SleepNCT04702152
The Effects of Direct Context Reactivation During Sleep on Memory
A study testing Targeted memory reactivation (sounds) in people with Sleep and Consolidation, run by Northwestern University at 1 site in United States.
Trial summary
The context in which memories are encoded is a major factor influencing how memories are organized. Individual memories are bound to the context (e.g., the location, time and state of mind in which they are encoded) and this context is later reinstated to recall the details related to the memory. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Consolidation
- What is being tested?
- Targeted memory reactivation (sounds)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 30 Nov 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ---
Who cannot join
- Participants with a history of neurological disorders or of sleep disorders will be excluded.
- Participants who do not believe they would be able to fall asleep in the lab will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cognitive Neuroscience Lab - Northwestern University
Evanston, Illinois, 60208
About this study
Official title: The Role of Context in Sleep-related Memory Reactivation in Humans: the Effects of Direct Context Reactivation During Sleep on Memory
The context in which memories are encoded is a major factor influencing how memories are organized. Individual memories are bound to the context (e.g., the location, time and state of mind in which they are encoded) and this context is later reinstated to recall the details related to the memory. Although the role of context has been explored with regard to memory encoding and retrieval, its role during sleep-related memory consolidation has not been explored. Memories are thought to be reactivated during sleep, subsequently benefitting from the process. This study will use encephalography (EEG) in humans to consider several competing hypotheses regarding context's role in sleep reactivation, thereby enhancing the current understanding of how reactivation of memory over sleep relates to models of context and memory. Participants will learn to associate pictures of scenes to different sounds and to smaller images of items and animals, and then learn the spatial locations of these smaller images on a grid. Crucially, for half of these scenes, the sounds themselves will then also be linked directly to some of images during training. The associated sounds will then be unobtrusively presented during sleep, in a manner that has been shown to improve associated memories. The subsequent memory benefits will reveal whether (1) all images associated with the cued scene will benefit from cuing, demonstrating a context-reactivation effect; (2) only the images directly associated with presented sound will benefit from the cuing, demonstrating a item-reactivation effect; or (3) some composite of these two models. Regardless of which hypothesis is correct, the results will expand our current understanding regarding the role context plays in sleep consolidation.
Read the detailed description
Each participant will be run in a single afternoon, which includes a 90-minute nap opportunity. Before the nap, participants will go through training and test sessions - and after it they will partake of final memory tests. Neural activity will be continuously monitored and recorded throughout the task using electrophysiological equipment.
This is a within-subjects study. The main manipulation is the unobtrusive presentation of sounds during sleep, a technique called targeted memory reactivation (TMR). All participants will hear these sounds, but the specific sounds each one will hear will be different. The results will then be compared within participant, not between different groups or individuals. Appropriate statistical methods for such analyses include paired t-test and repeated measures analysis of variance. The choice of which sounds will be presented to each participant will be made based on their performance in the pre-sleep test. This will be done in an attempt to balance pre-sleep scores between presented and unpresented stimuli to remove statistical noise. Both the participant and the experimenter will be blind to which sounds will be presented, and the selection will be automatically made by the computer. This technique has been extensively used and has no known risks.
There are two main reasons that using a within-subject design reduces the required sample size. First, the lack of a between-subject independent variable intuitively requires less participants. Second, the level of statistical noise due to individual differences is reduced (i.e., because each participant is compared with their own scores). Previous TMR studies, which have found significant cuing effects, commonly used 20-25 participants. I plan to include at least 30 participants in this study, after omitting participants who could not complete the task and those who were not sufficiently cued during sleep. Having 30 participants will allow the use of more powerful statistical methods (in accordance with the common rule of thumb derived from the central limit theorem, which states that means based on sample sizes of more than 30 participants can be assumed to follow a normal distribution). I expect the context-related TMR effect (see summary) to be smaller in magnitude relative to the common effect size observed in spatial learning TMR studies (Hedge's g = 0.39 based on a recent meta-analysis). This is why I included a higher sample size. It is important to note that even if this benefit will be of a smaller magnitude, as I expect, it will still be indicative of the underlying neurocognitive process and therefore extremely valuable for our mechanistic understanding of the role of context in sleep. Aiming at a sample size of at least 30 participants and assuming an omission rate of 80%, I therefore plan to have 38 participants altogether.
Here is a brief summary of the procedure:
Stimuli: 16 images of spatial scenes (e.g., a beach) will each be arbitrarily associated with a sound and with four smaller images of objects or animals. Half of the scenes will be randomly designated to the context-reactivation (CR) condition and half to the item-reactivation (IR) condition (see below). The 64 images will each have a unique 2D position on a circular grid presented on the screen.
Training: Participants will first learn to associate each scene with the paired sound up to criterion. Next, they will learn to associate the scene with its four images up to criterion. The last part of training will include two type of learning blocks that will be interspersed. During the spatial-training blocks, in each trial participants will have to place a single image in its correct location. They will then receive feedback to improve. The scene associated with the image will be presented while they learn, but crucially the sound will never be presented for the CR condition scenes. For the IR scenes, the sound will be presented while learning two of the items, but never for the other two.
An alternative design might have divorced the cued items in the CR condition from the scenes altogether; the items could have been associated with novel sounds (i.e., that were not connected to the scene) and not presented along with their scene. However, using such a design would have introduced a confounding factor. The novel sound may have still been associated, to an unknown degree, not only to the item but also to the context to which it belongs. The degree to which this novel sound would be associated with the context would therefore remain uncontrolled and may vary between participants and scenes. Sounds used for item in the IR condition are always additionally associated with the scene. By always having the sounds be associated both with context and - in the IR condition - additionally to items, I substantially reduce any interpretation issues.
During the Sound-scenes blocks, which do not include a spatial component or the smaller images at all, the scenes will be presented with the sounds only for the CR condition scenes (i.e., to balance the number of sound presentations between conditions). These blocks will repeat in an interleaved manner until each participant will reach the pre-set learning criterion on the spatial-task.
Pre-sleep test: After training, participants will be tested on their spatial-memory for all items without exposure to sounds or scenes.
Sleep: During NREM (non-rapid eye movement) sleep, the sounds associated with half of the CR condition scenes and half of the IR condition scenes will be presented unobtrusively. The choice of which sounds to present will be made in a manner that will balance pre-sleep results and therefore enhance the contrast between sleep-related effects for cued and non-cued images.
Post-sleep test: At least 10 minutes after the end of the nap, participants will undergo a test identical to the pre-sleep one. Immediately after, they will be tested on the scene-item and scene-sound associations using both a free-recall and a recognition test. Participants will then be thanked, debriefed, paid and dismissed.
- Conditions
- Sleep, Consolidation
- Being tested
- Targeted memory reactivation (sounds)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted memory reactivation (sounds)Behavioural
I will unobtrusively and repeatedly present learning-related sounds during sleep using speakers. This method was shown to improve memory in various tasks. The sounds will be presented several seconds apart and the volume will be so adjusted as not to disturb the participant's sleep. The sounds will be presented during non-rapid eye movement sleep (sleep stage 2 and slow wave sleep). The sounds presented will be non-congruently related to the scenes in the previous learning task. This manipulation is within-subject - all participants will get it, but different specific sounds will be presented for each individual participant.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | This is a within-subject study with a single group of participants Receives: Behavioral: Targeted memory reactivation (sounds) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in error rates between pre- and post-sleep for the different conditions
The correct location of an image is compared with the position in which the participant has placed it. Measured in pixels on a computer screen.
Measured: Approximately 15 minutes before sleep onset and approximately 15 minutes after sleep offset within the same experimental session
Modulation of EEG spectral power following sound/odor presentation
Power modulations within the sigma (12-16 Hz), theta (4-8 Hz) and delta (0.5-4 Hz) ranges immediately following sound onset. Measured across different EEG channels.
