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Sleep DeprivationNCT01800253

The Effects of Acute Total Sleep Deprivation Versus Normal Sleep on Metabolism

A study testing Inhibitory task, Blood samples and Tissue samples in people with Sleep Deprivation and Sleep, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study proposes to investigate whether acute total deprivation affects metabolism as measured through blood and peripheral tissues. Its aim is also to investigate how acute total sleep deprivation affects neurodegenerative markers, as well as hormones, memory performance and aspects of appetite regulation. Read more about this study

Who is it for?
Ages 18 to 28 years, men onlyHealthy volunteers can take part
Conditions the study is for
Sleep Deprivation, Sleep
What is being tested?
Inhibitory task, Blood samples and Tissue samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteSweden
Study dates
Mar 2013to Oct 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 28 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male
  • Age 18-28y
  • Healthy (self-reported) and not on medication
  • Non-smoking
  • Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported via diaries)

Who cannot join

  • Major illness
  • Taking any serious medications
  • Any sleep conditions (e.g. irregular bedtimes, sleep complaints)
  • Any dietary issues with the food items provided
  • Current or history of endocrine, neurological or psychiatric disorders
  • Shift work in the preceding three months or for a long duration
  • Time travel over a significant number of time zones in the preceding two months
  • Too much weight gain or weight loss in the preceding three months

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Neuroscience, Uppsala University

    Uppsala, Uppsala County, 75324

Other trials in Sweden

About this study

Official title: The Role of Acute Total Sleep Deprivation in the Regulation of Metabolism, Neuroendocrine Responses, and Behavioral Measures

The study proposes to investigate whether acute total deprivation affects metabolism as measured through blood and peripheral tissues. Its aim is also to investigate how acute total sleep deprivation affects neurodegenerative markers, as well as hormones, memory performance and aspects of appetite regulation.

Read the detailed description

It is predicted that acute total sleep deprivation will affect gene expression and DNA methylation. It is also predicted that sleep deprivation will up-regulate ghrelin, and affect other neuroendocrine markers and hormones in a negative manner. It is further predicted that sleep deprivation will decrease participants' memory performance.

Being tested
Inhibitory task, Blood samples, Tissue samples, Oral glucose tolerance test, Portion Size Task
Medical subject headings
Sleep Deprivation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhibitory taskBehavioural

    Participants perform a binary decision on each presented stimuli. Of the two possible outcomes, participants are instructed to make a motor response (go) for one type, and are to withhold a response (no-go) for the other type. Reaction time and accuracy are measured for each event

  • Blood samplesProcedure or surgery

    Hormone levels, neuromolecular levels and gene expression profiles will be analyzed from repeated blood samples obtained before and after the nighttime intervention

  • Tissue samplesProcedure or surgery

    Expression profiles will be analyzed from samples obtained from tissues involved in metabolism

  • Oral glucose tolerance testProcedure or surgery

    75 g of glucose will be dissolved in 300 ml of water and given to participants, followed by blood sampling at 0, 15, 30, 60, 90, 120 and 150 minutes following the ingestion of the glucose solution.

  • Portion Size TaskBehavioural

    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

Study groups in NCT01800253
Study groupRoleWhat they receive
Total sleep deprivationExperimentalParticipants will be required to stay up for the entire night before 'Blood Samples' and 'Tissue samples' will be taken and the 'Portion Size Task' and 'Inhibitory task' will be performed. This will then be followed by the 'Oral glucose tolerance test' with additional 'Blood Samples' to be taken as described for that test.
Receives: Behavioral: Inhibitory task; Procedure: Blood samples; Procedure: Tissue samples; Procedure: Oral glucose tolerance test; Behavioral: Portion Size Task
SleepExperimentalParticipants will have an 8-h sleep opportunity before 'Blood Samples' and 'Tissue samples' will be taken and 'Portion Size Task' and 'Inhibitory task' will be performed. This will be followed by the 'Oral glucose tolerance test' with additional 'Blood Samples' to be taken as described for that test.
Receives: Behavioral: Inhibitory task; Procedure: Blood samples; Procedure: Tissue samples; Procedure: Oral glucose tolerance test; Behavioral: Portion Size Task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gene expression and DNA methylation

    This study has been designed to measure the changes in gene expression and DNA methylation in circulating blood, i.e. mainly of white blood cells with active transcription and DNA regulation, and how this relates to possible changes in peripheral tissues involved in metabolism.

