NCT01800253

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 9, 2013

Status Verified

November 1, 2013

Enrollment Period

7 months

First QC Date

February 21, 2013

Last Update Submit

December 6, 2013

Conditions

Outcome Measures

Primary Outcomes (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.

    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)

  • Circulating hormone and neuromolecular levels

    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)

  • Appetitive evaluation

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

  • Portion Size Task

    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

  • Inhibitory task

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

Study Arms (2)

Total sleep deprivation

EXPERIMENTAL

Participants 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.

Behavioral: Inhibitory taskProcedure: Blood samplesProcedure: Tissue samplesProcedure: Oral glucose tolerance testBehavioral: Portion Size Task

Sleep

EXPERIMENTAL

Participants 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.

Behavioral: Inhibitory taskProcedure: Blood samplesProcedure: Tissue samplesProcedure: Oral glucose tolerance testBehavioral: Portion Size Task

Interventions

Inhibitory taskBEHAVIORAL

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

SleepTotal sleep deprivation
Blood samplesPROCEDURE

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

SleepTotal sleep deprivation

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

SleepTotal sleep deprivation

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.

SleepTotal sleep deprivation

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

SleepTotal sleep deprivation

Eligibility Criteria

Age18 Years - 28 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuroscience, Uppsala University

Uppsala, Uppsala County, 75324, Sweden

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Blood Specimen CollectionGlucose Tolerance Test

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesBlood Chemical AnalysisClinical Chemistry TestsDiagnostic Techniques, Endocrine

Study Officials

  • Christian Benedict, PhD

    Department of Neuroscience, Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 27, 2013

Study Start

March 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

December 9, 2013

Record last verified: 2013-11

Locations