Decision-making After Sleep Restriction

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Christian Baumann，University of Zurich

Tracking Information

First Submitted Date ^ICMJE

June 4, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

September 1, 2018

Estimated Primary Completion Date

September 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

high-density electroencephalography (hdEEG) marker of sleep pressure[ Time Frame: assessed during all sleep restriction nights in comparison to baseline values ]
Slow wave activity (SWA) assessed by hd-EEG with 128 electrodes
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
vigilance measures[ Time Frame: before to after 7 nights of sleep restriction with and without acoustic stimulation ]
Performance impairments in the psychomotor-vigilance task
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)
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.
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)
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)
impulsivity[ Time Frame: before to after 7 nights of sleep restriction with and without acoustic stimulation ]
impulsivity as measured by an intertemporal choice Task.
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.
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.
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.

Descriptive Information

Brief Title ^ICMJE

Decision-making After Sleep Restriction

Official Title ^ICMJE

Linking the Change in Decision-making After Sleep Restriction to the Restorative Function of Sleep

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Basic Science

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: Sleep restriction
Time in bed will be restricted to 5 hours per night for 7 nights.
Other: Acoustic stimulation
Brief tones will be presented time-locked to ongoing slow waves during deep sleep.

Study Arms

Sham Comparator: Sleep restriction without acoustic stimulation
Experimental: Sleep restriction with acoustic stimulation

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 2021

Estimated Primary Completion Date

September 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Switzerland

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Christian Baumann，University of Zurich

Study Sponsor ^ICMJE

Christian Baumann

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

University of Zurich

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名