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Completed

NCT Number: NCT03077620

Sleep Quality and Amyloid-Beta Kinetics

The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) by modification of sleep efficiency.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63144, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suvorexant

Drug

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

Drug

Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.

Other names: sugar pill

Primary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 13, 2017
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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