Comparison Across Multiple Types of Sleep Deprivation

Sleep Deprivation Clinical Trial

Official title:

Comparison Across Multiple Types of Sleep Deprivation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211506
• Other study ID #: GEN10025
• Status: Completed
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: September 12, 2023

Study information

• Verified date: September 2023
• Source: Civil Aerospace Medical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 12, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Deprivation
• Sleep Restriction

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	FAA Civil Aerospace Medical Institute	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Civil Aerospace Medical Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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
Other	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.
Primary	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	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.
Secondary	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.