Acute and Partial Sleep DeprivationNCT02305225
Cortical Excitability and Decision Making After Total Sleep Deprivation and Sleep Restriction
A study testing Sleep Deprivation in people with Acute and Partial Sleep Deprivation, run by Christian Baumann at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute and Partial Sleep Deprivation
- What is being tested?
- Sleep Deprivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to 1 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male (in female subjects, menstrual cycle influences sleep)
- Age between 18-35 years
- Right-handedness
- Good general health
- Signed Informed Consent after being informed
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Neurology
Zurich, Canton of Zurich, 8091
About this study
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
- Being tested
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep DeprivationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| SDSR | Experimental | first total then partial Sleep deprivation Receives: Behavioral: Sleep Deprivation |
| SRSD | Experimental | first partial then total Sleep deprivation Receives: Behavioral: Sleep Deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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.)
Measured: 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
Slow wave activity recorded during the night in the electroencephalography
Measured: 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
Melatonin concentration curve in saliva samples collected hourly prior to going to bed
Measured: 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)
Skin temperature (Celsius) is measured every 5 minutes
Measured: from 1 week prior to partial Sleep Deprivation to 8-14 days after
Mood ratings as measured by a visual analog scale
Mood Ratings from 1-10
Measured: 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
Stanford sleepiness scale
Measured: 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
2-back and 3-back task: measures of comission and omission
Measured: 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
Screening for metabolites that are changes due to sleep loss
Measured: Baseline Day 1, 1st Day of total Sleep Deprivation, 8th Day of partial Sleep Deprivation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute and Partial Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Baumann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Baumann, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305225
- Sponsor's protocol ID
- 2012-0496
- Status last verified
- Nov 2020
- First submitted
- 7 Nov 2014
- Last updated
- 20 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Excitability and Decision Making After Total Sleep Deprivation and Sleep Restriction
- ClinicalTrials.gov ID
- NCT02305225
- Acronym / sponsor ID
- 2012-0496
- Conditions
- Acute and Partial Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Christian BaumannUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDSR | Experimental | Behavioral: Sleep Deprivationfirst total then partial Sleep deprivation |
| SRSD | Experimental | Behavioral: Sleep Deprivationfirst partial then total Sleep deprivation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male (in female subjects, menstrual cycle influences sleep)
- Age between 18-35 years
- Right-handedness
- Good general health
- Signed Informed Consent after being informed
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Deprivation | Behavioural | SDSR, SRSD |
Primary outcome
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 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 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.)
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Deprivation in people with Acute and Partial Sleep Deprivation, run by Christian Baumann at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.