ClinicalTrials.gg
CompletedNCT05547880Updated May 18, 2025

CNS Correlates of Extended Sleep Restriction

An observational study in Sleep Restriction, sponsored by Walter Reed Army Institute of Research (WRAIR). Completed at 1 site in United States. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-18.

Sponsored by Walter Reed Army Institute of Research (WRAIR) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
13
Ages
18 Years to 39 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sleep Restriction

Keywords

  • Sleep Restriction
  • Alertness
  • Performance
  • Neuroinflammation
  • Biomarker
03

In context

Neuroinflammatory Diseases

180 studies on the registry are indexed under Neuroinflammatory Diseases; 80 are open to participants now.

This study's enrollment of 13 is below the median of 88 across 64 observational studies indexed under Neuroinflammatory Diseases.

Browse Neuroinflammatory Diseases studies →

Lead sponsor

Walter Reed Army Institute of Research (WRAIR) is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Community sample

Eligibility criteria

  • Ages 18 to 39 (inclusive)
  • A (BMI) below 30.
  • Weigh at least 140 lbs
  • Females must not be pregnant or nursing, and must be on some form of , 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
13 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

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

06

What researchers measure

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

    Time frame: 3 Days

Secondary outcomes

  1. Psychomotor Vigilance Task (PVT)

    Measure of cognitive performance

    Time frame: 55 Days

  2. Actigraphy

    Activity monitoring used to infer sleep-wake patterns

    Time frame: 55 Days

  3. Polysomnographic measurements of sleep and wakefulness

    Measure of various aspects of sleep and wakefulness

    Time frame: 19 Days

07

Study locations

1 site
  • Walter Reed Army Institute of Research
    Silver Spring, Maryland 20910, United States
08

References and documents

Publications

  • 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. PubMed 12603781 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05547880
Lead sponsor
Walter Reed Army Institute of Research (WRAIR)
Collaborators
National Institute of Mental Health (NIMH), National Intrepid Center of Excellence
Responsible party
Samantha Riedy (Principal Investigator, Walter Reed Army Institute of Research (WRAIR)) — Principal investigator
First posted
Sep 21, 2022
Start date
May 23, 2023
Primary completion
Mar 15, 2025
Completion
Mar 15, 2025
Last update
May 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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