Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neurobehavioral Effects of Partial Sleep Deprivation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02128737
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : June 11, 2015
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
This project continues an innovative line of research on how to optimally use sleep as an intervention to promote cognitive recovery from, and resistance to, the neurobehavioral risks posed by chronic partial sleep deprivation. Chronic insufficient sleep is estimated to affect at least 20% of adults. It can result from medical conditions and sleep disorders, as well as work demands, and social or domestic responsibilities. It is associated with significant clinical morbidity, and directly causes errors and accidents that are due to its adverse neurobehavioral effects on alertness, mood, and cognitive functions. In seminal experiments conducted under this grant, we showed that the neurobehavioral effects of chronic sleep restriction accumulate to severe levels in a few days, without the full awareness of the affected individuals, and that recovery from chronic sleep restriction requires more sleep than previously assumed. We also discovered that recovery from chronic sleep was illusory, because it masked a heightened neurobehavioral vulnerability to even a single post-recovery night of sleep restriction. The implications of these findings are that apparent recovery from chronic sleep restriction masks a more severe cognitive response to subsequent sleep restriction suggesting that there are longer time constants in the brain for neurobehavioral recovery from chronic sleep restriction. In light of this finding, we now seek to determine whether additional nights of extended recovery sleep will reduce the heightened vulnerability induced by prior exposure to sleep restriction. A total of 87 healthy adults (ages 21-50) will be studied in the laboratory during a 17-night (N=63) and a 19-night (N=24) protocol evaluating cognitive, psychological and physiological responses to varying recovery days between two sleep-restriction periods. The results will establish the number of nights of recovery sleep needed to prevent accelerated deterioration during a subsequent period of sleep restriction. The findings will advance theoretical understanding of sleep homeostasis and its relationship to cognitive functions, as well as inform theories of sleep need, and have substantial implications for sleep biology, for the treatment of clinical disorders that regularly disrupt sleep, and for managing lifestyle factors that frequently restrict sleep.

Condition or disease Intervention/treatment Phase
Control 1 Night Recovery Sleep 3 Nights Recovery Sleep 5 Nights Recovery Sleep Behavioral: Sleep Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neurobehavioral Effects of Partial Sleep Deprivation
Study Start Date : December 2009
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
No Intervention: Control
10 hours time-in-bed all nights of study
Experimental: 1 Recovery Night
2 baseline nights, five nights sleep restriction, 1 recovery night, five nights sleep restriction, 4 recovery nights
Behavioral: Sleep
Experimental: 3 Recovery Nights
2 baseline nights, five nights sleep restriction, 3 recovery nights, five nights sleep restriction, 2 recovery nights
Behavioral: Sleep
Experimental: 5 Recovery Nights
2 baseline nights, five nights sleep restriction, 5 recovery nights, five nights sleep restriction, 1 recovery nights
Behavioral: Sleep



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  1. Age between 21 and 50 years (average age of our current protocols is 31 years)
  2. Body mass index (BMI) within 20.5% of normal
  3. Stable, normally-timed sleep-wake cycle as determined by interview, 2-week daily sleep log, and 2-week wrist actigraphic evidence, and defined by:
  4. Habitual nocturnal sleep duration between 6.5h and 8.5h
  5. Habitual morning awakening between 0600h and 0930h

Exclusion Criteria:

  1. No evidence of habitual napping
  2. No shift work, transmeridian travel or irregular sleep/wake routine in the past 60 days
  3. No sleep disorder, determined by history, actigraph, pulse oximetry and PSG
  4. No history of mania or psychosis
  5. No current depression as determined by the Beck Depression Inventory
  6. No alcohol or drug abuse in the past year based upon history and urine toxicology screen
  7. Not a current smoker
  8. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128737


Locations
Layout table for location information
United States, Pennsylvania
Unit for Experimental Psychiatry, Sleep and Chronobiology Laboratory
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: David F Dinges, PhD University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02128737     History of Changes
Other Study ID Numbers: 810896
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: April 2014

Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders