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Comparison Across Multiple Types of Sleep Deprivation

Primary Purpose

Sleep Deprivation, Sleep Restriction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Controlled sleep

About this trial

This is an interventional other trial for Sleep Deprivation focused on measuring Neurobehavioral performance, Genetic

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Brigham and Women's Hospital
FAA Civil Aerospace Medical Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Sleep Arm 1

Sleep Arm 2

Sleep Arm 3

Sleep Arm 4

Arm Description

This will be the first of four arms of controlled sleep manipulation.

This will be the second of four arms of controlled sleep manipulation.

This will be the third of four arms of controlled sleep manipulation.

This will be the fourth of four arms of controlled sleep manipulation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04211506

First Posted

December 5, 2019

Last Updated

September 28, 2023

Sponsor

Civil Aerospace Medical Institute

Collaborators

Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04211506

Brief Title

Comparison Across Multiple Types of Sleep Deprivation

Official Title

Comparison Across Multiple Types of Sleep Deprivation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

August 25, 2020 (Actual)

Primary Completion Date

September 12, 2023 (Actual)

Study Completion Date

September 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Civil Aerospace Medical Institute

Collaborators

Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Deprivation, Sleep Restriction

Keywords

Neurobehavioral performance, Genetic

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Each participant will undergo one of four separate arms manipulating levels and timing of sleep in a controlled laboratory setting.

Masking

Participant

Masking Description

Participants may not know to which study arm they are assigned.

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sleep Arm 1

Arm Type

Experimental

Arm Description

This will be the first of four arms of controlled sleep manipulation.

Arm Title

Sleep Arm 2

Arm Type

Experimental

Arm Description

This will be the second of four arms of controlled sleep manipulation.

Arm Title

Sleep Arm 3

Arm Type

Experimental

Arm Description

This will be the third of four arms of controlled sleep manipulation.

Arm Title

Sleep Arm 4

Arm Type

Experimental

Arm Description

This will be the fourth of four arms of controlled sleep manipulation.

Intervention Type

Behavioral

Intervention Name(s)

Controlled sleep

Intervention Description

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

Primary Outcome Measure Information:

Title

Gene expression changes associated with different sleep patterns.

Description

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.

Secondary Outcome Measure Information:

Title

Neurobehavioral performance changes associated with different sleep patterns.

Description

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.

Title

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

Description

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.

Time Frame

Approximately two oral samples may be taken for DNA analyses during the 10 days in a sleep laboratory.

Other Pre-specified Outcome Measures:

Title

Microbiome metrics associated with sleep and/or neurobehavioral performance.

Description

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).

Time Frame

Approximately three fecal samples will be collected over the 10 days in a sleep laboratory for potential future microbiome analyses.

Title

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

Description

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).

Time Frame

A series of blood samples will be collected over the 10 days in a sleep laboratory for potential future analyses.

Title

Additional urine and saliva

Description

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

Time Frame

Saliva and urine samples will be collected frequently during wake over the 10 days in a sleep laboratory for potential future analyses

Title

Additional physiological metrics.

Description

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.

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hilary Uyhelji, PhD

Organizational Affiliation

FAA Civil Aerospace Medical Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

FAA Civil Aerospace Medical Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73169

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Comparison Across Multiple Types of Sleep Deprivation

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