Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction

Amyloid-beta Clinical Trial

Official title:

Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063217
• Other study ID #: 201304030
• Secondary ID: P50AG005681-30
• Status: Completed
• Phase: N/A
• First received: January 29, 2014
• Last updated: March 26, 2018
• Start date: December 2013
• Est. completion date: July 2016

Study information

• Verified date: March 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyloid-beta
• Amyloidosis
• Sleep Deprivation

Intervention

Drug:
• Sodium Oxybate
Sodium oxybate h.s.

Behavioral:
• Sleep deprivation
36hr sleep deprivation

Locations

Country	Name	City	State
United States	Washington University Medical School	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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.	Baseline = 07:00 to 19:00; Intervention period = 01:00 to 11:00