Clinical trial NCT03077620: Sleep Quality and Amyloid-Beta Kinetics
Official title: Sleep Quality and Amyloid-Beta Kinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyloid-beta
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 48
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: 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
timeFrame: 36 hours of CSF collection
measure: 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
timeFrame: 36 hours of CSF collection
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University Medical School
name: Brendan Lucey, MD
role: PRINCIPAL_INVESTIGATOR
References: