CNS Correlates of Extended Sleep Restriction

Sponsor

Walter Reed Army Institute of Research (WRAIR) (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT05547880

Collaborator

National Institute of Mental Health (NIMH) (NIH), National Intrepid Center of Excellence (U.S. Fed)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Chronic sleep restriction is ubiquitous in both the general population and the military. The deleterious effects of sleep loss on human alertness and cognitive performance have been documented in numerous studies dating back to the nineteenth century. Over the past decade, evidence has emerged indicating that chronic sleep restriction may also precipitate deleterious, long lasting neuropathological changes in the brain. The purpose of this study is to determine neuropathological effects of sleep restriction and identify physiological mechanisms that correlate with sleep loss-induced performance impairment.

Condition or Disease	Intervention/Treatment	Phase
Sleep Restriction	Drug: [11C]ER176

Study Design

Study Type:

Observational

Anticipated Enrollment :

18 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

CNS Correlates of Extended Sleep Restriction

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Outcome Measures

Primary Outcome Measures

Positron Emission Tomography (PET) based measurement of neuroinflammation [3 Days]
Positron Emission Tomography (PET) is the brain imaging method and [11C]ER176 is the PET radioligand providing an index of neuroinflammation

Secondary Outcome Measures

Psychomotor Vigilance Task (PVT) [55 Days]
Measure of cognitive performance
Actigraphy [55 Days]
Activity monitoring used to infer sleep-wake patterns
Polysomnographic measurements of sleep and wakefulness [19 Days]
Measure of various aspects of sleep and wakefulness

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Ages 18 to 39 (inclusive)
Weigh at least 140 lbs
A body mass index (BMI) below 30.
Learned English by the age of 2
Females must not be pregnant or nursing, and must be on some form of birth control, if sexually active (e.g., oral contraceptive, condom, intrauterine device, etc.)
No history of sleeping problems such as insomnia or sleep apnea.
Test negative for alcohol, nicotine, illegal drugs, and not take certain medications.
Must not excessively consume alcohol or caffeine.
Active duty and Federal employees must be on leave during participation.
No history of heart disease (high blood pressure), neurologic disorder (such as seizures of epilepsy), liver disease, kidney disease, or metabolic disorder or diabetes.
No history of underlying acute or chronic pulmonary disease requiring daily inhaler use.