CClinicalTrials.gg
Sign In
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

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 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.
04

Study design

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

Interventions

  • Drug[11C]ER176

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

05

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

06

Study locations

1 site
  • Walter Reed Army Institute of Research
    Silver Spring, Maryland 20910, United States
07

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

  • Informed consent form · Apr 16, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Walter Reed Army Institute of Research (WRAIR)

Start the discussion