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

November 15, 2012 updated by: Uppsala University

The Role of Sleep Deprivation in the Regulation of Immune System, Neuroendocrine Responses, and Behavioral Measures.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Sweden
      • Uppsala, Sweden, 75105
        • Uppsala University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: 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
Behavioral: Neuroeconomics task
After a night of wakefulness, participants performed the neuroeconomics task (shopping food items in a mock supermarket scenario).
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: 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
Behavioral: Neuroeconomics task
After a night of wakefulness, participants performed the neuroeconomics task (shopping food items in a mock supermarket scenario).
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Change in 4 neutrophil phagocytotic function from baseline to 36hours later (after the nighttime intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Change in selected portion size from baseline to 1 hr after consuming a caloric preload
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.
Change in purchasing behaviour 1 hr after consuming a caloric preload
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
Change in circulating hormone levels from baseline (ie. 1930 - before sleep intervention) to 12hr later (0730 after the nighttime intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uppsala University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian Benedict, PhD, dept. of Neuroscience, Uppsala University

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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 192837465

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.

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