Decision-making After Sleep Restriction

Sleep Restriction Clinical Trial

— DM-SR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692962
• Other study ID #: DM-SR
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: November 2, 2020

Study information

• Verified date: February 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2, 2020
• Est. primary completion date: October 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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).

Related Conditions & MeSH terms

• Sleep Restriction

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Christian Baumann	Swiss Federal Institute of Technology in Zurich (ETH Zurich)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	risk-premium	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	high-density electroencephalography (hdEEG) marker of sleep pressure	Slow wave activity (SWA) assessed by hd-EEG with 128 electrodes	assessed during first and last sleep restriction nights in comparison to baseline values
Secondary	brain metabolites	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
Secondary	vigilance measures	Performance impairments in the psychomotor-vigilance task	before to after 7 nights of sleep restriction with and without acoustic stimulation
Secondary	deception willingness	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
Secondary	Motor inhibitory control performance	inhibitory control performance measured by the stop-signal-task.	before to after 7 nights of sleep restriction with and without acoustic stimulation
Secondary	confidence	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
Secondary	overconfidence	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
Secondary	impulsivity	impulsivity as measured by an intertemporal choice Task.	before to after 7 nights of sleep restriction with and without acoustic stimulation
Secondary	Ocular inhibitory control performance	Ocular inhibitory control Performance measured by the Anti-Saccade Task.	before to after 7 nights of sleep restriction with and without acoustic stimulation
Secondary	Effort in inhibitory control performance	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
Secondary	Excessive daytime sleepiness	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