Sleep DeprivationNCT03227406
The Evolution of Memories Across Wake and Sleep
A study testing Sleep deprivation and Nap in people with Sleep Deprivation and Sleep, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
To further understanding of the relationship between sleep and memory the investigators will address and attempt to answer three questions, (1) how memories evolve across wake and sleep, (2) how different aspects of this memory evolution are reflected both behaviorally and in the EEG signal, and (3) what stages and… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Sleep
- What is being tested?
- Sleep deprivation and Nap
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 31 Jan 2023
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- willing and able to follow the protocol
- willing to refrain from alcohol and recreational drugs for the duration of the protocol
- in some cases, English as a first language, normal hearing, and/or normal or corrected to normal vision is required
Who cannot join
- self-reported sleep disturbances
- a history of mental illness
- the use of any drugs that could affect either sleep or cognitive functioning (e.g., sleeping pills or antidepressants)
Trial locations and contacts
1 site in 1 country.
About this study
To further understanding of the relationship between sleep and memory the investigators will address and attempt to answer three questions, (1) how memories evolve across wake and sleep, (2) how different aspects of this memory evolution are reflected both behaviorally and in the EEG signal, and (3) what stages and features of sleep affect memory evolution. Together, these studies will provide a greater breadth and depth of knowledge concerning sleep's role in memory consolidation. Such knowledge would be of practical importance for educational practices, whether in schools, on the job, or in the military, and would also provide valuable information to the fields of sleep medicine and psychiatry, where interactions between sleep disorders and cognitive functioning are of great importance.
Read the detailed description
Goal 1: How do memories evolve across wake and sleep? The investigators are interested in how specific memories are selected for change across periods of wake and sleep, and in characterizing the manner in which those memories change. There has been research into broad areas of memory, such as procedural and declarative memory, but other forms of memory, such as semantic memory, remain unexplored, as well as different subtypes of memory within these broad areas. Additionally, it is presently unknown how memories are selected for subsequent processing during sleep and wake. The investigators aim to characterize which memories change, how they are selected, and how they change differently over periods that include sleep versus periods during which participants remain awake.
Goal 2: How are these changes reflected behaviorally and in the EEG signal? The investigators will employ and develop specific behavioral and electrophysiological tasks and measures that allow one to probe the state of a particular type of memory and determine how it changes over periods of wake and sleep. EEG signals may be informative about the status of a memory during behavioral performance as well as during both waking and sleeping offline states.
Goal 3: What stages and features of sleep affect memory evolution? In the cases in which sleep in particular is found or suspected to influence memories in a unique way, the investigators will assess which stages and features of sleep are involved in that evolution. Generally, this will be accomplished by correlating measures such as time spent in a sleep stage, prominence of particular brain oscillations, or density of spindles with changes in behavior or in other EEG metrics
- Conditions
- Sleep Deprivation, Sleep
- Being tested
- Sleep deprivation, Nap
- Keywords
- sleep, memory, REM sleep, slow wave sleep, cognition, sleep spindles
- 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
Subjects are kept awake all night.
NapBehavioural
Participants are given a 90-minute nap opportunity in the early afternoon.
| Study group | Role | What they receive |
|---|---|---|
| Daytime Wake | No intervention | Subjects are trained and retested during a single period of daytime wake |
| Overnight sleep | No intervention | Subjects are trained on one day and tested the next day, after a night of normal sleep |
| Sleep deprivation | Experimental | Subjects are trained on one day and tested the next day, after a night of sleep deprivation Receives: Behavioral: Sleep deprivation |
| Daytime Nap | Experimental | Subjects are trained and then retested after a daytime nap Receives: Behavioral: Nap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor sequence task improvement
The increase in the number of correct sequences typed, from the last three training trials to the first three delayed-test trials, is calculated as a percent improvement.
Measured: 4-24 hrs
Psychomotor vigilance task lapse rate
The absolute number of trials in a 5-min test period on which the participant fails to responds with 500ms is calculated as the lapse rate.
Measured: 4-24 hrs
Serial reaction time test improvement
At two time points, separated by a period of wake or sleep, the average reaction time to stimuli in repeated sequence blocks is subtracted from the average reaction time in random blocks. The percent increase in this difference, from the final blocks in the first test to the first blocks in the second test, is calculated as a percent improvement.
Measured: 4-24 hrs
Visual discrimination task improvement
At two time points, separated by a period of wake or sleep, the interpolated stimulus-mask ISI corresponding to 80% accuracy on the texture discrimination task is determined, and task improvement is calculated as the difference between these thresholds, in ms.
Measured: 4-24 hrs
Secondary outcomes (4)
Sleep architecture (absolute times)
Sleep is recorded with standard polysomnography and the amount of time spent in each wake and sleep stage calculated.
Measured: 4-24 hrs
Sleep architecture (percent times)
The percent of total sleep time spent in each sleep stage is calculated.
Measured: 4-24 hrs
Spindle
The density of sleep spindles per minute of N2 sleep is calculated.
Measured: 4-24 hrs
Sleep microstructure
The EEG spectral power is calculated for N2 and N3 sleep.
