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Sleep Quality and Amyloid-Beta Kinetics

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ClinicalTrials.gov Identifier: NCT03077620
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Amyloid-beta Drug: Suvorexant Drug: Placebo Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Sleep Quality and Amyloid-Beta Kinetics
Actual Study Start Date : November 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis
Drug Information available for: Suvorexant

Arm Intervention/treatment
Experimental: Poor sleep group treatment 1
10mg Suvorexant tablet h.s. for two consecutive nights
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

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.
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

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.
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

Experimental: Poor sleep group treatment 2
20mg Suvorexant tablet h.s. for two consecutive nights
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077620


Contacts
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Contact: Cristina Toedebusch, BS 314-747-0646 toedebuschc@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63144
Contact: Cristina Toedebusch, BS    314-747-0646    toedebuschc@neuro.wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Brendan Lucey, MD Washington University Medical School

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03077620     History of Changes
Other Study ID Numbers: 201602165
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Suvorexant
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action