Sleep Quality and Amyloid-Beta Kinetics

The Washington University

Status: Completed

Conditions: Amyloid-beta

Treatments: Drug: Placebo; Drug: Suvorexant

Study type: Interventional

Funder types: Other

Identifiers

NCT03077620

201602165

Details and patient eligibility

About

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

Full 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).

Enrollment: 48 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 4 patient groups, including a placebo group

Poor sleep group treatment 1

Experimental group

Description:

10mg Suvorexant tablet h.s. for two consecutive nights

Treatment:

Drug: Suvorexant

Poor sleep group control

Placebo Comparator group

Description:

Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.

Treatment:

Drug: Placebo

Good sleep group

Placebo Comparator group

Description:

Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.

Treatment:

Drug: Placebo

Poor sleep group treatment 2

Experimental group

Description:

20mg Suvorexant tablet h.s. for two consecutive nights

Treatment:

Drug: Suvorexant