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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581125
Contacts
| Contact: Elizabeth B Klerman, MD PhD | 617-732-5500 ext 33848 | ebklerman@rics.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: | March 7, 2013 |
| 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 Sleep Disorders Nervous System Diseases |
Neurologic Manifestations Signs and Symptoms Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013