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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02000076
Other study ID # Sleepy Brain Study Wave 1
Secondary ID
Status Completed
Phase N/A
First received August 13, 2013
Last updated May 13, 2016
Start date November 2012
Est. completion date May 2014

Study information

Verified date May 2016
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date May 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 75 Years
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Sweden Karolinska Institutet, Karolinska Universitetssjukhuset i Solna Stockholm None/Not Applicable

Sponsors (2)

Lead Sponsor Collaborator
Mats Lekander Stockholm University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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