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CNS Correlates of Extended Sleep Restriction

CNS Correlates of Extended Sleep Restriction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05547880
Enrollment
13
Registered
2022-09-21
Start date
2023-05-23
Completion date
2025-03-15
Last updated
2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Restriction

Keywords

Sleep Restriction, Alertness, Performance, Neuroinflammation, Biomarker

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.

Interventions

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
National Intrepid Center of Excellence
CollaboratorFED
Walter Reed Army Institute of Research (WRAIR)
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Positron Emission Tomography (PET) based measurement of neuroinflammation3 DaysPositron Emission Tomography (PET) is the brain imaging method and \[11C\]ER176 is the PET radioligand providing an index of neuroinflammation

Secondary

MeasureTime frameDescription
Psychomotor Vigilance Task (PVT)55 DaysMeasure of cognitive performance
Actigraphy55 DaysActivity monitoring used to infer sleep-wake patterns
Polysomnographic measurements of sleep and wakefulness19 DaysMeasure of various aspects of sleep and wakefulness

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026