory Electroencephalogram-Based Digital Health Technology, Compared With Polysomnography to Evaluate Sleep Architecture in Individuals With Asymptomatic or Early Alzheimer's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Percentage of Agreement between Participants with the Same Results in Sleep Staging Using EEG and Sleep Study
研究概览
简要总结
The purpose of this study is to compare the results of two different sleep tests in Alzheimer's patients with no symptoms or early symptoms. Participants will undergo two simultaneous sleep tests (polysomnography) in a sleep laboratory for two nights and one sleep test at home for three nights. For each participant, the study will last at least a week and will last up to three months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have mild cognitive impairment, subjective memory complaints, or normal cognition.
- •Evidence of the presence of Alzheimer's pathology as measured by amyloid positron emission tomography (PET), cerebrospinal fluid biomarkers (amyloid beta and tau), or blood biomarkers.
- •Montreal Cognitive Assessment (MoCA) score of 24 or greater.
- •Clinical Dementia Rating Scale (CDR) global score of 0 or 0.
- •Able to provide signed informed consent.
- •On stable medications (including those for Alzheimer's disease) for 30 days before the first recording night of Study Period 1, and willing to remain on stable therapy during the study.
- •Must have a study partner who knows the participant well and can accompany the participant at visits where informant-rated scales are administered.
排除标准
- •Severe illness that in the investigator's judgement would adversely affect the participant's participation in the study.
- •Skin illness that may interfere with study assessments.
- •Has a pacemaker or implantable cardioverter defibrillator.
- •Diagnosed with a sleep disorder.
- •Has irregular circadian patterns (works night shifts, etc.).
- •Is pregnant or lactating/breastfeeding at time of screening.
- •Use of sleep aid medications (such as melatonin, Ambien, Lunestra) or other medications or substances that could affect sleep (alcohol, cannabinoids, or opioids) on nights of in-clinic and at-home recordings.
- •Currently enrolled in another clinical study involving an investigational product or other type of medical research judged not to be scientifically or medically compatible with this study.
- •People who habitually spend less than 5 hours in bed per night.
- •No alcohol will be allowed at least 24 hours before the use of the EEG and throughout the clinical assessment period.
结局指标
主要结局
Percentage of Agreement between Participants with the Same Results in Sleep Staging Using EEG and Sleep Study
时间窗: Night 1, Night 2
次要结局
未报告次要终点
研究者
研究点 (1)
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