NCT01823263

Brief Summary

The purpose of this study is to determine whether partial sleep deprivation, as compared with normal sleep, influences certain metabolic and cognitive parameters, related to food intake, hunger and memory functions, when participants are shielded from external time cues.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

February 21, 2013

Last Update Submit

November 27, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Memory tasks

    Procedural memory performance after learning a procedural memory task close to going to bed, followed by either partial sleep deprivation (PSD) or normal sleep (NS), and comparing the performance the following morning at two time points. Participants spatial memory performance in the morning at two time points, following PSD will also be compared with that following NS, after having learned such a memory task in the evening before going to bed.

    Change in memory performance between learning (at 2230 hours in NS and PSD condition) before going to sleep, and at 0800 and 0930 hours (following PSD or NS)

Secondary Outcomes (4)

  • Circulating hormone levels

    Change in circulating hormone levels and other metabolism-linked and neurodegeneration-associated molecules at 0730, 0830, 0910, 0925, 0940, 1010, 1040, 1105, and 1150 hours following the respective nighttime intervention and after the interference task

  • Intake task

    Change in intake at around 1200 hours, following the respective nighttime intervention (NS or PSD)

  • Working memory function task

    Change in memory performance at 0800 hours and after the interference task again at 0930 hours (between and following PSD or NS)

  • Portion Size Task

    Change in selected portion size from baseline (at 0800 hours following the nighttime intervention), to one hour later, i.e. after an interference task

Study Arms (2)

Partial sleep deprivation

EXPERIMENTAL

Partial sleep deprivation: participants will have a 4-h sleep opportunity before a 'Blood Sample' will be taken, and the 'Memory tasks', 'Working memory function task' and 'Portion size task' will be performed. This will be followed by an 'Interference task', followed by repeated blood sampling and an 'Intake task'.

Behavioral: Portion Size TaskProcedure: Blood sampleProcedure: Interference taskBehavioral: Memory tasksBehavioral: Intake taskBehavioral: Working memory function task

Normal sleep

EXPERIMENTAL

Normal sleep: participants will have an 8-h sleep opportunity before a 'Blood Sample' will be taken, and the 'Memory tasks', 'Working memory function task' and 'Portion size task' will be performed. This will be followed by an 'Interference task', followed with repeated blood sampling and an 'Intake task'.

Behavioral: Portion Size TaskProcedure: Blood sampleProcedure: Interference taskBehavioral: Memory tasksBehavioral: Intake taskBehavioral: Working memory function task

Interventions

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

Normal sleepPartial sleep deprivation
Blood samplePROCEDURE

In the morning following partial sleep deprivation or normal sleep, a blood sample will be taken to assess the level of metabolism-linked and neurodegenerative-linked molecules, as well as to assay blood serum and plasma for the presence of hormones involved in hunger such as ghrelin

Normal sleepPartial sleep deprivation

30-minute interference task

Normal sleepPartial sleep deprivation
Memory tasksBEHAVIORAL

Participants will be allowed to learn a procedural memory task before going to bed. Participants will be retested in the morning to assess their change in performance. Other memory tests will also be given to assess the working memory performance in the morning following the intervention.

Normal sleepPartial sleep deprivation
Intake taskBEHAVIORAL

After a normal night of sleep or partial sleep deprivation, participants are presented with an ad libitum meal choice and can select the amount to ingest during a limited time window. Amount and selection will be recorded

Normal sleepPartial sleep deprivation

Participants will be evaluated on their working memory performance in the morning following either nighttime intervention (NS or PSD)

Normal sleepPartial sleep deprivation

Eligibility Criteria

Age20 Years - 28 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Age 20-28y
  • Healthy (self-reported) and not on medication
  • Non-smoking
  • Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported and verified by sleep diaries)
  • Normal dietary habits (regular meal pattern with daily breakfast)

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
  • A history of endocrine, neurological or psychiatric disorders
  • Shift work in the previous 3 months
  • Travel over several time zones within the previous two months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuroscience, Uppsala University

Uppsala, Uppsala County, 75105, Sweden

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Blood Specimen Collection

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 Techniques

Study Officials

  • Christian Benedict, PhD

    Department of Neuroscience, Uppsala University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Cedernaes, M.D., PhD

CONTACT

Christian Benedict, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

April 4, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations