Sleep DeprivationNCT01651429
Predicting Cognitive Resilience Against Sleep Loss
A study testing Sleep deprivation in people with Sleep Deprivation, run by Mclean Hospital at 1 site in United States.
Trial summary
Resilience is the ability to cope effectively and adapt to a wide range of stressful environmental challenges. Sleep loss has been shown to reduce activity in the brain regions responsible for resilience. The ability to resist the effects of sleep loss appears to be a stable, trait-like quality. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jun 2014
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-45 years
- Right handedness as assessed by the Edinburgh Handedness Inventory
- For women: regular menstrual cycles (duration between 25 and 35 days with no more than 3 day variation between cycle)
Who cannot join
- History of head injury with loss of consciousness or post-traumatic amnesia, or major neurological illness
- Medical or neurologic condition that would confound interpretation of results, including alcohol or drug abuse/dependence in the past 6 months, neurological disorders including any history of seizures
- History of cardiac problems
- History of major depressive disorder or anxiety disorder
- Lifetime history of psychotic disorder, including bipolar disorder, schizophrenia, or obsessive compulsive disorder
- Other DSM-IV diagnosis that could affect interpretation of results
Show all 13Show fewer
- Mixed or left handedness
- Abnormal visual acuity that cannot be corrected by contact lenses
- Daily caffeine use exceeding 400 mg per day
- History of smoking or tobacco use in the past year
- Metal within the body, pregnancy, or other contraindication for MRI procedures
- Use of drugs or medications that could affect functional neuroimaging results (e.g., fluoxetine, beta-blockers)
- Psychotropic medication use within the past 6 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Neuroimaging to Predict Cognitive Resilience Against Sleep Loss
Resilience is the ability to cope effectively and adapt to a wide range of stressful environmental challenges. Sleep loss has been shown to reduce activity in the brain regions responsible for resilience. The ability to resist the effects of sleep loss appears to be a stable, trait-like quality. This study will attempt to predict individuals' trait-resistance to sleep loss based on their neurobiology.
Read the detailed description
Resilience, the ability to cope effectively and adapt to a wide range of stressful environmental challenges, appears to be mediated extensively by the medial prefrontal cortex (MPFC). Sleep deprivation has been shown to reduce metabolic activity throughout the brain, particularly the MPFC. The ability to resist the effects of sleep loss appears to be a stable, trait-like phenomenon that is consistent across situations, suggesting that it may reflect an enduring quality of the underlying neurobiological system. The present study aims to identify the neural basis of resilience and effectively discriminate resistant from vulnerable individuals during an overnight sleep deprivation session. Specifically, the primary aims of this research are 1) to further our understanding of the role of the MPFC in resilience and 2) to develop a statistical prediction algorithm based on multimodal neuroimaging that will reliably discriminate between individuals who are resilient versus vulnerable to the cognitive impairing effects of sleep loss.
- Conditions
- Sleep Deprivation
- Being tested
- Sleep deprivation
- Keywords
- Sleep Deprivation
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep deprivationBehavioural
Participants will undergo 29 hours of sleep deprivation. They will wake up at 7:00 am on the day of the study and remain awake in the laboratory until 12:00 pm the next day.
| Study group | Role | What they receive |
|---|---|---|
| Sleep deprivation | Experimental | Participants will undergo 29 hours of sleep deprivation, 17 of which will be spent in the laboratory. Receives: Behavioral: Sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the medial prefrontal cortex (MPFC) as measured by fMRI, DTI, and MRS
It is hypothesized that, relative to vulnerable individuals, those who are highly resistant to the adverse effects of sleep loss on cognition will show: 1) increased gray matter volume in the MPFC, 2) greater white matter integrity as indicated by the Diffusion Tensor Imaging measure of fractional anisotropy (FA) values in the MPFC, 3) greater functional activation in MPFC during cognitively demanding tasks, 4) greater functional connectivity between MPFC and alerting regions of the midbrain and thalamus; and 5) different ratios of GABA and glutamate within the MPFC.
Measured: Session 2 of study (1 week after enrollment)
Secondary outcomes (1)
Psychomotor Vigilance Task (PVT)
The PVT will be administered 17 throughout the overnight sleep deprivation session. PVT performance measures participants' alertness and objective resilience to sleep deprivation. PVT performance will be used as a measure to retrospectively assign participants into sleep loss-resistant and sleep loss-vulnerable groups.
Measured: At sleep deprivation session (2 weeks after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startApr 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Killgore, Mclean Hospital
- Investigators
- William D Killgore, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651429
- Sponsor's protocol ID
- D12AP00241
- Status last verified
- Jun 2014
- First submitted
- 23 Jul 2012
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Neuroimaging to Predict Cognitive Resilience Against Sleep Loss
- ClinicalTrials.gov ID
- NCT01651429
- Acronym / sponsor ID
- D12AP00241
- Conditions
- Sleep Deprivation
- Keywords
- Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Jul 2012 (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.
Resilience is the ability to cope effectively and adapt to a wide range of stressful environmental challenges. Sleep loss has been shown to reduce activity in the brain regions responsible for resilience. The ability to resist the effects of sleep loss appears to be a stable, trait-like quality. This study will attempt to predict individuals' trait-resistance to sleep loss based on their neurobiology.
Detailed description
Resilience, the ability to cope effectively and adapt to a wide range of stressful environmental challenges, appears to be mediated extensively by the medial prefrontal cortex (MPFC). Sleep deprivation has been shown to reduce metabolic activity throughout the brain, particularly the MPFC. The ability to resist the effects of sleep loss appears to be a stable, trait-like phenomenon that is consistent across situations, suggesting that it may reflect an enduring quality of the underlying neurobiological system. The present study aims to identify the neural basis of resilience and effectively discriminate resistant from vulnerable individuals during an overnight sleep deprivation session. Specifically, the primary aims of this research are 1) to further our understanding of the role of the MPFC in resilience and 2) to develop a statistical prediction algorithm based on multimodal neuroimaging that will reliably discriminate between individuals who are resilient versus vulnerable to the cognitive impairing effects of sleep loss.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep deprivation | Experimental | Behavioral: Sleep deprivationParticipants will undergo 29 hours of sleep deprivation, 17 of which will be spent in the laboratory. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 20-45 years
- Right handedness as assessed by the Edinburgh Handedness Inventory
- For women: regular menstrual cycles (duration between 25 and 35 days with no more than 3 day variation between cycle)
Key exclusion criteria (13 listed)
- History of head injury with loss of consciousness or post-traumatic amnesia, or major neurological illness
- Medical or neurologic condition that would confound interpretation of results, including alcohol or drug abuse/dependence in the past 6 months, neurological disorders including any history of seizures
- History of cardiac problems
- History of major depressive disorder or anxiety disorder
- Lifetime history of psychotic disorder, including bipolar disorder, schizophrenia, or obsessive compulsive disorder
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 deprivationParticipants will undergo 29 hours of sleep deprivation. They will wake up at 7:00 am on the day of the study and remain awake in the laboratory until 12:00 pm the next day. | Behavioural | Sleep deprivation |
Primary outcome
Differences in the medial prefrontal cortex (MPFC) as measured by fMRI, DTI, and MRS
Time frame: Session 2 of study (1 week after enrollment)
It is hypothesized that, relative to vulnerable individuals, those who are highly resistant to the adverse effects of sleep loss on cognition will show: 1) increased gray matter volume in the MPFC, 2) greater white matter integrity as indicated by the Diffusion Tensor Imaging measure of fractional anisotropy (FA) values in the MPFC, 3) greater functional activation in MPFC during cognitively demanding tasks, 4) greater functional connectivity between MPFC and alerting regions of the midbrain and thalamus; and 5) different ratios of GABA and glutamate within the MPFC.
1 secondary outcome
Psychomotor Vigilance Task (PVT)
Time frame: At sleep deprivation session (2 weeks after enrollment)
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 16 Jun 2014.
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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.
William D Killgore, PhD principal investigator
Mclean Hospital
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 Sleep Deprivation, run by Mclean Hospital at 1 site in United States.
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 3 inclusion and 13 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 16 Jun 2014. 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 United States. 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?
Differences in the medial prefrontal cortex (MPFC) as measured by fMRI, DTI, and MRS (time frame: Session 2 of study (1 week after enrollment)). 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 16 Jun 2014.