CNS Correlates of Extended Sleep Restriction

August 12, 2023 updated by: Samantha Riedy, Walter Reed Army Institute of Research (WRAIR)
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychomotor Vigilance Task (PVT)
Time Frame: 55 Days
Measure of cognitive performance
55 Days
Actigraphy
Time Frame: 55 Days
Activity monitoring used to infer sleep-wake patterns
55 Days
Polysomnographic measurements of sleep and wakefulness
Time Frame: 19 Days
Measure of various aspects of sleep and wakefulness
19 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Reed Army Institute of Research (WRAIR)

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

July 26, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 12, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2804
  • MO220146 (Other Grant/Funding Number: Military Operational Medicine Research Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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