Measured: 4-24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Mar 2016
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
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.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Robert Stickgold, Beth Israel Deaconess Medical Center
- Investigators
- Robert Stickgold, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227406
- Sponsor's protocol ID
- 2016P000222
- Other IDs
- R01MH048832
- Status last verified
- Feb 2023
- First submitted
- 19 Jul 2017
- Last updated
- 3 Feb 2023
- 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 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evolution of Memories Across Wake and Sleep
- ClinicalTrials.gov ID
- NCT03227406
- Acronym / sponsor ID
- 2016P000222
- Conditions
- Sleep Deprivation, Sleep
- Keywords
- sleep, memory, REM sleep, slow wave sleep, cognition, sleep spindles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 24 Jul 2017 (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.
To further understanding of the relationship between sleep and memory the investigators will address and attempt to answer three questions, (1) how memories evolve across wake and sleep, (2) how different aspects of this memory evolution are reflected both behaviorally and in the EEG signal, and (3) what stages and features of sleep affect memory evolution. Together, these studies will provide a greater breadth and depth of knowledge concerning sleep's role in memory consolidation. Such knowledge would be of practical importance for educational practices, whether in schools, on the job, or in the military, and would also provide valuable information to the fields of sleep medicine and psychiatry, where interactions between sleep disorders and cognitive functioning are of great importance.
Detailed description
Goal 1: How do memories evolve across wake and sleep? The investigators are interested in how specific memories are selected for change across periods of wake and sleep, and in characterizing the manner in which those memories change. There has been research into broad areas of memory, such as procedural and declarative memory, but other forms of memory, such as semantic memory, remain unexplored, as well as different subtypes of memory within these broad areas. Additionally, it is presently unknown how memories are selected for subsequent processing during sleep and wake. The investigators aim to characterize which memories change, how they are selected, and how they change differently over periods that include sleep versus periods during which participants remain awake.
Goal 2: How are these changes reflected behaviorally and in the EEG signal? The investigators will employ and develop specific behavioral and electrophysiological tasks and measures that allow one to probe the state of a particular type of memory and determine how it changes over periods of wake and sleep. EEG signals may be informative about the status of a memory during behavioral performance as well as during both waking and sleeping offline states.
Goal 3: What stages and features of sleep affect memory evolution? In the cases in which sleep in particular is found or suspected to influence memories in a unique way, the investigators will assess which stages and features of sleep are involved in that evolution. Generally, this will be accomplished by correlating measures such as time spent in a sleep stage, prominence of particular brain oscillations, or density of spindles with changes in behavior or in other EEG metrics
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Daytime Wake | No intervention | –Subjects are trained and retested during a single period of daytime wake |
| Overnight sleep | No intervention | –Subjects are trained on one day and tested the next day, after a night of normal sleep |
| Sleep deprivation | Experimental | Behavioral: Sleep deprivationSubjects are trained on one day and tested the next day, after a night of sleep deprivation |
| Daytime Nap | Experimental | Behavioral: NapSubjects are trained and then retested after a daytime nap |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- willing and able to follow the protocol
- willing to refrain from alcohol and recreational drugs for the duration of the protocol
- in some cases, English as a first language, normal hearing, and/or normal or corrected to normal vision is required
Key exclusion criteria (3 listed)
- self-reported sleep disturbances
- a history of mental illness
- the use of any drugs that could affect either sleep or cognitive functioning (e.g., sleeping pills or antidepressants)
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 deprivationSubjects are kept awake all night. | Behavioural | Sleep deprivation |
| NapParticipants are given a 90-minute nap opportunity in the early afternoon. | Behavioural | Daytime Nap |
Primary outcome
Motor sequence task improvement
Time frame: 4-24 hrs
The increase in the number of correct sequences typed, from the last three training trials to the first three delayed-test trials, is calculated as a percent improvement.
Psychomotor vigilance task lapse rate
Time frame: 4-24 hrs
The absolute number of trials in a 5-min test period on which the participant fails to responds with 500ms is calculated as the lapse rate.
Serial reaction time test improvement
Time frame: 4-24 hrs
At two time points, separated by a period of wake or sleep, the average reaction time to stimuli in repeated sequence blocks is subtracted from the average reaction time in random blocks. The percent increase in this difference, from the final blocks in the first test to the first blocks in the second test, is calculated as a percent improvement.
Visual discrimination task improvement
Time frame: 4-24 hrs
At two time points, separated by a period of wake or sleep, the interpolated stimulus-mask ISI corresponding to 80% accuracy on the texture discrimination task is determined, and task improvement is calculated as the difference between these thresholds, in ms.
4 secondary outcomes
Sleep architecture (absolute times)
Time frame: 4-24 hrs
Sleep architecture (percent times)
Time frame: 4-24 hrs
Spindle
Time frame: 4-24 hrs
Sleep microstructure
Time frame: 4-24 hrs
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 3 Feb 2023.
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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.
Robert Stickgold, PhD principal investigator
Beth Israel Deaconess Medical Center
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 and Nap in people with Sleep Deprivation and Sleep, run by Beth Israel Deaconess Medical Center 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 3 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 3 Feb 2023. 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?
Motor sequence task improvement (time frame: 4-24 hrs). The study lists 4 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 3 Feb 2023.