Comparison Across Multiple Types of Sleep Deprivation

NCT ID: NCT04211506

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-25
• Study Completion Date: 2023-09-12

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.

Conditions

Sleep Deprivation; Sleep Restriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Sleep Arm 1

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

Group Type: EXPERIMENTAL

Controlled sleep

Intervention Type: BEHAVIORAL

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

Sleep Arm 2

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

Group Type: EXPERIMENTAL

Controlled sleep

Intervention Type: BEHAVIORAL

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

Sleep Arm 3

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

Group Type: EXPERIMENTAL

Controlled sleep

Intervention Type: BEHAVIORAL

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

Sleep Arm 4

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

Group Type: EXPERIMENTAL

Controlled sleep

Intervention Type: BEHAVIORAL

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

Interventions

Controlled sleep

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Civil Aerospace Medical Institute

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hilary Uyhelji, PhD

Role: PRINCIPAL_INVESTIGATOR

FAA Civil Aerospace Medical Institute

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

FAA Civil Aerospace Medical Institute

Oklahoma City, Oklahoma, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

GEN10025

Identifier Type: -

Identifier Source: org_study_id