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Sleep Deprivation's Regulation of Immune System Function and Behavior (SS)

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ClinicalTrials.gov Identifier: NCT01730742
Recruitment Status : Unknown
Verified November 2012 by Uppsala University.
Recruitment status was:  Active, not recruiting
First Posted : November 21, 2012
Last Update Posted : November 21, 2012
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Tracking Information
First Submitted Date  ICMJE October 11, 2012
First Posted Date  ICMJE November 21, 2012
Last Update Posted Date November 21, 2012
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2012)
Neutrophil phagocytotic function production [ Time Frame: Change in 4 neutrophil phagocytotic function from baseline to 36hours later (after the nighttime intervention) ]
This project is designed to test the inflammatory capacity of circulating neutrophils. It also aims to investigate if any changes in neutrophil efficacy are governed by alterations in DNA methylation. Measured during 36 hours (at 1930 day 1, 0730 and 1930 day 2, 0730 day 3)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2012)
  • Portion Size Task [ Time Frame: Change in selected portion size from baseline to 1 hr after consuming a caloric preload ]
    Participants will be evaluated on their tendency to choose larger or smaller portions of a variety of meal items on a computer screen. This will be conducted both following sleep deprivation and sleep, and changes over the hour will be compared between these conditions.
  • Neuro-economics task [ Time Frame: Change in purchasing behaviour 1 hr after consuming a caloric preload ]
    Participants will be evaluated on their purchasing behavior with regards to high-calorie and low-calorie food items in a mock supermarket scenario following sleep and sleep deprivation.
  • Circulating hormone levels [ Time Frame: Change in circulating hormone levels from baseline (ie. 1930 - before sleep intervention) to 12hr later (0730 after the nighttime intervention) ]
    Participants will have their circulating hormone levels taken and analyzed, including ghrelin and oxytocin, to determine if sleep deprivation alters hormone levels related primarily to obesity or weight gain
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Deprivation's Regulation of Immune System Function and Behavior
Official Title  ICMJE The Role of Sleep Deprivation in the Regulation of Immune System, Neuroendocrine Responses, and Behavioral Measures.
Brief Summary The study proposes to investigate whether sleep deprivation will affect a variety of measures, including hormones, immune system functioning, and behaviors related to food intake and hunger. It is predicted that sleep deprivation will affect circulating neutrophil activity, and do so via affects on DNA methylation. It is also predicted that sleep deprivation will up-regulate ghrelin, and down-regulate circulating oxytocin. Finally, it is predicted that sleep deprivation will increase participants' tendencies to pick larger portions of food, and also increase their tendency to purchase foods that are more caloric in a mock supermarket scenario.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Sleep Deprivation
  • Sleep
Intervention  ICMJE
  • Behavioral: Neuroeconomics task
    After a night of wakefulness, participants performed the neuroeconomics task (shopping food items in a mock supermarket scenario).
  • Behavioral: Portion Size Task
    Participants are given a computer program that gives them the opportunity to choose the portions of a variety of food items that they would ideally like to consume
  • Procedure: Blood sample
    After a night of wakefulness, a blood sample was taken to assess the level and efficacy of circulating neutrophils, as well as to assay blood serum and plasma for the presence of hormones involved in hunger such as oxytocin and ghrelin
Study Arms  ICMJE
  • Experimental: Sleep deprivation
    Total sleep deprivation: participants were required to stay up for the entire night before a 'Blood Sample' was taken and the 'Neuroeconomics task' and 'Portion size task' were performed
    Interventions:
    • Behavioral: Neuroeconomics task
    • Behavioral: Portion Size Task
    • Procedure: Blood sample
  • Experimental: Sleep
    Sleep: participants had an 8-h sleep opportunity before a 'Blood Sample' was taken and the 'Neuroeconomics task' and 'Portion size task' were performed
    Interventions:
    • Behavioral: Neuroeconomics task
    • Behavioral: Portion Size Task
    • Procedure: Blood sample
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: November 15, 2012)
18
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2013
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male
  • Age 18-35y
  • Healthy (self-reported) and not on medication
  • Non-smoking
  • Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported)

Exclusion Criteria:

  • Major illness
  • Taking any serious medications
  • Any sleep conditions (e.g. irregular bedtimes, sleep complaints)
  • Any dietary issues with the food items provided
  • A history of endocrine or psychiatric disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01730742
Other Study ID Numbers  ICMJE 192837465
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christian Benedict, PhD dept. of Neuroscience, Uppsala University
PRS Account Uppsala University
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP