- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02000076
The Stockholm Sleepy Brain Study: Effects of Sleep Deprivation on Cognitive and Emotional Processing in Young and Old
May 13, 2016 updated by: Mats Lekander
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
98
Phase
- 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
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None/Not Applicable
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Stockholm, None/Not Applicable, Sweden, SE-17177
- Karolinska Institutet, Karolinska Universitetssjukhuset i Solna
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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
Ages Eligible for Study
18 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
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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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sleep deprivation
Partial sleep deprivation allowing 3 h sleep at night
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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:
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Experimental: Full sleep
Sleep with no restriction
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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).
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Change between 1st and 2nd MRI scanning session (approx. 1 month later)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Torbjörn Åkerstedt, PhD, Stockholm University
- Principal Investigator: Mats Lekander, PhD, Stockholm University, Karolinska Institutet
- Principal Investigator: Håkan Fischer, PhD, Stockholm 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.
Helpful Links
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
November 1, 2012
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
August 13, 2013
First Submitted That Met QC Criteria
November 26, 2013
First Posted (Estimate)
December 3, 2013
Study Record Updates
Last Update Posted (Estimate)
May 16, 2016
Last Update Submitted That Met QC Criteria
May 13, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sleepy Brain Study Wave 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
De-identified individual participant data will be shared through the openfmri.org
data repository.
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.
Clinical Trials on Sleep Deprivation
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University of PennsylvaniaCompletedSleep Restriction Then Total Sleep Deprivation | Total Sleep Deprivation Then Sleep RestrictionUnited States
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Herlev HospitalTRYG Foundation; Danish Medical AssociationCompletedEffect of Sleep DeprivationDenmark
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Christian BaumannCompletedAcute and Partial Sleep DeprivationSwitzerland
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Dr. Osman HospitalCairo UniversityUnknownEffect of Insomnia and Sleep Deprivation in 3rdtrimesterEgypt
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Hallym University Medical CenterCompletedWe Investigated the Effect of Sleep Deprivation on the Tear Film and Ocular Surface.Korea, Republic of
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University of PittsburghNational Institute of Mental Health (NIMH)Not yet recruitingSleep | Sleep Disturbance | Insufficient SleepUnited States
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Children's Hospital of PhiladelphiaEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedSleep | Sleep Disturbance | Sleep DeprivationUnited States
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University of ChicagoCompleted
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Beth Israel Deaconess Medical CenterNational Institute of Mental Health (NIMH)Active, not recruiting
Clinical Trials on Partial sleep deprivation allowing 3 h sleep at night
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Zentrum für Integrative PsychiatrieGerman Research FoundationUnknownMajor DepressionGermany
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Direction Centrale du Service de Santé des ArméesRecruiting
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University of Sao PauloFundação de Amparo à Pesquisa do Estado de São Paulo; Conselho Nacional de...Completed
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University of California, Los AngelesCompleted
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Columbia UniversityNew York UniversityCompletedObesity | Sleep DeprivationUnited States
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Sheba Medical CenterInternational Diabetes FederationCompleted
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Medical University of South CarolinaTerminatedSuicidal Ideation | Bipolar Depression | Major Depressive DisorderUnited States
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Hospices Civils de LyonRecruitingPhysical Exercise | Motor LearningFrance
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Brigham and Women's HospitalActive, not recruitingSleep | Glucose Intolerance | Sleep DeprivationUnited States
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University of PittsburghCompletedDepressionUnited States