Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
Overview
- Phase
- Not Applicable
- Intervention
- Sodium Oxybate
- Conditions
- Amyloid-beta
- Sponsor
- Washington University School of Medicine
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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).
Investigators
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
Arms & Interventions
Sleep Induction
7.5 grams of sodium oxybate
Intervention: Sodium Oxybate
Sleep Deprivation
Sleep deprivation for up to 36 hours with no naps or other sleep periods
Intervention: Sleep deprivation
Outcomes
Primary Outcomes
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
Time Frame: 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.