Sleep Quality and Amyloid-Beta Kinetics

NCT ID: NCT03077620

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2021-03-30

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).

Conditions

Amyloid-beta

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Poor sleep group treatment 1

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

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Poor sleep group treatment 2

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

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Belsomra; sugar pill

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brendan Lucey, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University Medical School

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201602165

Identifier Type: -

Identifier Source: org_study_id