The Stockholm Sleepy Brain Study: Effec… | Clinical Trial

Key information

Conditions

Sleep Deprivation Behavior Dyssomnias Emotional Regulation Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Self-Control Signs and Symptoms Sleep Wake Disorders Social Behavior

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Karolinska Universitetssjukhuset i Solna

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Partial sleep deprivation allowing 3 h sleep at night

Behavioral

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: Sleep restriction, Sleep loss

Full sleep

Behavioral

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.

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Mats Lekander

Other

Collaborators

Stockholm University

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Dec 3, 2013
Registry last updated: May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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