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Clinical Trials/NCT03692962
NCT03692962
Completed
Not Applicable

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

Christian Baumann1 site in 1 country28 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Restriction
Sponsor
Christian Baumann
Enrollment
28
Locations
1
Primary Endpoint
risk-premium
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
November 2, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Christian Baumann

Prof. Dr. med.

University of Zurich

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),

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • confidence(before to after 7 nights of sleep restriction with and without acoustic stimulation)
  • high-density electroencephalography (hdEEG) marker of sleep pressure(assessed during first and last sleep restriction nights in comparison to baseline values)
  • brain metabolites(before to after 7 nights of sleep restriction with and without acoustic stimulation)
  • impulsivity(before to after 7 nights of sleep restriction with and without acoustic stimulation)
  • Effort in inhibitory control performance(before to after 7 nights of sleep restriction with and without acoustic stimulation)
  • vigilance measures(before to after 7 nights of sleep restriction with and without acoustic stimulation)
  • overconfidence(before to after 7 nights of sleep restriction with and without acoustic stimulation)
  • Ocular inhibitory control performance(before to after 7 nights of sleep restriction with and without acoustic stimulation)
  • Excessive daytime sleepiness(before to after 7 nights of sleep restriction with and without acoustic stimulation)
  • deception willingness(before to after 7 nights of sleep restriction with and without acoustic stimulation)
  • Motor inhibitory control performance(before to after 7 nights of sleep restriction with and without acoustic stimulation)

Study Sites (1)

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