Clinical trial NCT03692962: Decision-making After Sleep Restriction
Official title: Linking the Change in Decision-making After Sleep Restriction to the Restorative Function of Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Restriction
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology in Zurich (ETH Zurich)
First posted: 2018-10-02
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: risk-premium
timeFrame: 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 outcomes:
measure: high-density electroencephalography (hdEEG) marker of sleep pressure
timeFrame: assessed during first and last sleep restriction nights in comparison to baseline values
measure: brain metabolites
timeFrame: before to after 7 nights of sleep restriction with and without acoustic stimulation
measure: vigilance measures
timeFrame: before to after 7 nights of sleep restriction with and without acoustic stimulation
measure: deception willingness
timeFrame: before to after 7 nights of sleep restriction with and without acoustic stimulation
measure: Motor inhibitory control performance
timeFrame: before to after 7 nights of sleep restriction with and without acoustic stimulation
measure: confidence
timeFrame: before to after 7 nights of sleep restriction with and without acoustic stimulation
measure: overconfidence
timeFrame: before to after 7 nights of sleep restriction with and without acoustic stimulation
measure: impulsivity
timeFrame: before to after 7 nights of sleep restriction with and without acoustic stimulation
measure: Ocular inhibitory control performance
timeFrame: before to after 7 nights of sleep restriction with and without acoustic stimulation
measure: Effort in inhibitory control performance
timeFrame: before to after 7 nights of sleep restriction with and without acoustic stimulation
measure: Excessive daytime sleepiness
timeFrame: before to after 7 nights of sleep restriction with and without acoustic stimulation
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: Zurich
Study officials:
References: