N/A
N=36
Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
Amyloid-beta
Bottom Line
View on ClinicalTrials.gov: NCT02063217 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: 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 — 113; 123; 106 percent increase from mean baseline — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sodium Oxybate (Drug); Sleep deprivation (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
113; 123; 106 | 0.07 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02063217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.