Measured: During sleep within the experimental session, assessed up to 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start15 Sep 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eitan Schechtman-Drayman, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702152
- Sponsor's protocol ID
- STU00213443-A
- Status last verified
- Jan 2022
- First submitted
- 6 Jan 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Context in Sleep-related Memory Reactivation in Humans: the Effects of Direct Context Reactivation During Sleep on Memory
- ClinicalTrials.gov ID
- NCT04702152
- Acronym / sponsor ID
- STU00213443-A
- Conditions
- Sleep, Consolidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 8 Jan 2021 (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 context in which memories are encoded is a major factor influencing how memories are organized. Individual memories are bound to the context (e.g., the location, time and state of mind in which they are encoded) and this context is later reinstated to recall the details related to the memory. Although the role of context has been explored with regard to memory encoding and retrieval, its role during sleep-related memory consolidation has not been explored. Memories are thought to be reactivated during sleep, subsequently benefitting from the process. This study will use encephalography (EEG) in humans to consider several competing hypotheses regarding context's role in sleep reactivation, thereby enhancing the current understanding of how reactivation of memory over sleep relates to models of context and memory. Participants will learn to associate pictures of scenes to different sounds and to smaller images of items and animals, and then learn the spatial locations of these smaller images on a grid. Crucially, for half of these scenes, the sounds themselves will then also be linked directly to some of images during training. The associated sounds will then be unobtrusively presented during sleep, in a manner that has been shown to improve associated memories. The subsequent memory benefits will reveal whether (1) all images associated with the cued scene will benefit from cuing, demonstrating a context-reactivation effect; (2) only the images directly associated with presented sound will benefit from the cuing, demonstrating a item-reactivation effect; or (3) some composite of these two models. Regardless of which hypothesis is correct, the results will expand our current understanding regarding the role context plays in sleep consolidation.
Detailed description
Each participant will be run in a single afternoon, which includes a 90-minute nap opportunity. Before the nap, participants will go through training and test sessions - and after it they will partake of final memory tests. Neural activity will be continuously monitored and recorded throughout the task using electrophysiological equipment.
This is a within-subjects study. The main manipulation is the unobtrusive presentation of sounds during sleep, a technique called targeted memory reactivation (TMR). All participants will hear these sounds, but the specific sounds each one will hear will be different. The results will then be compared within participant, not between different groups or individuals. Appropriate statistical methods for such analyses include paired t-test and repeated measures analysis of variance. The choice of which sounds will be presented to each participant will be made based on their performance in the pre-sleep test. This will be done in an attempt to balance pre-sleep scores between presented and unpresented stimuli to remove statistical noise. Both the participant and the experimenter will be blind to which sounds will be presented, and the selection will be automatically made by the computer. This technique has been extensively used and has no known risks.
There are two main reasons that using a within-subject design reduces the required sample size. First, the lack of a between-subject independent variable intuitively requires less participants. Second, the level of statistical noise due to individual differences is reduced (i.e., because each participant is compared with their own scores). Previous TMR studies, which have found significant cuing effects, commonly used 20-25 participants. I plan to include at least 30 participants in this study, after omitting participants who could not complete the task and those who were not sufficiently cued during sleep. Having 30 participants will allow the use of more powerful statistical methods (in accordance with the common rule of thumb derived from the central limit theorem, which states that means based on sample sizes of more than 30 participants can be assumed to follow a normal distribution). I expect the context-related TMR effect (see summary) to be smaller in magnitude relative to the common effect size observed in spatial learning TMR studies (Hedge's g = 0.39 based on a recent meta-analysis). This is why I included a higher sample size. It is important to note that even if this benefit will be of a smaller magnitude, as I expect, it will still be indicative of the underlying neurocognitive process and therefore extremely valuable for our mechanistic understanding of the role of context in sleep. Aiming at a sample size of at least 30 participants and assuming an omission rate of 80%, I therefore plan to have 38 participants altogether.
Here is a brief summary of the procedure:
Stimuli: 16 images of spatial scenes (e.g., a beach) will each be arbitrarily associated with a sound and with four smaller images of objects or animals. Half of the scenes will be randomly designated to the context-reactivation (CR) condition and half to the item-reactivation (IR) condition (see below). The 64 images will each have a unique 2D position on a circular grid presented on the screen.
Training: Participants will first learn to associate each scene with the paired sound up to criterion. Next, they will learn to associate the scene with its four images up to criterion. The last part of training will include two type of learning blocks that will be interspersed. During the spatial-training blocks, in each trial participants will have to place a single image in its correct location. They will then receive feedback to improve. The scene associated with the image will be presented while they learn, but crucially the sound will never be presented for the CR condition scenes. For the IR scenes, the sound will be presented while learning two of the items, but never for the other two.
An alternative design might have divorced the cued items in the CR condition from the scenes altogether; the items could have been associated with novel sounds (i.e., that were not connected to the scene) and not presented along with their scene. However, using such a design would have introduced a confounding factor. The novel sound may have still been associated, to an unknown degree, not only to the item but also to the context to which it belongs. The degree to which this novel sound would be associated with the context would therefore remain uncontrolled and may vary between participants and scenes. Sounds used for item in the IR condition are always additionally associated with the scene. By always having the sounds be associated both with context and - in the IR condition - additionally to items, I substantially reduce any interpretation issues.
During the Sound-scenes blocks, which do not include a spatial component or the smaller images at all, the scenes will be presented with the sounds only for the CR condition scenes (i.e., to balance the number of sound presentations between conditions). These blocks will repeat in an interleaved manner until each participant will reach the pre-set learning criterion on the spatial-task.
Pre-sleep test: After training, participants will be tested on their spatial-memory for all items without exposure to sounds or scenes.
Sleep: During NREM (non-rapid eye movement) sleep, the sounds associated with half of the CR condition scenes and half of the IR condition scenes will be presented unobtrusively. The choice of which sounds to present will be made in a manner that will balance pre-sleep results and therefore enhance the contrast between sleep-related effects for cued and non-cued images.
Post-sleep test: At least 10 minutes after the end of the nap, participants will undergo a test identical to the pre-sleep one. Immediately after, they will be tested on the scene-item and scene-sound associations using both a free-recall and a recognition test. Participants will then be thanked, debriefed, paid and dismissed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Targeted memory reactivation (sounds)This is a within-subject study with a single group of participants |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ---
Key exclusion criteria (2 listed)
- Participants with a history of neurological disorders or of sleep disorders will be excluded.
- Participants who do not believe they would be able to fall asleep in the lab will be excluded.
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 |
|---|---|---|
| Targeted memory reactivation (sounds)I will unobtrusively and repeatedly present learning-related sounds during sleep using speakers. This method was shown to improve memory in various tasks. The sounds will be presented several seconds apart and the volume will be so adjusted as not to disturb the participant's sleep. The sounds will be presented during non-rapid eye movement sleep (sleep stage 2 and slow wave sleep). The sounds presented will be non-congruently related to the scenes in the previous learning task. This manipulation is within-subject - all participants will get it, but different specific sounds will be presented for each individual participant. | Behavioural | Experimental group |
Primary outcome
Change in error rates between pre- and post-sleep for the different conditions
Time frame: Approximately 15 minutes before sleep onset and approximately 15 minutes after sleep offset within the same experimental session
The correct location of an image is compared with the position in which the participant has placed it. Measured in pixels on a computer screen.
Modulation of EEG spectral power following sound/odor presentation
Time frame: During sleep within the experimental session, assessed up to 1.5 hours
Power modulations within the sigma (12-16 Hz), theta (4-8 Hz) and delta (0.5-4 Hz) ranges immediately following sound onset. Measured across different EEG channels.
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 12 Jan 2022.
- Individual participant dataSharing planned: No
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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 Targeted memory reactivation (sounds) in people with Sleep and Consolidation, run by Northwestern University 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 1 inclusion and 2 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 12 Jan 2022. 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?
Change in error rates between pre- and post-sleep for the different conditions (time frame: Approximately 15 minutes before sleep onset and approximately 15 minutes after sleep offset within the same experimental session). The study lists 2 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 12 Jan 2022.