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.
Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
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.
Intervention / Treatment
-
Sodium Oxybate (DRUG)Sodium oxybate h.s.
-
Sleep deprivation (BEHAVIORAL)36hr sleep deprivation
Condition or Disease
- Amyloid-beta
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 60 Years |
| Enrollment: | 36 (ACTUAL) |
| Funded by: | Other|NIH |
| Allocation: | Randomized |
| Primary Purpose: | Other |
MaskingSINGLE:
|
|
Clinical Trial Dates
| Start date: | Dec 01, 2013 | |
|---|---|---|
| Primary Completion: | Jul 01, 2016 | ACTUAL |
| Completion Date: | Jul 01, 2016 | ACTUAL |
| Study First Posted: | Feb 14, 2014 | ESTIMATED |
| Results First Posted: | Apr 26, 2018 | ACTUAL |
| Last Updated: | Mar 26, 2018 |
Sponsors / Collaborators
Lead Sponsor:
Washington University School of Medicine
Lead sponsor is responsible party
Responsible Party:
N/A
Location
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).
Participant Groups
-
7.5 grams of sodium oxybate
-
Sleep deprivation for up to 36 hours with no naps or other sleep periods
-
Participant will sleep as normal under the same controlled conditions in a clinical research unit
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 60 |
| Age Groups: | Adult |
| Healthy Volunteers: | Yes |
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
* 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
More Details
| NCT Number: | NCT02063217 |
|---|---|
| Other IDs: | 201304030 |
| Study URL: | https://clinicaltrials.gov/study/NCT02063217 |
Last updated: Sep 29, 2023