Clinical trial NCT04211506: Comparison Across Multiple Types of Sleep Deprivation
Official title: Comparison Across Multiple Types of Sleep Deprivation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Sleep Restriction
Keywords: Neurobehavioral performance
Genetic
Lead sponsor: Civil Aerospace Medical Institute
Sponsor class: FED
Collaborators: name: Brigham and Women's Hospital
First posted: 2019-12-26
Enrollment: 59
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant will undergo one of four separate arms manipulating levels and timing of sleep in a controlled laboratory setting.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* Healthy
* 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

Primary outcomes:
measure: Gene expression changes associated with different sleep patterns.
timeFrame: 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.
Secondary outcomes:
measure: Neurobehavioral performance changes associated with different sleep patterns.
timeFrame: 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.
measure: DNA genetic variants associated with sleep and/or neurobehavioral performance.
timeFrame: Approximately two oral samples may be taken for DNA analyses during the 10 days in a sleep laboratory.
Other outcomes:
measure: Microbiome metrics associated with sleep and/or neurobehavioral performance.
timeFrame: Approximately three fecal samples will be collected over the 10 days in a sleep laboratory for potential future microbiome analyses.
measure: Metabolite and protein metrics associated with sleep and/or neurobehavioral performance.
timeFrame: A series of blood samples will be collected over the 10 days in a sleep laboratory for potential future analyses.
measure: Additional urine and saliva
timeFrame: Saliva and urine samples will be collected frequently during wake over the 10 days in a sleep laboratory for potential future analyses
measure: Additional physiological metrics.
timeFrame: Frequent data collection will be made prior to and during the 10 days in a sleep laboratory, including approximately 3 nights of polysomnography.
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Oklahoma City
country: United States
facility: FAA Civil Aerospace Medical Institute
state: Oklahoma
Study officials:
affiliation: FAA Civil Aerospace Medical Institute
name: Hilary Uyhelji, PhD
role: PRINCIPAL_INVESTIGATOR
References: