Comparison Across Multiple Types of Sleep Deprivation
- Conditions
- Sleep DeprivationSleep Restriction
- Interventions
- Behavioral: Controlled sleep
- Registration Number
- NCT04211506
- Lead Sponsor
- Civil Aerospace Medical Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- Healthy
- BMI 18.5-29.9, with consideration of BMIs 30-34.9.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleep Arm 4 Controlled sleep This will be the fourth of four arms of controlled sleep manipulation. Sleep Arm 3 Controlled sleep This will be the third of four arms of controlled sleep manipulation. Sleep Arm 1 Controlled sleep This will be the first of four arms of controlled sleep manipulation. Sleep Arm 2 Controlled sleep This will be the second of four arms of controlled sleep manipulation.
- Primary Outcome Measures
Name Time Method Gene expression changes associated with different sleep patterns. 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 Outcome Measures
Name Time Method 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. Neurobehavioral performance may be compared across time and among study arms with different sleep patterns. Specifically, differences will be examined in subjective and objective neurobehavioral assays (Karolinska sleepiness scale, Performance effort and evaluation rating scale, Digit symbol substitution test, Stroop performance, Raven matrix task, Comparative visual search, Face-name task, Psychomotor vigilance test, Visual analog scale, Track test, and the Balloon analog risk task). Patterns may be sought with relevance to sleep, circadian rhythms, and/or other outcome measures.
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. Analysis of genetic variants may be used to assess inherited genetic differences among subjects and potential relevance to sleep, circadian rhythms, and/or neurobehavioral performance.
Trial Locations
- Locations (2)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
FAA Civil Aerospace Medical Institute
🇺🇸Oklahoma City, Oklahoma, United States