NCT02128737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 11, 2015

Status Verified

April 1, 2014

Enrollment Period

5.3 years

First QC Date

April 10, 2014

Last Update Submit

June 9, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Assessed everyday of the in-laboratory study (17 days) and is completed every 2 hours

Study Arms (4)

Control

NO INTERVENTION

10 hours time-in-bed all nights of study

1 Recovery Night

EXPERIMENTAL

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

Behavioral: Sleep

3 Recovery Nights

EXPERIMENTAL

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

Behavioral: Sleep

5 Recovery Nights

EXPERIMENTAL

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

Behavioral: Sleep

Interventions

SleepBEHAVIORAL
1 Recovery Night3 Recovery Nights5 Recovery Nights

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit for Experimental Psychiatry, Sleep and Chronobiology Laboratory

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

MeSH Terms

Interventions

Sleep

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David F Dinges, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

May 1, 2014

Study Start

December 1, 2009

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 11, 2015

Record last verified: 2014-04

Locations