Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sleep Quality and Amyloid-Beta Kinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03077620
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE October 17, 2016
First Posted Date  ICMJE March 13, 2017
Last Update Posted Date February 11, 2020
Actual Study Start Date  ICMJE November 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
Change in Amyloid-beta (Abeta) production, clearance, and concentration in the CSF (cerebral spinal fluid) of individuals with poor sleep efficiency as measured by ng/ml. [ Time Frame: 36 hours of CSF collection ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
Change in Amyloid-beta (Abeta) production, clearance, and concentrations in the CSF (cerebral spinal fluid) following pharmacologic sleep induction.induction in individuals with poor sleep efficiency. [ Time Frame: 36 hours of CSF collection ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Quality and Amyloid-Beta Kinetics
Official Title  ICMJE Sleep Quality and Amyloid-Beta Kinetics
Brief Summary The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) by modification of sleep efficiency.
Detailed Description The purpose of the study is to investigate whether or not increasing sleep efficiency will change the concentration of amyloid-beta in cerebrospinal fluid (CSF).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Amyloid-beta
Intervention  ICMJE
  • Drug: Suvorexant
    Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.
    Other Name: Belsomra
  • Drug: Placebo
    Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.
    Other Name: sugar pill
Study Arms  ICMJE
  • Experimental: Poor sleep group treatment 1
    10mg Suvorexant tablet h.s. for two consecutive nights
    Intervention: Drug: Suvorexant
  • Placebo Comparator: Poor sleep group control
    Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.
    Intervention: Drug: Placebo
  • Placebo Comparator: Good sleep group
    Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.
    Intervention: Drug: Placebo
  • Experimental: Poor sleep group treatment 2
    20mg Suvorexant tablet h.s. for two consecutive nights
    Intervention: Drug: Suvorexant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2017)
45
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 45-65 years
  • Any sex
  • Any race/ethnicity
  • Mini-Mental Status Examination score (MMSE) >=27
  • Sleep efficiency measured by actigraphy to determine good sleeper or poor sleeper

Exclusion Criteria:

  • Cognitive impairment as determined by history of MMSE < 27
  • Inability to speak or understand English
  • BMI >35
  • Any sleep disorders other than insomnia
  • history of sleep-disordered breathing
  • STOP-Bang score > 3
  • History or reported symptoms suggestive of restless legs syndrome, narcolepsy or other sleep disorders
  • Sleep schedule outside the range of bedtime 8PM-12AM and wake time 4AM-8AM
  • Contraindication to lumbar catheter (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery)
  • Cardiovascular disease requiring medication except for controlled hypertension (PI discretion)
  • Stroke
  • Hepatic or renal impairment
  • Pulmonary disease (PI discretion)
  • Type 1 diabetes
  • HIV or AIDS
  • Neurologic or psychiatric disorder requiring medication (PI discretion)
  • Alcohol or tobacco use (PI discretion)
  • Use of sedating medications
  • Inability to get out of bed independently
  • Abnormal movement of the non-dominant arm (would affect actigraphy data in unpredictable ways)
  • Abnormal physical examination
  • Current pregnancy
  • History of migraine headaches (PI discretion)
  • History of drug abuse in the past 6 months
  • Urinary or fecal incontinence
  • Difficulty sleeping in an unfamiliar environment (good sleep quality group only)
  • History or presence of any clinically significant medication condition, behavioral or psychiatric condition (including suicidal ideation), or surgical history based on medical record or patient report that could affect the safety of the subject or interfere with study assessments or in the judgement of the PI is not a good candidate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Cristina Toedebusch, BS 314-747-0646 toedebuschc@wustl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03077620
Other Study ID Numbers  ICMJE 201602165
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brendan Lucey, MD Washington University Medical School
PRS Account Washington University School of Medicine
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP