Sleep RestrictionDM-SRNCT03692962
Decision-making After Sleep Restriction
A study testing Sleep restriction and Acoustic stimulation in people with Sleep Restriction, run by Christian Baumann at 1 site in Switzerland.
Trial summary
The aim of this project is to investigate whether enhancing sleep intensity locally in the prefrontal cortex (PFC) can counteract a deterioration of cognitive control and therefore the previously described increase in risk seeking during chronic sleep restriction. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Restriction
- What is being tested?
- Sleep restriction and Acoustic stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2018to 2 Nov 2020
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-21 years or 26-30 years,
- Right-handedness,
- Good general health,
- Good understanding of German language (as all information is provided in German)
- 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,
- Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases),
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- Sleep disorders (e.g. Insomnia, sleep apnoea, restless leg syndrome, narcolepsy, etc.),
- Sleep complaints in general or excessive daytime sleepiness (Pittsburgh Sleep Quality Index > 5; Epworth Sleepiness Scale ≥ 11),
- Irregular sleep-wake rhythm (e.g. shift working),
- Long (> 10 hours per night) or short sleepers (< 7 hours per night),
- Sleep efficiency < 80% in screening night,
- Travelling with time lag less than 1 month ago (or planning to do so within 1 month prior to or during the study),
- > 5 drinks or food items containing caffeine per day,
- > 5 cigarettes per day,
- Body Mass Index < 19 or > 30 kg/m2,
- Skin allergy or very sensitive skin
- 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).
- Red-Green Colour-Blindness (as the Risk Task requires the distinction between red and green),
- History of claustrophobia,
- Known hearing disorder (as acoustic stimuli will be applied during sleep),
- Magnetic Resonance (MR) contraindication (such as pacemaker, implanted pumps, shrapnel, etc.; full MR Screening form will be filled out).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Linking the Change in Decision-making After Sleep Restriction to the Restorative Function of Sleep
The aim of this project is to investigate whether enhancing sleep intensity locally in the prefrontal cortex (PFC) can counteract a deterioration of cognitive control and therefore the previously described increase in risk seeking during chronic sleep restriction. To this end, a controlled, counter-balanced study, consisting of two weeks of sleep restriction will be performed. During one of the sleep restriction weeks, sleep intensity in the PFC will be non-invasively enhanced by acoustic stimulation of slow waves during sleep.
- Conditions
- Sleep Restriction
- Being tested
- Sleep restriction, Acoustic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep restrictionBehavioural
Time in bed will be restricted to 5 hours per night for 7 nights.
Acoustic stimulationOther
Brief tones will be presented time-locked to ongoing slow waves during deep sleep.
| Study group | Role | What they receive |
|---|---|---|
| Sleep restriction without acoustic stimulation | Sham comparator | Not described Receives: Behavioral: Sleep restriction |
| Sleep restriction with acoustic stimulation | Experimental | Not described Receives: Behavioral: Sleep restriction; Other: Acoustic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk-premium
risk-preference (i.e. risk premium assessed with the risk Task as described in Maric et al. 2017 Ann Neurol) after chronic sleep restriction with and without acoustic Stimulation will be quantified by the risk-premium derived from the choices made in the risk-task as described in Maric et al. 2017 Ann Neurol.
Measured: comparison of change from baseline after 7 nights of sleep restriction with acoustic stimulation to change from baseline after 7 nights of sleep restriction without acoustic stimulation
Secondary outcomes (11)
high-density electroencephalography (hdEEG) marker of sleep pressure
Slow wave activity (SWA) assessed by hd-EEG with 128 electrodes
Measured: assessed during first and last sleep restriction nights in comparison to baseline values
brain metabolites
Glutamate and gamma-aminobutyric acid (GABA) concentration in the right prefrontal Cortex assessed by magnetic resonance (MR) spectroscopy
Measured: before to after 7 nights of sleep restriction with and without acoustic stimulation
vigilance measures
Performance impairments in the psychomotor-vigilance task
Measured: before to after 7 nights of sleep restriction with and without acoustic stimulation
deception willingness
deception willingness measured by the willingness to deception of outcome in a card game with binary outcome (win and loss)
Measured: before to after 7 nights of sleep restriction with and without acoustic stimulation
Motor inhibitory control performance
inhibitory control performance measured by the stop-signal-task.
