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The Microbiome and Resilience to Sleep and Circadian Disruption

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
No Placebo-Only Group

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
  • Sleep disorder
  • Sleep Deprivation
  • Stress

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
124 Previous Clinical Trials
29,371 Total Patients Enrolled
3 Trials studying Sleep Deprivation
146 Patients Enrolled for Sleep Deprivation
University of California, San DiegoOTHER
1,189 Previous Clinical Trials
1,587,658 Total Patients Enrolled
3 Trials studying Sleep Deprivation
169 Patients Enrolled for Sleep Deprivation
Kenneth Wright, PhDPrincipal Investigator - University of Colorado, Denver
University of Colorado, Boulder
1 Previous Clinical Trials
66 Total Patients Enrolled
~5 spots leftby Dec 2025
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