Cortical Excitability and Decision Making After Total Sleep Deprivation and Sleep Restriction

NCT02305225 | Completed

• 1 other identifier: 2012-0496
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute and Partial Sleep Deprivation

Outcome Measures

Primary Outcomes (3)

• Change in cortical excitability after Chronic Sleep Deprivation as measured by TMS evoked responses in the EEG

  amount of activation in the electroencephalography (EEG) evoked by single-pulse transcranial magnetic stimulation (TMS)

  Change from Baseline to after 7 nights of chronic Sleep Deprivation

• Change in Reaction Times after Chronic Sleep Deprivation as measured by the Psychomotor Vigilance Task

  Reaction times in the Psychomotor vigilance task

  Change from Baseline to after 7 nights of chronic Sleep Deprivation

• 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

  Risk Task (adapted from Levy et al.) Delay Discounting Task (Kirby et al.)

  Change from Baseline to after 7 nights of chronic Sleep Deprivation

Secondary Outcomes (7)

• Slow Wave Activity during Sleep as measured by the power in the EEG in the frequency range of 1-4.5 Hz

  Baseline, 1st Recovery Night of total Sleep Deprivation, 5th, 6th, 7th night of partial Sleep Deprivation, 1st Recovery Night from partial Sleep Deprivation

• Dim Light Melatonin Onset as measured by the melatonin concentration in hourly collected saliva samples

  Baseline, 1st evening after partial Sleep Deprivation, 7th to 14th evening after partial Sleep Deprivation

• Skin Temperature profiles as measured by skin temperature sensors (Celsius)

  from 1 week prior to partial Sleep Deprivation to 8-14 days after

• Mood ratings as measured by a visual analog scale

  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

• subjective sleepines as measured by the stanford sleepiness scale

  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

Study Arms (2)

SDSR

EXPERIMENTAL

first total then partial Sleep deprivation

Behavioral: Sleep Deprivation

SRSD

EXPERIMENTAL

first partial then total Sleep deprivation

Behavioral: Sleep Deprivation

Interventions

Sleep Deprivation BEHAVIORAL

SDSR; SRSD

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male (in female subjects, menstrual cycle influences sleep)
• Age between 18-35 years
• Right-handedness
• Good general health
• Signed Informed Consent after being informed

You may not qualify if:

• 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

Sponsors & Collaborators

• Christian Baumann: lead

Study Sites (1)

University Hospital Zurich, Division of Neurology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor and leading physician

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: December 2, 2014
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: January 1, 2017
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

CH (1)