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Completed

NCT Number: NCT03692962

Decision-making After Sleep Restriction

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sleep Restriction

Behavioral

Time in bed will be restricted to 5 hours per night for 7 nights.

Acoustic stimulation

Other

Brief tones will be presented time-locked to ongoing slow waves during deep sleep.

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. vigilance measures

    Time frame: before to after 7 nights of sleep restriction with and without acoustic stimulation

    Performance impairments in the psychomotor-vigilance task

  4. 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)

  5. 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.

  6. 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)

  7. 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)

  8. impulsivity

    Time frame: before to after 7 nights of sleep restriction with and without acoustic stimulation

    impulsivity as measured by an intertemporal choice Task.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Christian Baumann

Other

Collaborators

  • Swiss Federal Institute of Technology in Zurich (ETH Zurich)

Registry information

Official study title

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

Acronym: DM-SR

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2018
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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