NCT02000076

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

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

Study Start

First participant enrolled

November 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

August 13, 2013

Last Update Submit

May 13, 2016

Conditions

Keywords

Sleepresting statefunctional connectivityemotional contagionempathyemotional regulation

Outcome Measures

Primary Outcomes (1)

  • 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).

    Change between 1st and 2nd MRI scanning session (approx. 1 month later)

Study Arms (2)

Sleep deprivation

EXPERIMENTAL

Partial sleep deprivation allowing 3 h sleep at night

Behavioral: Partial sleep deprivation allowing 3 h sleep at night

Full sleep

EXPERIMENTAL

Sleep with no restriction

Behavioral: Full sleep

Interventions

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.

Also known as: Sleep restriction, Sleep loss
Sleep deprivation
Full sleepBEHAVIORAL

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 sleep

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet, Karolinska Universitetssjukhuset i Solna

Stockholm, None/Not Applicable, SE-17177, Sweden

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Sleep DeprivationEmotional Regulation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSelf-ControlSocial BehaviorBehavior

Study Officials

  • Torbjörn Åkerstedt, PhD

    Stockholm University

    STUDY CHAIR
  • Mats Lekander, PhD

    Stockholm University, Karolinska Institutet

    PRINCIPAL INVESTIGATOR
  • Håkan Fischer, PhD

    Stockholm University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 13, 2013

First Posted

December 3, 2013

Study Start

November 1, 2012

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

May 16, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

De-identified individual participant data will be shared through the openfmri.org data repository.

Locations