Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Microbiome and Resilience to Sleep and Circadian Disruption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03747367
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborators:
University of California, San Diego
Office of Naval Research (ONR)
Information provided by (Responsible Party):
Kenneth Wright, University of Colorado, Boulder

Brief 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).

Condition or disease Intervention/treatment Phase
Sleep Deprivation Circadian Dysregulation Stress Behavioral: Insufficient Sleep Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Experiment 1 - Single group, repeated assessment Experiment 2 - Double-blind, randomized, cross-over design
Masking: Double (Participant, Investigator)
Masking Description: Experiment 1 - none Experiment 2 - double-blind
Primary Purpose: Basic Science
Official Title: The Microbiome and Responsiveness to Stress: Countermeasure Strategies for Improving Resilience to Sleep and Circadian Disruption (Experiments 1 & 2)
Actual Study Start Date : October 21, 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
No Intervention: Baseline
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.
Experimental: Insufficient Sleep
3 days with 3 hour sleep opportunities in lab, immediately following baseline on both visit 1 and visit 2.
Behavioral: Insufficient Sleep



Primary Outcome Measures :
  1. Change in fecal microbiome [ Time Frame: Daily fecal samples while living in laboratory (3 samples per visit, 2 laboratory visits as part of a 39 day protocol) ]
    Fecal "beta diversity" (unit=weighted UniFrac)

  2. Change in fecal metabolome [ Time Frame: Daily fecal samples while living in laboratory (3 samples per visit, 2 laboratory visits as part of a 39 day protocol) ]
    Fecal small molecules (Mass spect metabolite abundance)


Secondary Outcome Measures :
  1. Visual Search Performance [ Time Frame: Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol) ]
    Cognitive Throughput (items/minute)

  2. Maintenance of wakefulness test [ Time Frame: Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol) ]
    Average latency to falling asleep (minutes)

  3. Karolinska Sleepiness Scale [ Time Frame: Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol) ]
    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.

  4. Changes in plasma metabolome [ Time Frame: Assessed ~every 6 hours while living in the laboratory (10 times per visit, 2 laboratory visits as part of a 39 day protocol) ]
    Plasma small molecules (Mass spect metabolite abundance)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Currently residing at Denver altitude or higher

Exclusion Criteria:

  • Current major medical disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747367


Contacts
Layout table for location contacts
Contact: Sleep and Chronobiology Laboratory 303 735 1923 sleep.study@colorado.edu

Locations
Layout table for location information
United States, Colorado
Sleep and Chronobiology Laboratory Recruiting
Boulder, Colorado, United States, 80309-0554
Sponsors and Collaborators
University of Colorado, Boulder
University of California, San Diego
Office of Naval Research (ONR)
Investigators
Layout table for investigator information
Principal Investigator: Kenneth Wright, PhD University of Colorado, Denver

Layout table for additonal information
Responsible Party: Kenneth Wright, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT03747367     History of Changes
Other Study ID Numbers: 15-0282
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Any data generated from the proposed work that is presented in a peer reviewed journal will be de-identified.

Microbiome data will be deposited in the International Nucleotide Sequence Database Collaboration www.insdc.org/ and is already deposited in Qiita http://qiita.microbio.me

Metabolomics data will be deposited in Global Natural Products Social (GNPS) molecular networking http://gnps.ucsd.edu

Other data that is presented in a peer reviewed journal will be archived indefinitely and made available upon request.

Time Frame: Upon publication, microbiome data to be deposited permanently in International Nucleotide Sequence Database Collaboration www.insdc.org/ Data already deposited in Qiita http://qiita.microbio.me Upon publication, metabolomics data to be deposited permanently in Global Natural Products Social (GNPS) molecular networking http://gnps.ucsd.edu
Access Criteria: data will be freely available at www.insdc.org/ and http://gnps.ucsd.edu

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kenneth Wright, University of Colorado, Boulder:
Microbiome
Stress
Sleep
Circadian

Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Deprivation
Chronobiology Disorders
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders