- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02128737
Neurobehavioral Effects of Partial Sleep Deprivation
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Unit for Experimental Psychiatry, Sleep and Chronobiology Laboratory
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
A total of N=87 adult subjects (aged 21-50 yr), N=43 females and N=44 males of all ethnicities, will be randomized to the 3 different conditions (n=26 for each of 2 experimental conditions; n=11 for the control condition) for the 17-night protocol or assigned to the 5-night experimental recovery condition (n=24) for the 19-night protocol. Subjects must also be comparable in terms of their homeostatic and circadian sleep-wake regulation parameters. In order to be eligible to participate, subjects must meet the following inclusion criteria:
- Age between 21 and 50 years (average age of our current protocols is 31 years)
- Body mass index (BMI) within 20.5% of normal
- Stable, normally-timed sleep-wake cycle as determined by interview, 2-week daily sleep log, and 2-week wrist actigraphic evidence, and defined by:
- Habitual nocturnal sleep duration between 6.5h and 8.5h
- Habitual morning awakening between 0600h and 0930h
Exclusion Criteria:
- No evidence of habitual napping
- No shift work, transmeridian travel or irregular sleep/wake routine in the past 60 days
- No sleep disorder, determined by history, actigraph, pulse oximetry and PSG
- No history of mania or psychosis
- No current depression as determined by the Beck Depression Inventory
- No alcohol or drug abuse in the past year based upon history and urine toxicology screen
- Not a current smoker
- No acute, chronic, or debilitating medical conditions, major Axis I psychiatric illness, epilepsy, or thyroid disease, based on history, physical exam, blood and urine chemistries, and CBC
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
10 hours time-in-bed all nights of study
|
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Experimental: 1 Recovery Night
2 baseline nights, five nights sleep restriction, 1 recovery night, five nights sleep restriction, 4 recovery nights
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Experimental: 3 Recovery Nights
2 baseline nights, five nights sleep restriction, 3 recovery nights, five nights sleep restriction, 2 recovery nights
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Experimental: 5 Recovery Nights
2 baseline nights, five nights sleep restriction, 5 recovery nights, five nights sleep restriction, 1 recovery nights
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychomotor Vigilance Test
Time Frame: Assessed everyday of the in-laboratory study (17 days) and is completed every 2 hours
|
3, 10 or 20 minute simple, high-signal-load reaction time (RT)-based test invented by our group and designed to evaluate the ability to sustain attention and respond in a timely manner to salient signals.
|
Assessed everyday of the in-laboratory study (17 days) and is completed every 2 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David F Dinges, PhD, University of Pennsylvania
Publications and helpful links
General Publications
- Spaeth AM, Dinges DF, Goel N. Objective Measurements of Energy Balance Are Associated With Sleep Architecture in Healthy Adults. Sleep. 2017 Jan 1;40(1):zsw018. doi: 10.1093/sleep/zsw018.
- Spaeth AM, Dinges DF, Goel N. Sex and race differences in caloric intake during sleep restriction in healthy adults. Am J Clin Nutr. 2014 Aug;100(2):559-66. doi: 10.3945/ajcn.114.086579. Epub 2014 Jun 25.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 810896
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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