Trial record 7 of 82 for:    "Sleep Deprivation"

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01730742
First received: October 11, 2012
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Sleep Deprivation
Sleep
Behavioral: Neuroeconomics task
Behavioral: Portion Size Task
Procedure: Blood sample

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Role of Sleep Deprivation in the Regulation of Immune System, Neuroendocrine Responses, and Behavioral Measures.

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Neutrophil phagocytotic function production [ Time Frame: Change in 4 neutrophil phagocytotic function from baseline to 36hours later (after the nighttime intervention) ] [ Designated as safety issue: No ]

    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)



Secondary Outcome Measures:
  • Portion Size Task [ Time Frame: Change in selected portion size from baseline to 1 hr after consuming a caloric preload ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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


Enrollment: 18
Study Start Date: February 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730742

Locations
Sweden
Uppsala University
Uppsala, Sweden, 75105
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Christian Benedict, PhD dept. of Neuroscience, Uppsala University
  More Information

No publications provided by Uppsala University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01730742     History of Changes
Other Study ID Numbers: 192837465
Study First Received: October 11, 2012
Last Updated: November 15, 2012
Health Authority: Sweden: Regional Ethical Review Board

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 April 17, 2014