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Neurobehavioral Effects of Partial Sleep Deprivation

Primary Purpose

Control, 1 Night Recovery Sleep, 3 Nights Recovery Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Control

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Unit for Experimental Psychiatry, Sleep and Chronobiology Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

1 Recovery Night

3 Recovery Nights

5 Recovery Nights

Arm Description

10 hours time-in-bed all nights of study

2 baseline nights, five nights sleep restriction, 1 recovery night, five nights sleep restriction, 4 recovery nights

2 baseline nights, five nights sleep restriction, 3 recovery nights, five nights sleep restriction, 2 recovery nights

2 baseline nights, five nights sleep restriction, 5 recovery nights, five nights sleep restriction, 1 recovery nights

Outcomes

Primary Outcome Measures

Psychomotor Vigilance Test
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.

Secondary Outcome Measures

Full Information

First Posted
April 10, 2014
Last Updated
June 9, 2015
Sponsor
University of Pennsylvania
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02128737
Brief Title
Neurobehavioral Effects of Partial Sleep Deprivation
Official Title
Neurobehavioral Effects of Partial Sleep Deprivation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Control, 1 Night Recovery Sleep, 3 Nights Recovery Sleep, 5 Nights Recovery Sleep

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
10 hours time-in-bed all nights of study
Arm Title
1 Recovery Night
Arm Type
Experimental
Arm Description
2 baseline nights, five nights sleep restriction, 1 recovery night, five nights sleep restriction, 4 recovery nights
Arm Title
3 Recovery Nights
Arm Type
Experimental
Arm Description
2 baseline nights, five nights sleep restriction, 3 recovery nights, five nights sleep restriction, 2 recovery nights
Arm Title
5 Recovery Nights
Arm Type
Experimental
Arm Description
2 baseline nights, five nights sleep restriction, 5 recovery nights, five nights sleep restriction, 1 recovery nights
Intervention Type
Behavioral
Intervention Name(s)
Sleep
Primary Outcome Measure Information:
Title
Psychomotor Vigilance Test
Description
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.
Time Frame
Assessed everyday of the in-laboratory study (17 days) and is completed every 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David F Dinges, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit for Experimental Psychiatry, Sleep and Chronobiology Laboratory
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28364451
Citation
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.
Results Reference
derived
PubMed Identifier
24965304
Citation
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.
Results Reference
derived

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Neurobehavioral Effects of Partial Sleep Deprivation

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