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

Primary Purpose

Sleep Deprivation

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Partial sleep deprivation allowing 3 h sleep at night

Full sleep

About this trial

This is an interventional basic science trial for Sleep Deprivation focused on measuring Sleep, resting state, functional connectivity, emotional contagion, empathy, emotional regulation

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Sites / Locations

Karolinska Institutet, Karolinska Universitetssjukhuset i Solna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sleep deprivation

Full sleep

Arm Description

Partial sleep deprivation allowing 3 h sleep at night

Sleep with no restriction

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT02000076

First Posted

August 13, 2013

Last Updated

May 13, 2016

Sponsor

Mats Lekander

Collaborators

Stockholm University

1. Study Identification

Unique Protocol Identification Number

NCT02000076

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mats Lekander

Collaborators

Stockholm University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Deprivation

Keywords

Sleep, resting state, functional connectivity, emotional contagion, empathy, emotional regulation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sleep deprivation

Arm Type

Experimental

Arm Description

Partial sleep deprivation allowing 3 h sleep at night

Arm Title

Full sleep

Arm Type

Experimental

Arm Description

Sleep with no restriction

Intervention Type

Behavioral

Intervention Name(s)

Partial sleep deprivation allowing 3 h sleep at night

Other Intervention Name(s)

Sleep restriction, Sleep loss

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Full sleep

Intervention Description

Primary Outcome Measure Information:

Title

Blood oxygen level-dependent response in amygdala to angry faces (t/z-score from statistical parametric mapping)

Description

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).

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Torbjörn Åkerstedt, PhD

Organizational Affiliation

Stockholm University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mats Lekander, PhD

Organizational Affiliation

Stockholm University, Karolinska Institutet

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Håkan Fischer, PhD

Organizational Affiliation

Stockholm University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska Institutet, Karolinska Universitetssjukhuset i Solna

City

Stockholm

State/Province

None/Not Applicable

ZIP/Postal Code

SE-17177

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

33087746

Citation

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.

Results Reference

derived

Links:

URL

https://osf.io/bxfsb/

Description

List of hypotheses

Learn more about this trial

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

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