Sleep Duration Required to Restore Performance During Chronic Sleep Restriction
This study is currently recruiting participants.
Verified March 2013 by Brigham and Women's Hospital
Sponsor:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Elizabeth B. Klerman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01581125
First received: March 22, 2012
Last updated: March 7, 2013
Last verified: March 2013
| Tracking Information | |||||
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| First Received Date ICMJE | March 22, 2012 | ||||
| Last Updated Date | March 7, 2013 | ||||
| Start Date ICMJE | April 2012 | ||||
| Estimated Primary Completion Date | June 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01581125 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | June 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01581125 | ||||
| Other Study ID Numbers ICMJE | NIH R01 HL114088-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Elizabeth B. Klerman, Brigham and Women's Hospital | ||||
| Study Sponsor ICMJE | Brigham and Women's Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Brigham and Women's Hospital | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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