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

NCT ID: NCT02305225

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

SDSR

first total then partial Sleep deprivation

Group Type: EXPERIMENTAL

Sleep Deprivation

Intervention Type: BEHAVIORAL

SRSD

first partial then total Sleep deprivation

Group Type: EXPERIMENTAL

Sleep Deprivation

Intervention Type: BEHAVIORAL

Interventions

Sleep Deprivation

Intervention Type: BEHAVIORAL

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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Christian Baumann

OTHER

Sponsor Role: lead

Responsible Party

Christian Baumann

Associate professor and leading physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University Hospital Zurich, Division of Neurology

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

2012-0496

Identifier Type: -

Identifier Source: org_study_id