- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01581125
Sleep Duration Required to Restore Performance During Chronic Sleep Restriction
July 15, 2016 updated by: Elizabeth B. Klerman, Brigham and Women's Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- Prescription medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
Sleep and Wake durations for arm 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
PVT during waking for arms 1 and 2 during the 32-day inpatient portion of the protocol
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McHill AW, Hull JT, Cohen DA, Wang W, Czeisler CA, Klerman EB. Chronic sleep restriction greatly magnifies performance decrements immediately after awakening. Sleep. 2019 May 1;42(5):zsz032. doi: 10.1093/sleep/zsz032.
- McHill AW, Hull JT, McMullan CJ, Klerman EB. Chronic Insufficient Sleep Has a Limited Impact on Circadian Rhythmicity of Subjective Hunger and Awakening Fasted Metabolic Hormones. Front Endocrinol (Lausanne). 2018 Jun 12;9:319. doi: 10.3389/fendo.2018.00319. eCollection 2018.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
March 22, 2012
First Submitted That Met QC Criteria
April 18, 2012
First Posted (Estimate)
April 19, 2012
Study Record Updates
Last Update Posted (Estimate)
July 18, 2016
Last Update Submitted That Met QC Criteria
July 15, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIH R01 HL114088-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep
-
University of Wisconsin, MadisonPhilips HealthcareCompletedSleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
-
Brain Electrophysiology Laboratory CompanyRecruiting
-
University GhentEuropean CommissionCompleted
-
Mahidol UniversityRamathibodi HospitalNot yet recruitingSleep Inertia | Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization | Night Shift WorkThailand
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
-
Universidade Federal de PernambucoEnrolling by invitationSleep | Obstructive Sleep Apnea (OSA)Brazil
-
Atlas UniversityCompletedSleep | Surgery | Sleep QualityTurkey (Türkiye)
-
Mersin UniversityCompletedSleep Quality | Sleep PerceptionTurkey (Türkiye)
-
Hospital Felicio RochoNot yet recruitingSleep Apnea/Hypopnea Syndrome | Sleep Apnea Syndrome, Obstructive | Sleep Apnea Syndrome (OSAS) | Sleep Apnea - Obstructive
-
Brigham and Women's HospitalNot yet recruitingObstructive Sleep Apnea | Sleep-disordered BreathingUnited States
Clinical Trials on Sleep:wake 2
-
University College, LondonMoorfields Eye Hospital NHS Foundation Trust; Targeted Genetics CorporationCompletedRetinal DegenerationUnited Kingdom
-
MED-EL Elektromedizinische Geräte GesmbHCompletedHearing Loss | Hearing Loss, Sensorineural | Hearing Loss, BilateralGermany
-
Vanderbilt University Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
Yuhan CorporationCompletedRheumatic ArthritisKorea, Republic of
-
Medifast, Inc.Completed
-
Vanderbilt University Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)RecruitingFamilial HypercholesterolemiaUnited States
-
University of South CarolinaTerminatedSedentary Lifestyle | Knee Osteoarthritis | Knee Injuries | Knee Pain ChronicUnited States
-
University of PennsylvaniaNational Cancer Institute (NCI); PfizerCompleted
-
Metabolic Technologies Inc.National Institute on Aging (NIA); Vanderbilt UniversityCompleted
-
Metabolic Technologies Inc.National Institute on Aging (NIA); Vanderbilt UniversityCompleted