Stress Clinical Trial
Official title:
The Microbiome and Responsiveness to Stress: Countermeasure Strategies for Improving Resilience to Sleep and Circadian Disruption (Experiments 1 & 2)
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).
Status | Recruiting |
Enrollment | 50 |
Est. completion date | September 2021 |
Est. primary completion date | May 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - Healthy - Currently residing at Denver altitude or higher Exclusion Criteria: - Current major medical disorder |
Country | Name | City | State |
---|---|---|---|
United States | Sleep and Chronobiology Laboratory | Boulder | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Boulder | Office of Naval Research (ONR), University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in fecal microbiome | Fecal "beta diversity" (unit=weighted UniFrac) | Daily fecal samples while living in laboratory (3 samples per visit, 2 laboratory visits as part of a 39 day protocol) | |
Primary | Change in fecal metabolome | Fecal small molecules (Mass spect metabolite abundance) | Daily fecal samples while living in laboratory (3 samples per visit, 2 laboratory visits as part of a 39 day protocol) | |
Secondary | Visual Search Performance | Cognitive Throughput (items/minute) | Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol) | |
Secondary | Maintenance of wakefulness test | Average latency to falling asleep (minutes) | Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol) | |
Secondary | Karolinska Sleepiness Scale | Single question likert scale: Total score reported with a range of 1-9; min score=1[very alert], maximum score=9[very sleepy, great effort to keep awake, fighting sleep]. A higher score representing higher sleepiness. A lower score represents less sleepiness and a better outcome. | Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol) | |
Secondary | Changes in plasma metabolome | Plasma small molecules (Mass spect metabolite abundance) | Assessed ~every 6 hours while living in the laboratory (10 times per visit, 2 laboratory visits as part of a 39 day protocol) |
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