Skip to main content
Clinical Trials/NCT04211506
NCT04211506
Completed
Not Applicable

Comparison Across Multiple Types of Sleep Deprivation

Civil Aerospace Medical Institute2 sites in 1 country59 target enrollmentAugust 25, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Deprivation
Sponsor
Civil Aerospace Medical Institute
Enrollment
59
Locations
2
Primary Endpoint
Gene expression changes associated with different sleep patterns.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study is designed to assess neurobehavioral performance, as well as genetic and other physiological changes associated with variations in timing and quantity of sleep.

Detailed Description

During a 1.5 week inpatient laboratory protocol, subjects will undergo one of four parallel sleep conditions. Subjects will be randomly assigned to each condition group. During their time in the laboratory, biological samples (e.g., blood) will be collected for genetic and other analyses, and sleep quantity and quality will be monitored. Additionally responses on neurobehavioral tests and surveys will be monitored for differences among the groups.

Registry
clinicaltrials.gov
Start Date
August 25, 2020
End Date
September 12, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Civil Aerospace Medical Institute
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • BMI 18.5-29.9, with consideration of BMIs 30-34.9.

Exclusion Criteria

  • Medication use, with potential consideration for contraceptives.
  • Color blindness
  • Recent nightwork, shiftwork, or travel across greater than two time zones
  • Pregnant or within 6 months post-partum

Outcomes

Primary Outcomes

Gene expression changes associated with different sleep patterns.

Time Frame: Samples for gene expression will be collected at frequent intervals over 10 days in a sleep laboratory. Subjects will be in a time-free environment, and not told sampling frequency.

Levels of expression of all genes may be compared across time and among study arms with different sleep patterns using RNA-Seq and differential expression analysis with generalized linear models. Patterns may be sought with and potential relevance to sleep, circadian rhythms, and/or neurobehavioral performance.

Secondary Outcomes

  • Neurobehavioral performance changes associated with different sleep patterns.(Neurobehavioral assays may be conducted at frequent intervals over 10 days in a sleep laboratory. Subjects will be in a time-free environment, and not told assay frequency.)
  • DNA genetic variants associated with sleep and/or neurobehavioral performance.(Approximately two oral samples may be taken for DNA analyses during the 10 days in a sleep laboratory.)

Study Sites (2)

Loading locations...

Similar Trials