- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03227406
The Evolution of Memories Across Wake and Sleep
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Robert Stickgold
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Daytime Wake
Subjects are trained and retested during a single period of daytime wake
|
|
|
No Intervention: Overnight sleep
Subjects are trained on one day and tested the next day, after a night of normal sleep
|
|
|
Experimental: Sleep deprivation
Subjects are trained on one day and tested the next day, after a night of sleep deprivation
|
Subjects are kept awake all night.
|
|
Experimental: Daytime Nap
Subjects are trained and then retested after a daytime nap
|
Participants are given a 90-minute nap opportunity in the early afternoon.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4-24 hrs
|
|
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.
|
4-24 hrs
|
|
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.
|
4-24 hrs
|
|
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.
|
4-24 hrs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep architecture (absolute times)
Time Frame: 4-24 hrs
|
Sleep is recorded with standard polysomnography and the amount of time spent in each wake and sleep stage calculated.
|
4-24 hrs
|
|
Sleep architecture (percent times)
Time Frame: 4-24 hrs
|
The percent of total sleep time spent in each sleep stage is calculated.
|
4-24 hrs
|
|
Spindle
Time Frame: 4-24 hrs
|
The density of sleep spindles per minute of N2 sleep is calculated.
|
4-24 hrs
|
|
Sleep microstructure
Time Frame: 4-24 hrs
|
The EEG spectral power is calculated for N2 and N3 sleep.
|
4-24 hrs
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert Stickgold, PhD, Beth Israel Deaconess Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016P000222
- 5R01MH048832-23 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep
-
University of Wisconsin, MadisonPhilips HealthcareCompletedSleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
-
Brain Electrophysiology Laboratory CompanyRecruiting
-
University GhentEuropean CommissionCompleted
-
Mahidol UniversityRamathibodi HospitalNot yet recruitingSleep Inertia | Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization | Night Shift WorkThailand
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
-
Universidade Federal de PernambucoEnrolling by invitationSleep | Obstructive Sleep Apnea (OSA)Brazil
-
Atlas UniversityCompletedSleep | Surgery | Sleep QualityTurkey (Türkiye)
-
Mersin UniversityCompletedSleep Quality | Sleep PerceptionTurkey (Türkiye)
-
Brigham and Women's HospitalNot yet recruitingObstructive Sleep Apnea | Sleep-disordered BreathingUnited States
-
Institute of Nutrition, Slovenia (Nutris)Valens Int. d.o.o., Slovenija; Faculty of Pharmacy, University of Ljubljana... and other collaboratorsNot yet recruitingSleep Quality | Sleep Onset LatencySlovenia
Clinical Trials on Sleep deprivation
-
Federal University of São PauloCompleted
-
Centre Hospitalier Universitaire de Saint EtienneJean Monnet UniversityRecruiting
-
Esther WerthCompletedIdiopathic Hypersomnia | Narcolepsy 1Switzerland
-
University of OttawaCompletedSleep Disturbance | Exercise | Aging | Thermoregulation | Heat ExchangeCanada
-
University of ZurichFonds für Verkehrssicherheit FVSCompletedSleep Deprivation | Sleepiness | Insufficient Sleep SyndromeSwitzerland
-
Boston University Charles River CampusBrain & Behavior Research Foundation; One Mind; 1907 FoundationRecruiting
-
Yoav GimonCompleted
-
Charite University, Berlin, GermanyCompleted