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Insufficient Sleep for Circadian Dysregulation

N/A
Waitlist Available
Led By Kenneth Wright, PhD
Research Sponsored by University of Colorado, Boulder
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed ~every 6 hours while living in the laboratory (10 times per visit, 2 laboratory visits as part of a 39 day protocol)
Awards & highlights

Summary

This study is about how sleep loss and being awake at night impacts the ability to think, changes molecules in the blood, and alters the bacteria that live in the gut that typically help keep people healthy. This work will have important implications for the development of treatments and countermeasures for people who do not sleep enough and need to be active at different times of the day and night (e.g., emergency workers and military personnel).

Eligible Conditions
  • Stress
  • Circadian Dysregulation
  • Sleep Deprivation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed ~every 6 hours while living in the laboratory (10 times per visit, 2 laboratory visits as part of a 39 day protocol)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed ~every 6 hours while living in the laboratory (10 times per visit, 2 laboratory visits as part of a 39 day protocol) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Weight Changes
Change in fecal microbiome
Secondary study objectives
Changes in plasma metabolome
Karolinska Sleepiness Scale
Maintenance of wakefulness test
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Insufficient SleepExperimental Treatment1 Intervention
3 days with 3 hour sleep opportunities in lab, immediately following baseline on both visit 1 and visit 2.
Group II: BaselineActive Control1 Intervention
8 hour sleep opportunity at habitual sleep/wake times for 14 days at home and 1 day in lab. Repeated for visit 1 and visit 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insufficient Sleep
2017
N/A
~20

Find a Location

Who is running the clinical trial?

Office of Naval Research (ONR)FED
14 Previous Clinical Trials
605 Total Patients Enrolled
University of Colorado, BoulderLead Sponsor
122 Previous Clinical Trials
29,109 Total Patients Enrolled
University of California, San DiegoOTHER
1,157 Previous Clinical Trials
1,571,369 Total Patients Enrolled
~5 spots leftby Sep 2025
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