Comparison Across Multiple Types of Sleep Deprivation

NCT04211506 | Completed

• 1 other identifier: GEN10025
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep Deprivation; Sleep Restriction

Keywords

Neurobehavioral performance; Genetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Neurobehavioral performance changes associated with different sleep patterns.

  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.

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

Other Outcomes (4)

• Microbiome metrics 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.

• Metabolite and protein metrics 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

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

Study Arms (4)

Sleep Arm 1

EXPERIMENTAL

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

Behavioral: Controlled sleep

Sleep Arm 2

EXPERIMENTAL

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

Behavioral: Controlled sleep

Sleep Arm 3

EXPERIMENTAL

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

Behavioral: Controlled sleep

Sleep Arm 4

EXPERIMENTAL

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

Behavioral: Controlled sleep

Interventions

Controlled sleep BEHAVIORAL

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

Sleep Arm 1; Sleep Arm 2; Sleep Arm 3; Sleep Arm 4

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• BMI 18.5-29.9, with consideration of BMIs 30-34.9.

You may not qualify if:

• 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

Sponsors & Collaborators

• Civil Aerospace Medical Institute: lead
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

FAA Civil Aerospace Medical Institute

Oklahoma City, Oklahoma, 73169, United States

Location

Related Publications (1)

• 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.

  PMID: 41239200 DERIVED

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

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

Study Officials

• Hilary Uyhelji, PhD

  FAA Civil Aerospace Medical Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants may not know to which study arm they are assigned.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 26, 2019
• Study Start: August 25, 2020
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• 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.
• 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.

Locations

US (2)