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OpenTrials
Completed

NCT Number: NCT05547880

CNS Correlates of Extended Sleep Restriction

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.

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Key information

Conditions

Sleep Restriction Inflammation Nervous System Diseases Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Ages 18 to 39 (inclusive)
  • A body mass index (BMI) below 30.
  • Weigh at least 140 lbs
  • 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.

Treatment and study plan

[11C]ER176

Drug

Brain PET with [11C]ER176. [11C]ER176 is a PET ligand that images TSPO.

Primary outcomes

  1. Positron Emission Tomography (PET) based measurement of neuroinflammation

    Time frame: 3 Days

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

Secondary outcomes

  1. Psychomotor Vigilance Task (PVT)

    Time frame: 55 Days

    Measure of cognitive performance

  2. Actigraphy

    Time frame: 55 Days

    Activity monitoring used to infer sleep-wake patterns

  3. Polysomnographic measurements of sleep and wakefulness

    Time frame: 19 Days

    Measure of various aspects of sleep and wakefulness

Sponsors and collaborators

Lead sponsor

Walter Reed Army Institute of Research (WRAIR)

Fed

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Intrepid Center of Excellence

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2022
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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