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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Arm 1 | Experimental | This will be the first of four arms of controlled sleep manipulation. |
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| Sleep Arm 2 | Experimental | This will be the second of four arms of controlled sleep manipulation. |
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| Sleep Arm 3 | Experimental | This will be the third of four arms of controlled sleep manipulation. |
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| Sleep Arm 4 | Experimental | This will be the fourth of four arms of controlled sleep manipulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Controlled sleep | Behavioral | Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment with controlled lighting and meals. |
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| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilary Uyhelji, PhD | FAA Civil Aerospace Medical Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| FAA Civil Aerospace Medical Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41239200 | Derived | Uyhelji HA, Nicholson SJ, Nesthus TE, Beckel JL, Klerman EB, Czeisler CA, Yuan RK, Arrona-Palacios A, Song P, Ronda JM, Goodson MS. Exploratory development of biomarkers for neurobehavioral performance impairment during sleep loss: comparison across multiple types of sleep deprivation. BMC Genomics. 2025 Nov 14;26(1):1043. doi: 10.1186/s12864-025-12193-6. |
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Raw genetic data that form the basis of a manuscript are expected to be made available after publication in accordance with federal and IRB policy and restrictions.
Release of genetic data forming the basis of a manuscript are expected to be made available after publication. Release will be consistent with Institutional Review Board, journal, and federal requirements.
Access may be controlled, e.g., in accordance with the National Institutes of Health database of Genotypes and Phenotypes (dbGAP) controlled access policy.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 12, 2023 | Sep 18, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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Each participant will undergo one of four separate arms manipulating levels and timing of sleep in a controlled laboratory setting.
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Participants may not know to which study arm they are assigned.
| 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. |
| 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. |
| 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 |
| 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. |
| Oklahoma City |
| Oklahoma |
| 73169 |
| United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |