Sleep Quality and Amyloid-Beta Kinetics

Amyloid-beta Clinical Trial

Official title:

Sleep Quality and Amyloid-Beta Kinetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077620
• Other study ID #: 201602165
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: March 30, 2021

Study information

• Verified date: May 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 30, 2021
• Est. primary completion date: March 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyloid-beta
• Amyloidosis

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	36 hours of CSF collection
Primary	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)	36 hours of CSF collection