Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Microbiome metrics associated with sleep and/or neurobehavioral performance. |
Fecal samples will be collected and may be analyzed in the future for microbiome differences among subjects, over time, and/or with respect to study conditions and metrics (e.g., differences in microbiome associated with sleep and/or neurobehavioral performance). |
Approximately three fecal samples will be collected over the 10 days in a sleep laboratory for potential future microbiome analyses. |
|
Other |
Metabolite and protein metrics associated with sleep and/or neurobehavioral performance. |
Blood samples will be collected and may be analysed in the future for metabolite, protein, or other molecular differences among subjects, over time, and/or with respect to study conditions and metrics (e.g., differences associated with sleep and/or neurobehavioral performance). |
A series of blood samples will be collected over the 10 days in a sleep laboratory for potential future analyses. |
|
Other |
Additional urine and saliva |
Urine and saliva samples will be collected and may be analyzed in the future for metabolite, protein, or other genetic differences among subjects, over time, and/or with respect to study conditions and metrics |
Saliva and urine samples will be collected frequently during wake over the 10 days in a sleep laboratory for potential future analyses |
|
Other |
Additional physiological metrics. |
Actigraphy, polysomnography, screening data and log/diary information will be collected and may be analysed in the future for comparison with other outcome measures, and particularly associations with sleep, circadian rhythms, and/or neurobehavioral performance. |
Frequent data collection will be made prior to and during the 10 days in a sleep laboratory, including approximately 3 nights of polysomnography. |
|
Primary |
Gene expression changes associated with different sleep patterns. |
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. |
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 |
Neurobehavioral performance changes associated with different sleep patterns. |
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. |
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. |
|
Secondary |
DNA genetic variants associated with sleep and/or neurobehavioral performance. |
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. |
Approximately two oral samples may be taken for DNA analyses during the 10 days in a sleep laboratory. |
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