CNS Correlates of Extended Sleep Restriction

NCT ID: NCT05547880

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-23

Study Completion Date

2025-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Restriction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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[11C]ER176

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

National Intrepid Center of Excellence

FED

Sponsor Role collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role lead

Responsible Party

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Samantha Riedy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Walter Reed Army Institute of Research

Silver Spring, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12603781 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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MO220146

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2804

Identifier Type: -

Identifier Source: org_study_id

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