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

November 18, 2020 updated by: Christian Baumann

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SDSR
first total then partial Sleep deprivation
Experimental: SRSD
first partial then total Sleep deprivation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cortical excitability after Chronic Sleep Deprivation as measured by TMS evoked responses in the EEG
Time Frame: Change from Baseline to after 7 nights of chronic Sleep Deprivation
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
Time Frame: Change from Baseline to after 7 nights of chronic Sleep Deprivation
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
Time Frame: Change from Baseline to after 7 nights of chronic Sleep Deprivation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Slow Wave Activity during Sleep as measured by the power in the EEG in the frequency range of 1-4.5 Hz
Time Frame: Baseline, 1st Recovery Night of total Sleep Deprivation, 5th, 6th, 7th night of partial Sleep Deprivation, 1st Recovery Night from partial Sleep Deprivation
Slow wave activity recorded during the night in the electroencephalography
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
Time Frame: Baseline, 1st evening after partial Sleep Deprivation, 7th to 14th evening after partial Sleep Deprivation
Melatonin concentration curve in saliva samples collected hourly prior to going to bed
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)
Time Frame: from 1 week prior to partial Sleep Deprivation to 8-14 days after
Skin temperature (Celsius) is measured every 5 minutes
from 1 week prior to partial Sleep Deprivation to 8-14 days after
Mood ratings as measured by a visual analog scale
Time Frame: 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
Mood Ratings from 1-10
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
Time Frame: 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
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
Working Memory performance as measured by errors of comission and omission the n-back Task
Time Frame: 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
2-back and 3-back task: measures of comission and omission
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
metabolic profile as measured by metabolites in saliva
Time Frame: Baseline Day 1, 1st Day of total Sleep Deprivation, 8th Day of partial Sleep Deprivation
Screening for metabolites that are changes due to sleep loss
Baseline Day 1, 1st Day of total Sleep Deprivation, 8th Day of partial Sleep Deprivation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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