Comparison Across Multiple Types of Sleep Deprivation

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.

Study Overview

• Status: Completed
• Conditions: Sleep Deprivation; Sleep Restriction
• Intervention / Treatment: Behavioral: Controlled 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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Klerman, PhD, MD; Phone Number: 617-732-8145; Email: ebklerman@hms.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73169
      • FAA Civil Aerospace Medical Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Civil Aerospace Medical Institute
• Collaborators: Brigham and Women's Hospital
• Investigators: Principal Investigator: Hilary Uyhelji, PhD, FAA Civil Aerospace Medical Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): September 12, 2023
• Study Completion (Actual): September 12, 2023

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Genetic; Neurobehavioral performance
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Deprivation
• Other Study ID Numbers: GEN10025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: Access may be controlled, e.g., in accordance with the National Institutes of Health database of Genotypes and Phenotypes (dbGAP) controlled access policy.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No