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OpenTrials
Completed

NCT Number: NCT04211506

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.

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Key information

Conditions

Sleep Deprivation Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Restriction Sleep Wake Disorders

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Controlled sleep

Behavioral

Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment with controlled lighting and meals.

Primary outcomes

  1. Gene expression changes associated with different sleep patterns.

    Time frame: 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 outcomes

  1. Neurobehavioral performance changes associated with different sleep patterns.

    Time frame: 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.

  2. DNA genetic variants associated with sleep and/or neurobehavioral performance.

    Time frame: 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 outcomes

  1. Microbiome metrics associated with sleep and/or neurobehavioral performance.

    Time frame: 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).

  2. Metabolite and protein metrics associated with sleep and/or neurobehavioral performance.

    Time frame: 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).

  3. Additional urine and saliva

    Time frame: 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

  4. Additional physiological metrics.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Civil Aerospace Medical Institute

Fed

Collaborators

  • Brigham and Women's Hospital

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 26, 2019
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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