Clinical trial NCT02305225: Cortical Excitability and Decision Making After Total Sleep Deprivation and Sleep Restriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute and Partial Sleep Deprivation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators examine changes in decision making, vigilance and cortical excitability in healthy male subjects undergoing total acute sleep deprivation (40 hours) on the one hand, and chronic partial sleep restriction (7 nights with 5 instead of 8 hours in bed per night) on the other hand, in a cross over controlled manner. The investigators hypothesize that total sleep deprivation, as well as partial sleep restriction lead to impairments in decision making and vigilance, and enhanced cortical excitability.

Beside these three primary outcomes, the investigators also assess changes in sleep by EEG, dim light melatonin onset, skin temperature, subjective mood and sleepiness, working memory, and also collect saliva samples.


Eligibility criteria: Inclusion Criteria:

* Male (in female subjects, menstrual cycle influences sleep)
* Age between 18-35 years
* Right-handedness
* Good general health
* 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
* History of seizure or a family history of epilepsy
* Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases)
* History of any moderate or heavy head trauma
* Sleep disorders (e.g. Insomnia, sleep apnea, restless leg syndrome, narcolepsy, etc.)
* Sleep complaints in general or EDS
* Irregular sleep-wake rhythm (e.g. shift working)
* Long (\> 9 hours per night) or short sleepers (\< 7hours per night)
* Sleep efficiency ≤ 80%
* Travelling with time lag less than 1 month ago (or planning to do so within 1 month prior to the study)
* Body Mass Index \< 19 or \> 30 kg/m2

  * 5 drinks or food items containing caffeine per day
  * 10 cigarettes per day
* 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)
* The following additional exclusion criteria apply only to subjects with TMS sessions
* History of frequent and/or heavy headache respectively migraine
* History of claustrophobia
* Hearing disorder
* Magnetic Resonance Imaging (MRI) contraindication (such as pacemaker implanted pumps, shrapnel, etc.; full MRI screening form will be filled out - see -Entrance questionnaires)
* No clear TMS evoked potential in the target area during the screening assessment
* These subjects will be invited to participate in the study with no TMS sessions, the other protocol being identical

Primary outcomes:
measure: Change in cortical excitability after Chronic Sleep Deprivation as measured by TMS evoked responses in the EEG
timeFrame: Change from Baseline to after 7 nights of chronic Sleep Deprivation
measure: Change in Reaction Times after Chronic Sleep Deprivation as measured by the Psychomotor Vigilance Task
timeFrame: Change from Baseline to after 7 nights of chronic Sleep Deprivation
measure: Change in risk taking and financial impulsivity as measured by the Amount of risky options chosen in the risk task and the amount of financial impulsive choices in the Delay Discount Task
timeFrame: Change from Baseline to after 7 nights of chronic Sleep Deprivation
Secondary outcomes:
measure: Slow Wave Activity during Sleep as measured by the power in the EEG in the frequency range of 1-4.5 Hz
timeFrame: Baseline, 1st Recovery Night of total Sleep Deprivation, 5th, 6th, 7th night of partial Sleep Deprivation, 1st Recovery Night from partial Sleep Deprivation
measure: Dim Light Melatonin Onset as measured by the melatonin concentration in hourly collected saliva samples
timeFrame: Baseline, 1st evening after partial Sleep Deprivation, 7th to 14th evening after partial Sleep Deprivation
measure: Skin Temperature profiles as measured by skin temperature sensors (Celsius)
timeFrame: from 1 week prior to partial Sleep Deprivation to 8-14 days after
measure: Mood ratings as measured by a visual analog scale
timeFrame: 2 Baseline Days (prior to both parts), 1st Day of total Sleep Deprivation, 1st Day of Recovery from total Sleep Deprivation, 6th, 7th & 8th Day of partial Sleep Deprivation, 8th to 14th Day of Recovery from partial Sleep Deprivation
measure: subjective sleepines as measured by the stanford sleepiness scale
timeFrame: 2 Baseline Days (prior to both parts), 1st Day of total Sleep Deprivation, 1st Day of Recovery from total Sleep Deprivation, 6th, 7th & 8th Day of partial Sleep Deprivation, 8th to 14th Day of Recovery from partial Sleep Deprivation
measure: Working Memory performance as measured by errors of comission and omission the n-back Task
timeFrame: 2 Baseline Days (prior to both parts), 1st Day of total Sleep Deprivation, 1st Day of Recovery from total Sleep Deprivation, 6th, 7th & 8th Day of partial Sleep Deprivation, 8th to 14th Day of Recovery from partial Sleep Deprivation
measure: metabolic profile as measured by metabolites in saliva
timeFrame: Baseline Day 1, 1st Day of total Sleep Deprivation, 8th Day of partial Sleep Deprivation
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Neurology
state: ZH
Study officials:
References: