Sleep DeprivationNCT02000076

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

A study testing Partial sleep deprivation allowing 3 h sleep at night and Full sleep in people with Sleep Deprivation, run by Mats Lekander 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

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 20 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Sleep Deprivation
What is being tested?: Partial sleep deprivation allowing 3 h sleep at night and Full sleep
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 1 siteSweden
Study dates: Nov 2012to May 2014
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 20 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 16Show fewer

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

Who cannot join

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Karolinska Institutet, Karolinska Universitetssjukhuset i Solna
Stockholm, None/Not Applicable, SE-17177

Other trials in Sweden

About this study

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.

Conditions: Sleep Deprivation
Being tested: Partial sleep deprivation allowing 3 h sleep at night, Full sleep
Keywords: Sleep, resting state, functional connectivity, emotional contagion, empathy, emotional regulation
Medical subject headings: Sleep Deprivation, Emotional Regulation

What participants receive

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

Partial sleep deprivation allowing 3 h sleep at nightBehavioural
Also called Sleep restriction, Sleep loss
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.
Full sleepBehavioural
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 groups in NCT02000076
Study group	Role	What they receive
Sleep deprivation	Experimental	Partial sleep deprivation allowing 3 h sleep at night Receives: Behavioral: Partial sleep deprivation allowing 3 h sleep at night
Full sleep	Experimental	Sleep with no restriction Receives: Behavioral: Full sleep

What is being measured

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

Blood oxygen level-dependent response in amygdala to angry faces (t/z-score from statistical parametric mapping)
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).
Measured: Change between 1st and 2nd MRI scanning session (approx. 1 month later)

Timeline

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

Nov 2012May 2014

First posted3 Dec 2013 (estimated)
Study startNov 2012
Primary completionMar 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Sleep DeprivationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Single blind
Who is masked: Investigator
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02000076
Sponsor's protocol ID: Sleepy Brain Study Wave 1
Status last verified: May 2016
First submitted: 13 Aug 2013
Last updated: 16 May 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual participant data will be shared through the openfmri.org data repository.

Publications

Tian Y, Peng XR, Tang Z, Long Z, Xie C, Lei X. Enhanced diversity on connector hubs following sleep deprivation: Evidence from diffusion and functional magnetic resonance imaging. Neuroimage. 2024 Oct 1;299:120837. doi: 10.1016/j.neuroimage.2024.120837. Epub 2024 Sep 4.
PubMed 39241898
Tamm S, Schwarz J, Thune H, Kecklund G, Petrovic P, Akerstedt T, Fischer H, Lekander M, Nilsonne G. A combined fMRI and EMG study of emotional contagion following partial sleep deprivation in young and older humans. Sci Rep. 2020 Oct 21;10(1):17944. doi: 10.1038/s41598-020-74489-9.
PubMed 33087746

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
Recruiting
The Function of Biphasic Sleep in Infants
Sleep Deprivation
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm

All Sleep Deprivation trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Stockholm Sleepy Brain Study: Effects of Sleep Deprivation on Cognitive and Emotional Processing in Young and Old
ClinicalTrials.gov ID: NCT02000076
Acronym / sponsor ID: Sleepy Brain Study Wave 1
Conditions: Sleep Deprivation
Keywords: Sleep, resting state, functional connectivity, emotional contagion, empathy, emotional regulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Mats LekanderUniversity, hospital or other
Collaborators: Stockholm University
Study start: Nov 2012
Primary completion: Mar 2014 (actual)
Study completion: May 2014 (actual)
First posted: 3 Dec 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Sleep deprivation	Experimental	Behavioral: Partial sleep deprivation allowing 3 h sleep at nightPartial sleep deprivation allowing 3 h sleep at night
Full sleep	Experimental	Behavioral: Full sleepSleep with no restriction

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Partial sleep deprivation allowing 3 h sleep at nightAlso: Sleep restriction, Sleep lossParticipants 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.	Behavioural	Sleep deprivation
Full sleepParticipants 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.	Behavioural	Full sleep

Primary outcome

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).

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
Derived from this study: PubMed 39241898Tian Y, Peng XR, Tang Z, Long Z, Xie C, Lei X. Enhanced diversity on connector hubs following sleep deprivation: Evidence from diffusion and functional magnetic resonance imaging. Neuroimage. 2024 Oct 1;299:120837. doi: 10.1016/j.neuroimage.2024.120837. Epub 2024 Sep 4.
Derived from this study: PubMed 33087746Tamm S, Schwarz J, Thune H, Kecklund G, Petrovic P, Akerstedt T, Fischer H, Lekander M, Nilsonne G. A combined fMRI and EMG study of emotional contagion following partial sleep deprivation in young and older humans. Sci Rep. 2020 Oct 21;10(1):17944. doi: 10.1038/s41598-020-74489-9.
List of hypothesesLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared through the openfmri.org data repository.

Related trials for Sleep Deprivation

Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
Recruiting
The Function of Biphasic Sleep in Infants
Sleep Deprivation
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Torbjörn Åkerstedt, PhD study chair

Stockholm University

Mats Lekander, PhD principal investigator

Stockholm University, Karolinska Institutet

Håkan Fischer, PhD principal investigator

Stockholm University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Partial sleep deprivation allowing 3 h sleep at night and Full sleep in people with Sleep Deprivation, run by Mats Lekander 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 16 inclusion and 1 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 16 May 2016. 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?

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)). 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 NCT02000076, which also lists 2 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 16 May 2016.