NCT03747367

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2017

Completed
1 year until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

5.5 years

First QC Date

November 14, 2017

Last Update Submit

October 29, 2020

Conditions

Sleep DeprivationCircadian DysregulationStress

Keywords

MicrobiomeStressSleepCircadian

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (4)

  • Visual Search Performance

    Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol)

  • Maintenance of wakefulness test

    Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol)

  • Karolinska Sleepiness Scale

    Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol)

  • Changes in plasma metabolome

    Assessed ~every 6 hours while living in the laboratory (10 times per visit, 2 laboratory visits as part of a 39 day protocol)

Study Arms (2)

Baseline

NO 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.

Insufficient Sleep

EXPERIMENTAL

3 days with 3 hour sleep opportunities in lab, immediately following baseline on both visit 1 and visit 2.

Behavioral: Insufficient Sleep

Interventions

Insufficient SleepBEHAVIORAL
Insufficient Sleep

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Currently residing at Denver altitude or higher

You may not qualify if:

  • Current major medical disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep and Chronobiology Laboratory

Boulder, Colorado, 80309-0554, United States

RECRUITING

MeSH Terms

Conditions

Sleep DeprivationChronobiology Disorders

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Kenneth Wright, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sleep and Chronobiology Laboratory

CONTACT

303 735 1923sleep.study@colorado.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Experiment 1 - none Experiment 2 - double-blind
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Experiment 1 - Single group, repeated assessment Experiment 2 - Double-blind, randomized, cross-over design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 20, 2018

Study Start

October 21, 2015

Primary Completion

May 1, 2021

Study Completion

September 1, 2021

Last Updated

October 30, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

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

Locations

US(1)