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The Stockholm Sleepy Brain Study: Effects of Sleep Deprivation on Cognitive and Emotional Processing in Young and Old

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02000076
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : May 16, 2016
Sponsor:
Collaborator:
Stockholm University
Information provided by (Responsible Party):
Mats Lekander, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE August 13, 2013
First Posted Date  ICMJE December 3, 2013
Last Update Posted Date May 16, 2016
Study Start Date  ICMJE November 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
Blood oxygen level-dependent response in amygdala to angry faces (t/z-score from statistical parametric mapping) [ Time Frame: Change between 1st and 2nd MRI scanning session (approx. 1 month later) ]
This registration is made in order to pre-specify hypotheses in a basic science project. For a full list of outcomes and hypotheses, see study description (above).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Stockholm Sleepy Brain Study: Effects of Sleep Deprivation on Cognitive and Emotional Processing in Young and Old
Official Title  ICMJE The Stockholm Sleepy Brain Study: Effects of Sleep Deprivation on Cognitive and Emotional Processing in Young and Old
Brief Summary The main purpose of this study is to investigate the effects of partial sleep deprivation (PSD) on resting state brain connectivity, emotional contagion, empathy, and emotional regulation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Sleep Deprivation
Intervention  ICMJE
  • Behavioral: Partial sleep deprivation allowing 3 h sleep at night
    Participants sleep at home while monitored with ambulatory polysomnography. For the full sleep condition, they are instructed to go to bed and to get up at the usual times that they would normally do that. For the sleep deprivation condition, they are instructed to go to bed 3 hours before the time when they would usually get up, and then to get up at that time.
    Other Names:
    • Sleep restriction
    • Sleep loss
  • Behavioral: Full sleep
    Participants sleep at home while monitored with ambulatory polysomnography. For the full sleep condition, they are instructed to go to bed and to get up at the usual times that they would normally do that. For the sleep deprivation condition, they are instructed to go to bed 3 hours before the time when they would usually get up, and then to get up at that time.
Study Arms  ICMJE
  • Experimental: Sleep deprivation
    Partial sleep deprivation allowing 3 h sleep at night
    Intervention: Behavioral: Partial sleep deprivation allowing 3 h sleep at night
  • Experimental: Full sleep
    Sleep with no restriction
    Intervention: Behavioral: Full sleep
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2015)
98
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2013)
30
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 20-30 years of age, inclusive OR 65-75 years of age, inclusive
  • Able to understand spoken and written Swedish (in order to understand instructions)
  • Normal or corrected-to-normal vision not using glasses
  • Not colour blind
  • Right-handed
  • Free from ferromagnetic objects in body
  • No history of any neurologic or psychiatric illness including drug abuse
  • No history of diabetes nor hypertension

    • No depression according to ratings using the Hospital Anxiety and Depression scale (HAD)
    • No insomnia according to ratings using the Insomnia Severity Index (ISI) and Karolinska Sleep Questionnaire (KSQ)
  • No use of psychotropic drugs
  • Not studying or working in medicine, psychology, nor behavioural science
  • Not suffering from severe seasonal allergy
  • No use of cortisone, anti-histamines, nor any other immune-modulating drugs
  • Habitual intake of no more than 4 cups of coffee per day or the equivalent in terms of caffeine
  • No daily use of nicotine

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02000076
Other Study ID Numbers  ICMJE Sleepy Brain Study Wave 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data will be shared through the openfmri.org data repository.
Responsible Party Mats Lekander, Karolinska Institutet
Study Sponsor  ICMJE Mats Lekander
Collaborators  ICMJE Stockholm University
Investigators  ICMJE
Study Chair: Torbjörn Åkerstedt, PhD Stockholm University
Principal Investigator: Mats Lekander, PhD Stockholm University, Karolinska Institutet
Principal Investigator: Håkan Fischer, PhD Stockholm University
PRS Account Karolinska Institutet
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP