Sleep Quality and Amyloid-Beta Kinetics

May 16, 2022 updated by: Washington University School of Medicine
The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) by modification of sleep efficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63144
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Belsomra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 36 hours of CSF collection
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)
36 hours of CSF collection
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
Time Frame: 36 hours of CSF collection
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)
36 hours of CSF collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Brendan Lucey, MD, Washington University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

March 28, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201602165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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