Sleep Deprivation and Energy Balance (Sleep)
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ClinicalTrials.gov Identifier: NCT00935402 |
Recruitment Status
:
Completed
First Posted
: July 9, 2009
Last Update Posted
: February 23, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Behavioral: Sleep | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Sleep Deprivation and Energy Balance |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | July 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: Short Sleep
Subjects are permitted to spend 4 hours in bed per night for 5 consecutive nights. Subjects are inpatients for a period of 6 days.
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Behavioral: Sleep
Subjects are randomly assigned to one of 2 arms sequence: short followed by regular or regular followed by short. Each arm is 6 days in length and separated by a 2-4 week washout period.
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Active Comparator: Regular Sleep
Subjects are permitted to spend 9 hours in bed per night for 5 nights. Subjects are inpatients for a period of 6 days.
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Behavioral: Sleep
Subjects are randomly assigned to one of 2 arms sequence: short followed by regular or regular followed by short. Each arm is 6 days in length and separated by a 2-4 week washout period.
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- Resting metabolic rate [ Time Frame: Day 5 of each arm ]
- Food intake [ Time Frame: Days 5-6 of each arm ]
- Hormone Measurements [ Time Frame: Daily fasting, and every 2 hours on day 4 of each arm ]
- Regional brain activity [ Time Frame: Day 6 of each arm ]
- Energy expenditure [ Time Frame: Each 6 day arm ]

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Ages Eligible for Study: | 30 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Body mass index 22-25 kg/m2
- Right-handed
- Sleep 7-9 hours/night
- Normal score on Pittsburgh Quality of Sleep questionnaire, Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness
Exclusion Criteria:
- Smoker
- Neurological, medical, or psychiatric disorder
- Diabetics
- History of eating disorders
- Sleep disorders
- Travel across time zones within 4 weeks of the study
- History of drug and alcohol abuse
- Shift worker
- Caffeine intake > 300 mg/d
- Excessive daytime sleepiness
- Regular napping
- History of drowsy driving
- Pregnancy or within 1 y post-partum
- Heavy equipment operator or commercial long-distance driver
- Contra-indications for MRI scanning

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935402
United States, New York | |
Clinilabs | |
New York, New York, United States, 10019 | |
St. Luke's/Roosevelt Hospital | |
New York, New York, United States, 10025 | |
Columbia University | |
New York, New York, United States, 10036 |
Principal Investigator: | Marie-Pierre St-Onge, Ph.D | St. Luke's-Roosevelt Hospital Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Marie-Pierre St-Onge/Research Associate, St. Luke's/Roosevelt Hospital |
ClinicalTrials.gov Identifier: | NCT00935402 History of Changes |
Other Study ID Numbers: |
R01HL091352-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | July 9, 2009 Key Record Dates |
Last Update Posted: | February 23, 2011 |
Last Verified: | May 2010 |
Keywords provided by St. Luke's-Roosevelt Hospital Center:
Energy balance Weight management Food intake Energy expenditure |
Additional relevant MeSH terms:
Sleep Deprivation Dyssomnias Sleep Wake Disorders Nervous System Diseases |
Neurologic Manifestations Signs and Symptoms Mental Disorders |