Sleep Quality and Amyloid-Beta Kinetics
Primary Purpose
Amyloid-beta
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suvorexant
Placebo
Sponsored by
About this trial
This is an interventional other trial for Amyloid-beta
Eligibility 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-9AM
- 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 judgment of the PI is not a good candidate
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Experimental
Arm Label
Poor sleep group treatment 1
Poor sleep group control
Good sleep group
Poor sleep group treatment 2
Arm Description
10mg Suvorexant tablet h.s. for two consecutive nights
Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.
Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.
20mg Suvorexant tablet h.s. for two consecutive nights
Outcomes
Primary Outcome Measures
Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Compared to Those With Good Sleep Efficiency as Measured by ng/ml
Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency (Poor sleep group control) compared to those with good sleep efficiency (Good sleep group)
Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Treated With Placebo, Suvorexant 10 mg, or Suvorexant 20 mg as Measured by ng/ml
Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency who were treated with placebo (Poor sleep group control), Suvorexant 10 mg (Poor sleep group treatment 1), and Suvorexant 20 mg (Poor sleep group treatment 2)
Secondary Outcome Measures
Full Information
NCT ID
NCT03077620
First Posted
October 17, 2016
Last Updated
May 16, 2022
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03077620
Brief Title
Sleep Quality and Amyloid-Beta Kinetics
Official Title
Sleep Quality and Amyloid-Beta Kinetics
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 28, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloid-beta
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Poor sleep group treatment 1
Arm Type
Experimental
Arm Description
10mg Suvorexant tablet h.s. for two consecutive nights
Arm Title
Poor sleep group control
Arm Type
Placebo Comparator
Arm Description
Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.
Arm Title
Good sleep group
Arm Type
Placebo Comparator
Arm Description
Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.
Arm Title
Poor sleep group treatment 2
Arm Type
Experimental
Arm Description
20mg Suvorexant tablet h.s. for two consecutive nights
Intervention Type
Drug
Intervention Name(s)
Suvorexant
Other Intervention Name(s)
Belsomra
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.
Primary Outcome Measure Information:
Title
Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Compared to Those With Good Sleep Efficiency as Measured by ng/ml
Description
Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency (Poor sleep group control) compared to those with good sleep efficiency (Good sleep group)
Time Frame
36 hours of CSF collection
Title
Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Treated With Placebo, Suvorexant 10 mg, or Suvorexant 20 mg as Measured by ng/ml
Description
Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency who were treated with placebo (Poor sleep group control), Suvorexant 10 mg (Poor sleep group treatment 1), and Suvorexant 20 mg (Poor sleep group treatment 2)
Time Frame
36 hours of CSF collection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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-9AM
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 judgment of the PI is not a good candidate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brendan Lucey, MD
Organizational Affiliation
Washington University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63144
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Sleep Quality and Amyloid-Beta Kinetics
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