CNS Correlates of Extended Sleep Restriction

Sleep Restriction Clinical Trial

Official title:

CNS Correlates of Extended Sleep Restriction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547880
• Other study ID #: 2804
• Secondary ID: MO220146
• Status: Recruiting
• Start date: May 23, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: Walter Reed Army Institute of Research (WRAIR)
• Contact: Samantha M Riedy, PhD
• Phone: 301-319-3944
• Email: samantha.m.riedy.ctr[@]health.mil
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Sleep Restriction

Intervention

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

Locations

Country	Name	City	State
United States	Walter Reed Army Institute of Research	Silver Spring	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Walter Reed Army Institute of Research (WRAIR)	National Institute of Mental Health (NIMH), National Intrepid Center of Excellence

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Psychomotor Vigilance Task (PVT)	Measure of cognitive performance	55 Days
Secondary	Actigraphy	Activity monitoring used to infer sleep-wake patterns	55 Days
Secondary	Polysomnographic measurements of sleep and wakefulness	Measure of various aspects of sleep and wakefulness	19 Days