Clinical trial NCT02063217: Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
Official title: Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyloid-beta
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2014-02-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: 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
timeFrame: Baseline = 07:00 to 19:00; Intervention period = 01:00 to 11:00
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
Study officials:
affiliation: Washington University Medical School
name: Brendan Lucey, MD
role: PRINCIPAL_INVESTIGATOR
References: