Sleep DeprivationNCT03130803
Biomarkers of Insufficient Sleep and Sleepiness
A study testing Insufficient Sleep in people with Sleep Deprivation and Insufficient Sleep Syndrome, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
Sleep and wakefulness disorders impact 50 to 70 million Americans and insufficient sleep is epidemic with over 50% of Americans reporting less than 7 hours of sleep per night. Health problems associated with insufficient sleep include inflammation, depression and anxiety, diabetes, stress, drug abuse, poor quality of… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Insufficient Sleep Syndrome, Sleep Wake Disorders
- What is being tested?
- Insufficient Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2017to 22 Feb 2019
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal Body mass index (18.5-24.9)
- normal blood chemistries
- habitual sleep duration ~7 - 9.25 hours
- live at Denver altitude or higher for at least 3 months
Who cannot join
- must not be participating in another research study that could influence safe participation in the current study
- any clinically significant medical or surgical condition within last year
- clinically significant abnormality during physical examination
- any physician determined significant abnormality in vital signs, EKG, or clinical laboratory values
- any clinically significant psychiatric condition defined by DSM-V
- any clinically significant sleep disorder
Show all 15Show fewer
- use of medications/supplements/drugs within one month of study or need of medications during study
- symptoms of active illness
- uncorrected visual impairment
- working shift-work in year prior to study
- travel more than 1 time zone in 3 weeks prior to study
- pregnant/nursing
- greater than moderate caffeine or alcohol use
- positive toxicology screening
- current smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep and Chronobiology Laboratory
Boulder, Colorado, 80309
About this study
Sleep and wakefulness disorders impact 50 to 70 million Americans and insufficient sleep is epidemic with over 50% of Americans reporting less than 7 hours of sleep per night. Health problems associated with insufficient sleep include inflammation, depression and anxiety, diabetes, stress, drug abuse, poor quality of life, obesity, and fatigue related accidents on the job/while driving. While the contribution of sleep to overall health, well-being, and public safety is recognized, no established clinical biomarkers of sleep deficiency exist. Such biomarkers would have utility as road-side biomarkers of sleepiness (e.g., drowsy driving), monitoring on the job fatigue/fitness for duty (e.g., transportation, military ops health care), monitoring sleep health, as well as for clinical diagnostics and measures of clinical treatment outcomes. Thus, investigators designed a controlled laboratory insufficient sleep protocol utilizing metabolomics to identify biomarkers of insufficient sleep. Investigators propose to identify changes in metabolites that consistently occur during insufficient sleep. As an exploratory outcome investigators will examine associated changes in metabolites and cognitive performance during insufficient sleep.
Read the detailed description
Impaired sleep affects millions of people each year representing an important public health issue. This project will utilize metabolomics approaches to identify biomarkers in the blood that respond consistently to insufficient sleep. The overall goal of this project is to use a discovery and targeted approach to identify specific small molecules in plasma as candidate biomarkers of insufficient sleep. Investigators will conduct a controlled in-laboratory insufficient sleep protocol where participants receive 2 days of 5 hour sleep opportunities per night on 2 separate occasions. Plasma will be collected for metabolomics analyses every 2 hours (across 24 hours) during scheduled wakefulness at baseline and during insufficient sleep. Participants will complete the insufficient sleep protocol twice, separated by 23 days of sufficient sleep, to identify which plasma metabolites consistently change during insufficient sleep. Investigators anticipate these findings will be the first step in establishing validated biomarkers of impaired sleep that will advance our understanding, assessment and management of health consequences and symptoms associated with insufficient sleep.
- Being tested
- Insufficient Sleep
- Medical subject headings
- Sleep Deprivation, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insufficient SleepBehavioural
2 days with 5 hour sleep opportunity per day
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | 9 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 | 2 days with 5 hour sleep opportunities immediately following baseline on both visit 1 and visit 2. Receives: Behavioral: Insufficient Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Metabolomics Biomarker Fingerprint
Investigators can detect ~4,000 plasma metabolites and will identify which metabolites have consistent, sensitive, and specific responses to insufficient sleep across visits one and two. These metabolites will be identified as candidate biomarkers of insufficient sleep.
Measured: Plasma will be collected for metabolomics analyses every 2 hours during scheduled wakefulness at baseline and during the final 24 hours of insufficient sleep for both visits one and two
Secondary outcomes (1)
Psychomotor Vigilance Test
The Psychomotor Vigilance Test is a reaction time based test designed to evaluate the ability to sustain attention.
Measured: Participants will complete the psychomotor vigilance test every 3 hours during scheduled wakefulness across baseline and insufficient sleep for visits one and two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start19 Jan 2017
- Primary completion22 Feb 2019
- Study completion22 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Kenneth Wright, University of Colorado, Boulder
- Investigators
- Kenneth P Wright, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130803
- Sponsor's protocol ID
- R01HL132150
- Status last verified
- Oct 2020
- First submitted
- 21 Apr 2017
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any data generated from the proposed work that is presented in a peer reviewed journal will be uploaded, de-identified, into the Metabolomics Data Repository and Coordinating Center (DRCC) (U01) through UCSD; http://www.metabolomicsworkbench.org/nihmetabolomics/datasharing.html. In addition, .raw data that is presented in a peer reviewed journal will be archived indefinitely and made available upon request.