Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
Status: | Completed |
---|---|
Conditions: | Insomnia Sleep Studies, Hematology |
Therapuetic Areas: | Hematology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 4/28/2018 |
Start Date: | December 2013 |
End Date: | July 2016 |
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.
cerebrospinal fluid (CSF) through modulation of the sleep-wake cycle.
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).
duration of sleep over one night will change the concentration of amyloid-beta in cerebral
spinal fluid (CSF).
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
We found this trial at
1
site
Saint Louis, Missouri 63110
Principal Investigator: Brendan Lucey, MD
Phone: 314-747-3819
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