- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03692962
Decision-making After Sleep Restriction (DM-SR)
February 10, 2021 updated by: Christian Baumann
Linking the Change in Decision-making After Sleep Restriction to the Restorative Function of Sleep
The aim of this project is to investigate whether enhancing sleep intensity locally in the prefrontal cortex (PFC) can counteract a deterioration of cognitive control and therefore the previously described increase in risk seeking during chronic sleep restriction.
To this end, a controlled, counter-balanced study, consisting of two weeks of sleep restriction will be performed.
During one of the sleep restriction weeks, sleep intensity in the PFC will be non-invasively enhanced by acoustic stimulation of slow waves during sleep.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zurich
-
Zürich, Zurich, Switzerland, 8091
- University Hospital Zurich
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Age between 18-21 years or 26-30 years,
- Right-handedness,
- Good general health,
- Good understanding of German language (as all information is provided in German)
- Signed Informed Consent after being informed.
Exclusion Criteria:
- Contraindications on ethical grounds,
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
- Known or suspected non-compliance, drug or alcohol abuse (> 5dl wine/ >1l beer daily),
- Regular medication intake,
- Enrolment into a clinical trial within last 4 weeks,
- Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases),
- Sleep disorders (e.g. Insomnia, sleep apnoea, restless leg syndrome, narcolepsy, etc.),
- Sleep complaints in general or excessive daytime sleepiness (Pittsburgh Sleep Quality Index > 5; Epworth Sleepiness Scale ≥ 11),
- Irregular sleep-wake rhythm (e.g. shift working),
- Long (> 10 hours per night) or short sleepers (< 7 hours per night),
- Sleep efficiency < 80% in screening night,
- Travelling with time lag less than 1 month ago (or planning to do so within 1 month prior to or during the study),
- > 5 drinks or food items containing caffeine per day,
- > 5 cigarettes per day,
- Body Mass Index < 19 or > 30 kg/m2,
- Skin allergy or very sensitive skin
- Student of one of the following subjects: Mathematics, Physics, Computer Science, Economics, or Psychology (since students of these subjects have profound knowledge of probability calculations, which could interfere with our measurements in decision-making).
- Red-Green Colour-Blindness (as the Risk Task requires the distinction between red and green),
- History of claustrophobia,
- Known hearing disorder (as acoustic stimuli will be applied during sleep),
- Magnetic Resonance (MR) contraindication (such as pacemaker, implanted pumps, shrapnel, etc.; full MR Screening form will be filled out).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Sleep restriction without acoustic stimulation
|
Time in bed will be restricted to 5 hours per night for 7 nights.
|
Experimental: Sleep restriction with acoustic stimulation
|
Time in bed will be restricted to 5 hours per night for 7 nights.
Brief tones will be presented time-locked to ongoing slow waves during deep sleep.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
risk-premium
Time Frame: comparison of change from baseline after 7 nights of sleep restriction with acoustic stimulation to change from baseline after 7 nights of sleep restriction without acoustic stimulation
|
risk-preference (i.e.
risk premium assessed with the risk Task as described in Maric et al. 2017 Ann Neurol) after chronic sleep restriction with and without acoustic Stimulation will be quantified by the risk-premium derived from the choices made in the risk-task as described in Maric et al. 2017 Ann Neurol.
|
comparison of change from baseline after 7 nights of sleep restriction with acoustic stimulation to change from baseline after 7 nights of sleep restriction without acoustic stimulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
high-density electroencephalography (hdEEG) marker of sleep pressure
Time Frame: assessed during first and last sleep restriction nights in comparison to baseline values
|
Slow wave activity (SWA) assessed by hd-EEG with 128 electrodes
|
assessed during first and last sleep restriction nights in comparison to baseline values
|
brain metabolites
Time Frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
|
Glutamate and gamma-aminobutyric acid (GABA) concentration in the right prefrontal Cortex assessed by magnetic resonance (MR) spectroscopy
|
before to after 7 nights of sleep restriction with and without acoustic stimulation
|
vigilance measures
Time Frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
|
Performance impairments in the psychomotor-vigilance task
|
before to after 7 nights of sleep restriction with and without acoustic stimulation
|
deception willingness
Time Frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
|
deception willingness measured by the willingness to deception of outcome in a card game with binary outcome (win and loss)
|
before to after 7 nights of sleep restriction with and without acoustic stimulation
|
Motor inhibitory control performance
Time Frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
|
inhibitory control performance measured by the stop-signal-task.
|
before to after 7 nights of sleep restriction with and without acoustic stimulation
|
confidence
Time Frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
|
overconfidence measured by an incentivised procedure that elicits the certainity equivalent of a bet based on Performance in a quiz (cf.
Murad et al. 2016 J Risk Uncertain)
|
before to after 7 nights of sleep restriction with and without acoustic stimulation
|
overconfidence
Time Frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
|
overconfidence measured by an incentivised procedure that elicits the certainity equivalent of a bet based on Performance in a quiz (cf.
Murad et al. 2016 J Risk Uncertain)
|
before to after 7 nights of sleep restriction with and without acoustic stimulation
|
impulsivity
Time Frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
|
impulsivity as measured by an intertemporal choice Task.
|
before to after 7 nights of sleep restriction with and without acoustic stimulation
|
Ocular inhibitory control performance
Time Frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
|
Ocular inhibitory control Performance measured by the Anti-Saccade Task.
|
before to after 7 nights of sleep restriction with and without acoustic stimulation
|
Effort in inhibitory control performance
Time Frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
|
Pupil response (i.e.
dilation) during a simple Go/No-Go Task.
|
before to after 7 nights of sleep restriction with and without acoustic stimulation
|
Excessive daytime sleepiness
Time Frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
|
Excessive daytime sleepiness assessed by the Epworth sleepiness scale and the Stanford Sleepiness Scale.
|
before to after 7 nights of sleep restriction with and without acoustic stimulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Actual)
October 12, 2020
Study Completion (Actual)
November 2, 2020
Study Registration Dates
First Submitted
June 4, 2018
First Submitted That Met QC Criteria
October 1, 2018
First Posted (Actual)
October 2, 2018
Study Record Updates
Last Update Posted (Actual)
February 11, 2021
Last Update Submitted That Met QC Criteria
February 10, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- DM-SR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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