Comparison Across Multiple Types of Sleep Deprivation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison Across Multiple Types of Sleep Deprivation

Conditions
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Sleep Deprivation, Sleep Restriction

Intervention / Treatment
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* Behavioral: Controlled sleep


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each participant will undergo one of four separate arms manipulating levels and timing of sleep in a controlled laboratory setting.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Arm 1<br>This will be the first of four arms of controlled sleep manipulation. | Behavioral: Controlled sleep<br>* Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment with controlled lighting and meals.<br>|
| Experimental: Sleep Arm 2<br>This will be the second of four arms of controlled sleep manipulation. | Behavioral: Controlled sleep<br>* Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment with controlled lighting and meals.<br>|
| Experimental: Sleep Arm 3<br>This will be the third of four arms of controlled sleep manipulation. | Behavioral: Controlled sleep<br>* Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment with controlled lighting and meals.<br>|
| Experimental: Sleep Arm 4<br>This will be the fourth of four arms of controlled sleep manipulation. | Behavioral: Controlled sleep<br>* Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment with controlled lighting and meals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurobehavioral performance, Genetic