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Sleep Duration Required to Restore Performance During Chronic Sleep Restriction

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Elizabeth B. Klerman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01581125
First received: March 22, 2012
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Sleep
Sleep Deprivation
Insufficient Sleep Syndrome
Behavioral: Sleep:wake 1
Behavioral: Sleep:wake 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Sleep Duration Required to Restore Performance During Chronic Sleep Restriction

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Psychomotor Vigilance Task (PVT) performance [ Time Frame: PVT during waking for arms 1 and 2 during the 32-day inpatient portion of the protocol ] [ Designated as safety issue: No ]
    PVT metrics are reaction time. It is measured when the participants are awake during the inpatient portion of the protocol.


Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Sleep:wake 2
Sleep and Wake durations for arm2
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.
Behavioral: Sleep:wake 1
Sleep and Wake durations for arm 1

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Prescription medications
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581125

Contacts
Contact: Elizabeth B Klerman, MD PhD 617-732-5500 ext 33848 ebklerman@research.bwh.harvard.edu

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Recruiters    617-732-4311    light@rics.bwh.harvard.edu   
Principal Investigator: Elizabeth B Klerman, MD PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Elizabeth B Klerman, MD PhD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Elizabeth B. Klerman, Associate Professor, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01581125     History of Changes
Other Study ID Numbers: NIH R01 HL114088-01
Study First Received: March 22, 2012
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Inpatients
Health Normalcy
circadian rhythm

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

ClinicalTrials.gov processed this record on November 27, 2014