Sleep Quality and Amyloid-Beta Kinetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Compared to Those With Good Sleep Efficiency as Measured by ng/ml
研究概览
简要总结
The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) by modification of sleep efficiency.
详细描述
The purpose of the study is to investigate whether or not increasing sleep efficiency will change the concentration of amyloid-beta in cerebrospinal fluid (CSF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 45-65 years
- •Any race/ethnicity
- •Mini-Mental Status Examination score (MMSE) >=27
- •Sleep efficiency measured by actigraphy to determine good sleeper or poor sleeper
排除标准
- •Cognitive impairment as determined by history of MMSE < 27
- •Inability to speak or understand English
- •Any sleep disorders other than insomnia
- •history of sleep-disordered breathing
- •STOP-Bang score > 3
- •History or reported symptoms suggestive of restless legs syndrome, narcolepsy or other sleep disorders
- •Sleep schedule outside the range of bedtime 8PM-12AM and wake time 4AM-9AM
- •Contraindication to lumbar catheter (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery)
- •Cardiovascular disease requiring medication except for controlled hypertension (PI discretion)
- •Hepatic or renal impairment
- •Pulmonary disease (PI discretion)
- •Type 1 diabetes
- •HIV or AIDS
- •Neurologic or psychiatric disorder requiring medication (PI discretion)
- •Alcohol or tobacco use (PI discretion)
- •Use of sedating medications
- •Inability to get out of bed independently
- •Abnormal movement of the non-dominant arm (would affect actigraphy data in unpredictable ways)
- •Abnormal physical examination
- •Current pregnancy
- •History of migraine headaches (PI discretion)
- •History of drug abuse in the past 6 months
- •Urinary or fecal incontinence
- •Difficulty sleeping in an unfamiliar environment (good sleep quality group only)
- •History or presence of any clinically significant medication condition, behavioral or psychiatric condition (including suicidal ideation), or surgical history based on medical record or patient report that could affect the safety of the subject or interfere with study assessments or in the judgment of the PI is not a good candidate
研究组 & 干预措施
Poor sleep group treatment 1
10mg Suvorexant tablet h.s. for two consecutive nights
干预措施: Suvorexant (Drug)
Poor sleep group control
Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.
干预措施: Placebo (Drug)
Good sleep group
Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.
干预措施: Placebo (Drug)
Poor sleep group treatment 2
20mg Suvorexant tablet h.s. for two consecutive nights
干预措施: Suvorexant (Drug)
结局指标
主要结局
Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Compared to Those With Good Sleep Efficiency as Measured by ng/ml
时间窗: 36 hours of CSF collection
Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency (Poor sleep group control) compared to those with good sleep efficiency (Good sleep group)
Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Treated With Placebo, Suvorexant 10 mg, or Suvorexant 20 mg as Measured by ng/ml
时间窗: 36 hours of CSF collection
Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency who were treated with placebo (Poor sleep group control), Suvorexant 10 mg (Poor sleep group treatment 1), and Suvorexant 20 mg (Poor sleep group treatment 2)
次要结局
未报告次要终点