Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
Not Applicable
Completed
- Conditions
- Amyloid-beta
- Interventions
- Behavioral: Sleep deprivation
- Registration Number
- NCT02063217
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- BMI >40
- contraindication to lumbar puncture
- diabetes
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleep Deprivation Sleep deprivation Sleep deprivation for up to 36 hours with no naps or other sleep periods Sleep Induction Sodium Oxybate 7.5 grams of sodium oxybate
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Washington University Medical School
🇺🇸Saint Louis, Missouri, United States