CNS Correlates of Extended Sleep Restriction

NCT05547880 | Completed FDA Drug

• 2 other identifiers: 2804MO220146
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Restriction

Keywords

Sleep Restriction; Alertness; Performance; Neuroinflammation; Biomarker

Outcome Measures

Primary Outcomes (1)

• Positron Emission Tomography (PET) based measurement of neuroinflammation

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

  3 Days

Secondary Outcomes (3)

• Psychomotor Vigilance Task (PVT)

  55 Days

• Actigraphy

  55 Days

• Polysomnographic measurements of sleep and wakefulness

  19 Days

Interventions

[11C]ER176 DRUG

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

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Walter Reed Army Institute of Research (WRAIR): lead
• National Institute of Mental Health (NIMH): collaborator
• National Intrepid Center of Excellence: collaborator

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

Related Publications (1)

• Belenky G, Wesensten NJ, Thorne DR, Thomas ML, Sing HC, Redmond DP, Russo MB, Balkin TJ. Patterns of performance degradation and restoration during sleep restriction and subsequent recovery: a sleep dose-response study. J Sleep Res. 2003 Mar;12(1):1-12. doi: 10.1046/j.1365-2869.2003.00337.x.

  PMID: 12603781 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma

MeSH Terms

Conditions

Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: September 21, 2022
• Study Start: May 23, 2023
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)