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Sleep Duration Required to Restore Performance During Chronic Sleep Restriction

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: NCT01581125
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
Elizabeth B. Klerman, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE April 19, 2012
Last Update Posted Date July 18, 2016
Study Start Date  ICMJE April 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2012)
Psychomotor Vigilance Task (PVT) performance [ Time Frame: PVT during waking for arms 1 and 2 during the 32-day inpatient portion of the protocol ]
PVT metrics are reaction time. It is measured when the participants are awake during the inpatient portion of the protocol.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Duration Required to Restore Performance During Chronic Sleep Restriction
Official Title  ICMJE Sleep Duration Required to Restore Performance During Chronic Sleep Restriction
Brief Summary The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase.
Detailed Description The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase. Inpatient sleep and performance data will be collected from healthy volunteers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE
  • Sleep
  • Sleep Deprivation
  • Insufficient Sleep Syndrome
Intervention  ICMJE
  • Behavioral: Sleep:wake 1
    Sleep and Wake durations for arm 1
  • Behavioral: Sleep:wake 2
    Sleep and Wake durations for arm2
Study Arms  ICMJE
  • Experimental: Sleep:wake 2
    Sleep and wake durations for arm 2 for inpatient portion of protocol. .There are a variety of sleep and wake durations during the protocol; some of these are longer and some are shorter and some are the same as in arm 1.
    Intervention: Behavioral: Sleep:wake 2
  • Experimental: Sleep:wake 1
    Sleep and wake durations for arm 1 of the inpatient portion of the protocol. There are a variety of sleep and wake durations during the protocol; some of these are longer and some are shorter and some are the same as in arm 2.
    Intervention: Behavioral: Sleep:wake 1
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2016)
19
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2012)
20
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Prescription medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01581125
Other Study ID Numbers  ICMJE NIH R01 HL114088-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth B. Klerman, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elizabeth B Klerman, MD PhD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP