- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07822009
The Neurocognitive Effects of Total and Partial Sleep Deprivation in Younger Adults.
The Effect of Total and Partial Sleep Deprivation on Brain Function and Cognitive Functioning In Healthy, Younger Adults.
This study aims to examine how total and partial sleep deprivation affect brain function, cognitive performance, and biomarkers related to stress and inflammation in the same participants using a crossover design. The study will also compare the effects of total and partial sleep deprivation to determine whether these conditions affect the brain and body differently. The findings may improve our understanding of the consequences of sleep deprivation and help inform strategies to reduce its negative impact on health and society.
- How does total versus partial sleep deprivation affect brain activity during rest and cognitive tasks?
- How does sleep deprivation affect functional connectivity between brain networks?
- How does sleep deprivation affect working memory, attention, and executive control?
- How does sleep deprivation affect biomarkers of stress and inflammation, such as cortisol?
- Are changes in brain activity and connectivity associated with changes in cognitive performance and biological markers?
- Can combining MRI-based and non-MRI-based measures provide a more complete picture of the effects of sleep deprivation?
Participants will complete three study conditions in a randomized order:
Total Sleep Deprivation (TSD): 28 to 32 hours of continuous wakefulness. Partial Sleep Deprivation (PSD): sleep restricted to 4 hours per night for two consecutive nights.
Normal Sleep (control condition): a night of habitual sleep without sleep restriction.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Örebro County
-
Örebro, Örebro County, Sweden, 70182
- Örebro university
-
Contact:
- Pernilla Andersson
- Phone Number: 019 30 30 00
- Email: naps@oru.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Signed informed consent prior to any study-related procedures.
- Age 20 to 40 years.
- Normal weight at screening, defined as a BMI between 18.5 and 24.9.
- Willingness to comply with the study protocol.
Exclusion Criteria:
- Current diagnosis of a psychiatric or neurological disorder or syndrome.
- Current diagnosis of another medical condition that limits study participation.
- Diagnosed sleep disorder (e.g., insomnia).
- Self-reported poor sleep quality (>5 on the PSQI).
- Working permanent night shifts or rotating night shifts.
- Use of medications or dietary supplements considered likely to affect the study outcome measures (e.g., melatonin).
- Extremely high perceived stress (>26 on the PSS).
- Sleep apnea.
- Excessive alcohol consumption (>9 standard drinks per week or >3 standard drinks per occasion).
- Extreme morningness or eveningness (>69 or <31 on the MEQ).
- Excessive daytime sleepiness (>10 on the ESS).
- Lifestyle factors that may contribute to fragmented sleep (e.g., being a parent of young children).
- MRI contraindications: claustrophobia; shunts in the head; bullet fragments or metal fragments in the body; metal implants or electrodes in the body; left-handedness; previous head surgery; previous heart surgery; or ingestion of a video capsule that may remain in the gastrointestinal tract.
- Any other reason that, in the opinion of the investigator, makes participation inappropriate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Normal sleep
|
Normal (7-9 hours) sleep, following normal patterns of wakeup and sleep onset.
|
|
Other: Total Sleep Deprivation
|
No sleep for 28-32 hours.
|
|
Other: Partial Sleep Deprivation
|
Restriction to 4 hours sleep/night for two consecutive nights.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain functional activity and connectivity (PVT)
Time Frame: 3 weeks
|
Compare normal sleep to SD (total and partial)
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain functional activity and connectivity (PVT) - SD
Time Frame: 3 weeks
|
Compare total sleep deprivation and partial sleep deprivation.
|
3 weeks
|
|
Brain functional activity and connectivity (NBACK)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Brain functional activity and connectivity (MST)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Brain functional activity and connectivity (SST)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Brain functional activity and connectivity (EMOREG)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Resting state fMRI
Time Frame: 3 weeks
|
Total SD vs Partial SD
|
3 weeks
|
|
Structural MRI
Time Frame: 3 weeks
|
Total SD vs. Partial SD
|
3 weeks
|
|
Diffusion tensor imaging
Time Frame: 3 weeks
|
Total SD vs Partial SD
|
3 weeks
|
|
Cognitive function (NBACK)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Cognitive function (MST)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Cognitive function (SST)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Cognitive function (EMOREG)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Levels of inflammatory markers (e.g. high sensitivity C-reactive protein (hsCRP), interleukin (IL)-6, tumor necrosis factor (TNF)-alpha)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Levels of neural function markers (e.g. brain derived neurotrophic factor (BDNF)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Salivary biomarkers (e.g., melatonin and cortisol)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Electrophysiological measures (e.g., ECG)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Assessment of psychological health using Hospital Anxiety and Depression Scale (HADS)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Assessment of psychological health using Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Assessment of psychological health using Perceived Stress Scale (PSS)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Assessment of subjective sleepiness using the Karolinska Sleepiness Scale (KSS)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Assessment of sleep quality and sleep disturbances using the Karolinska Sleep Questionnaire (KSQ)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Assessment of daytime sleepiness using the Epworth Sleepiness Scale (ESS)
Time Frame: 3 weeks
|
3 weeks
|
|
|
Assessment of chronotype (morningness-eveningness preference) using the Reduced Morningness-Eveningness Questionnaire (rMEQ)
Time Frame: 1
|
1
|
|
|
Assessment of sleep-related positive and negative affect using the Negative and Positive Affect Scale for Sleep (NAP-AS)
Time Frame: 3 weeks
|
3 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Faecal samples for evaluation of gut microbiota composition
Time Frame: 1 day
|
1 day
|
|
Levels of neural function markers (e.g. S100B)
Time Frame: 3 weeks
|
3 weeks
|
|
Physical activity assessed using actigraphy
Time Frame: 3 weeks
|
3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr: 2026-03064-01
- 20230004-H-01 (Other Grant/Funding Number: The Knowledge Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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