The Evolution of Memories Across Wake and Sleep

July 24, 2021 updated by: Robert Stickgold, Beth Israel Deaconess Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1650

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Robert Stickgold

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Behavioral: Sleep deprivation
Subjects are kept awake all night.
Experimental: Daytime Nap
Subjects are trained and then retested after a daytime nap
Behavioral: Nap
Participants are given a 90-minute nap opportunity in the early afternoon.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beth Israel Deaconess Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Stickgold, PhD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016P000222
  • 5R01MH048832-23 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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