Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Percent Increase From Mean Baseline (07:00 to 19:00) of Cerebrospinal Fluid (CSF) Amyloid Beta During Sleep Induction and Sleep Deprivation Between 01:00 and 11:00 From Baseline
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) through modulation of the sleep-wake cycle.
详细描述
The purpose of this research study is to investigate whether or not increasing or decreasing duration of sleep over one night will change the concentration of amyloid-beta in cerebral spinal 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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •cognitively normal or CDR 0
- •negative for amyloid deposition by PET Pittsburgh Compound-B (PIB) imaging or CSF amyloid-beta-42 concentration
- •Age 18-60
- •Average reported sleep time 6-10hrs
排除标准
- •diagnosis of a sleep disorder such as sleep apnea, narcolepsy, or restless leg syndrome
- •positive ambulatory sleep study for obstructive sleep apnea (AHI > 5 respiratory events per hour) that will be performed as part of initial screening prior to enrollment
- •Clinical Dementia Rating (CDR) > 0
- •tremor or other neurologic injury in the non-dominant upper extremity (such as stroke or tremor) that would prevent the use of actigraphy
- •current sleep walking or other sleep parasomnia
- •diagnosis and treatment of stroke, myocardial infarction or heart attack,
- •coronary artery disease, atrial fibrillation, or congestive heart failure
- •diagnosis and treatment of asthma or Chronic Obstructive Pulmonary Disease (COPD)
- •diagnosis and treatment of bipolar disorder, major depression, or Schizophrenia
- •current urinary or fecal incontinence
- •currently on a low salt diet
- •diagnosis and treatment of a neurologic disorder such as Parkinson's disease, epilepsy, multiple sclerosis
- •currently taking any blood thinner medications such as warfarin, Plavix, or Aspirin
- •kidney disease resulting in renal impairment
- •liver disease resulting in hepatic dysfunction
- •Pregnancy
- •currently taking sedating medications such as benzodiazepines
- •alcohol use at bedtime
- •tobacco use
- •contraindication to lumbar puncture
- •sleep schedule outside the range of bedtime: 8pm-12am and waketime 4am-8am
- •self reported difficulty sleeping in an unfamiliar environment
- •use of sedative-hypnotic medications
- •inability to get in and out of bed
- •history or presence of any clinically significant medical condition, behavioral or psychiatric disorder, or surgical history based on medical record or patient report
- •history of drug abuse within the past 6 months
- •positive score on 2 or more categories on the Berlin questionnaire
- •participation in another investigational medicinal product or investigational device within the last 30 days
研究组 & 干预措施
Sleep Induction
7.5 grams of sodium oxybate
干预措施: Sodium Oxybate (Drug)
Sleep Deprivation
Sleep deprivation for up to 36 hours with no naps or other sleep periods
干预措施: Sleep deprivation (Behavioral)
结局指标
主要结局
Percent Increase From Mean Baseline (07:00 to 19:00) of Cerebrospinal Fluid (CSF) Amyloid Beta During Sleep Induction and Sleep Deprivation Between 01:00 and 11:00 From Baseline
时间窗: Baseline = 07:00 to 19:00; Intervention period = 01:00 to 11:00
Overnight (01:00 to 11:00) differences in CSF amyloid beta from baseline (07:00 to 19:00) between 1) sleep-deprived and control participants and 2) sleep-induced and control participants.
次要结局
未报告次要终点