    Measured: Change from baseline (ie. around 1930 in the evening - before sleep intervention) to 12 hours later (around 0730 in the morning after the nighttime intervention), and to 15 hours later (around 1030 in the morning after the nighttime intervention)

Secondary outcomes (4)

  1. Circulating hormone and neuromolecular levels

    Participants will have their circulating hormone levels and neuromolecular levels taken and analyzed, including ghrelin, to determine if sleep deprivation alters hormone and neuromolecular levels related primarily to obesity, cognition or weight gain

    Measured: Change in circulating hormone levels from baseline (ie. around 1930 in the evening - before sleep intervention) to 12 hours later (around 0730 in the morning after the nighttime intervention)

  2. Appetitive evaluation

    Participants will be evaluated on their appetitive ratings in the morning following either nighttime intervention (acute total sleep deprivation or normal 8-hour sleep).

    Measured: Change in appetitive ratings after the sleep intervetion (from around 0700 in the morning after the nighttime intervention), repeated each hour

  3. Portion Size Task

    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 partial sleep deprivation and normal sleep, and changes before and after glucose ingestion will be compared between these conditions

    Measured: Change in selected portion size in the morning, at around 0830 hours in the morning following each nighttime intervention, and 2h30min later, i.e. 30 min after consuming an Oral glucose tolerance test, i.e. around 1100 hours

  4. Inhibitory task

    Participants perform a binary decision on each presented stimuli. Of the two possible outcomes, participants are instructed to make a motor response (go) for one type, and are to withhold a response (no-go) for the other type. Reaction time and accuracy are measured for each event.

    Measured: Change in cognitive inhibitory performance at around 0810 hours in the morning following the respective nighttime intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01800253
Sponsor's protocol ID
SleepMetaJCCB2013
Status last verified
Nov 2013
First submitted
21 Feb 2013
Last updated
9 Dec 2013
Results posted
No
Data monitoring committee
No

Publications

  • Zhang L, Grip A, Hjelmqvist D, Benedict C, Brandao LEM, Cedernaes J. Acute Sleep Loss Increases Circulating Morning Levels of Two MicroRNAs Implicated in Neurodegenerative Disease in Healthy Young Men. J Cell Mol Med. 2025 Apr;29(7):e70523. doi: 10.1111/jcmm.70523.

    PubMed 40194981

  • Mateus Brandao LE, Espes D, Westholm JO, Martikainen T, Westerlund N, Lampola L, Popa A, Vogel H, Schurmann A, Dickson SL, Benedict C, Cedernaes J. Acute sleep loss alters circulating fibroblast growth factor 21 levels in humans: A randomised crossover trial. J Sleep Res. 2022 Apr;31(2):e13472. doi: 10.1111/jsr.13472. Epub 2021 Sep 2.

    PubMed 34476847

  • Cedernaes J, Osler ME, Voisin S, Broman JE, Vogel H, Dickson SL, Zierath JR, Schioth HB, Benedict C. Acute Sleep Loss Induces Tissue-Specific Epigenetic and Transcriptional Alterations to Circadian Clock Genes in Men. J Clin Endocrinol Metab. 2015 Sep;100(9):E1255-61. doi: 10.1210/JC.2015-2284. Epub 2015 Jul 13.

    PubMed 26168277

Questions about this trial

What is this clinical trial studying?

A study testing Inhibitory task, Blood samples and Tissue samples in people with Sleep Deprivation and Sleep, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gene expression and DNA methylation (time frame: Change from baseline (ie. around 1930 in the evening - before sleep intervention) to 12 hours later (around 0730 in the morning after the nighttime intervention), and to 15 hours later (around 1030 in the morning after the nighttime intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01800253, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013.

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