Measured: before to after 7 nights of sleep restriction with and without acoustic stimulation
confidence
overconfidence measured by an incentivised procedure that elicits the certainity equivalent of a bet based on Performance in a quiz (cf. Murad et al. 2016 J Risk Uncertain)
Measured: before to after 7 nights of sleep restriction with and without acoustic stimulation
overconfidence
overconfidence measured by an incentivised procedure that elicits the certainity equivalent of a bet based on Performance in a quiz (cf. Murad et al. 2016 J Risk Uncertain)
Measured: before to after 7 nights of sleep restriction with and without acoustic stimulation
impulsivity
impulsivity as measured by an intertemporal choice Task.
Measured: before to after 7 nights of sleep restriction with and without acoustic stimulation
Ocular inhibitory control performance
Ocular inhibitory control Performance measured by the Anti-Saccade Task.
Measured: before to after 7 nights of sleep restriction with and without acoustic stimulation
Effort in inhibitory control performance
Pupil response (i.e. dilation) during a simple Go/No-Go Task.
Measured: before to after 7 nights of sleep restriction with and without acoustic stimulation
Excessive daytime sleepiness
Excessive daytime sleepiness assessed by the Epworth sleepiness scale and the Stanford Sleepiness Scale.
Measured: before to after 7 nights of sleep restriction with and without acoustic stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Sep 2018
- Primary completion12 Oct 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep RestrictionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Baumann
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology in Zurich (ETH Zurich)
- Responsible party
- Sponsor-investigator, Christian Baumann, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692962
- Sponsor's protocol ID
- DM-SR
- Acronym
- DM-SR
- Status last verified
- Feb 2021
- First submitted
- 4 Jun 2018
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking the Change in Decision-making After Sleep Restriction to the Restorative Function of Sleep
- ClinicalTrials.gov ID
- NCT03692962
- Acronym / sponsor ID
- DM-SR / DM-SR
- Conditions
- Sleep Restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Christian BaumannUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology in Zurich (ETH Zurich)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 2 Oct 2018 (actual)
- 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 aim of this project is to investigate whether enhancing sleep intensity locally in the prefrontal cortex (PFC) can counteract a deterioration of cognitive control and therefore the previously described increase in risk seeking during chronic sleep restriction. To this end, a controlled, counter-balanced study, consisting of two weeks of sleep restriction will be performed. During one of the sleep restriction weeks, sleep intensity in the PFC will be non-invasively enhanced by acoustic stimulation of slow waves during sleep.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep restriction without acoustic stimulation | Sham comparator | Behavioral: Sleep restriction |
| Sleep restriction with acoustic stimulation | Experimental | Behavioral: Sleep restriction, Other: Acoustic stimulation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18-21 years or 26-30 years,
- Right-handedness,
- Good general health,
- Good understanding of German language (as all information is provided in German)
- Signed Informed Consent after being informed.
Key exclusion criteria (21 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 restrictionTime in bed will be restricted to 5 hours per night for 7 nights. | Behavioural | Sleep restriction with acoustic stimulation, Sleep restriction without acoustic stimulation |
| Acoustic stimulationBrief tones will be presented time-locked to ongoing slow waves during deep sleep. | Other | Sleep restriction with acoustic stimulation |
Primary outcome
risk-premium
Time frame: comparison of change from baseline after 7 nights of sleep restriction with acoustic stimulation to change from baseline after 7 nights of sleep restriction without acoustic stimulation
risk-preference (i.e. risk premium assessed with the risk Task as described in Maric et al. 2017 Ann Neurol) after chronic sleep restriction with and without acoustic Stimulation will be quantified by the risk-premium derived from the choices made in the risk-task as described in Maric et al. 2017 Ann Neurol.
11 secondary outcomes
high-density electroencephalography (hdEEG) marker of sleep pressure
Time frame: assessed during first and last sleep restriction nights in comparison to baseline values
brain metabolites
Time frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
vigilance measures
Time frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
deception willingness
Time frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
Motor inhibitory control performance
Time frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
confidence
Time frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
overconfidence
Time frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
impulsivity
Time frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
Ocular inhibitory control performance
Time frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
Effort in inhibitory control performance
Time frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
Excessive daytime sleepiness
Time frame: before to after 7 nights of sleep restriction with and without acoustic stimulation
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 11 Feb 2021.
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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 restriction and Acoustic stimulation in people with Sleep Restriction, 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 21 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 11 Feb 2021. 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. Some participants in this study may receive a placebo. 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?
risk-premium (time frame: comparison of change from baseline after 7 nights of sleep restriction with acoustic stimulation to change from baseline after 7 nights of sleep restriction without acoustic stimulation). 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 11 Feb 2021.