Sleep Deprivation, Sleep Restriction
Conditions
Keywords
Neurobehavioral performance, Genetic
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.
Interventions
BEHAVIORALControlled sleep
Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment with controlled lighting and meals.
Sponsors
Brigham and Women's Hospital
Civil Aerospace Medical Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants may not know to which study arm they are assigned.
Intervention model description
Each participant will undergo one of four separate arms manipulating levels and timing of sleep in a controlled laboratory setting.
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Microbiome metrics 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. | 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). |
| Additional physiological metrics. | Frequent data collection will be made prior to and during the 10 days in a sleep laboratory, including approximately 3 nights of polysomnography. | 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. |
| Metabolite and protein metrics 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. | 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). |
| Additional urine and saliva | Saliva and urine samples will be collected frequently during wake over the 10 days in a sleep laboratory for potential future analyses | 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 |
Countries
United States
Outcome results
None listed