SleepNCT03285880
The Benefits of Naps on Cognitive, Emotional, and Motor Learning in Preschoolers
A study testing Napping in people with Sleep, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
The specific objective of the proposed research is to examine whether naps contribute to immediate and delayed benefits on multiple forms of learning in young children (3-5 yrs). Read more about this study
- Who is it for?
- Ages 33 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Napping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 30 Jun 2022
- 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 33 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- be enrolled in a preschool testing site or available to come into the lab
Who cannot join
- Diagnosis of any sleep disorder(other than mild parasomnia) past or present
- Current use of psychotropic or sleep-altering medications
- traveling beyond 1 time zone within 1 month of testing
- fever or symptoms of respiratory illness at the time of testing
- physical handicap which interferes with assessments (vision, hearing impairment)
- diagnosed developmental disability
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts
Amherst, Massachusetts, 01003
About this study
The specific objective of the proposed research is to examine whether naps contribute to immediate and delayed benefits on multiple forms of learning in young children (3-5 yrs). By probing recall prior to and following mid-day nap or wake intervals, the overarching hypothesis is that recent memories are actively processed (as opposed to passively protected) by a nap, conferring immediate or delayed (24-hrs) benefits on declarative (Aim 1), procedural (Aim 2), and emotional (Aim 3) memories. In two conditions, children will either be nap-promoted or wake-promoted midday. Subsequently, performance will be reassessed that day as well as the following day.
Read the detailed description
The proposed research examines whether naps contribute to immediate and delayed benefits on multiple forms of learning in preschool-aged children (3-5 yrs). By probing recall prior to and following mid-day nap or wake intervals, we will examine immediate memory performance and how it is changed by an interval with a nap compared to if that interval was spent awake. There are three arm, separately assessing declarative (using a storybook learning task), procedural (using a mirror tracing task), and emotional (using an emotional storybook task). All children will participate in a nap and wake condition. On the experimental day, children will learn the task, then be nap or wake promoted (within subject, conditions counterbalanced and separated by 1 week). Subsequently, performance will be reassessed that day as well as the following day. Children will wear an actigraph watch for a 16-day interval surrounding the experimental days in order to access habitual sleep patterns (e.g., nap frequency). A subset of children will complete the experimental days in the sleep laboratory. For these children, sleep will be measured using polysomnography, a montage of electroencepholography, electromyography, and electrooculography electrodes.
- Conditions
- Sleep
- Being tested
- Napping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NappingBehavioural
Children nap during the nap opportunity
| Study group | Role | What they receive |
|---|---|---|
| Declarative memory | Experimental | Napping v. wake effect on a declarative memory task (storybook) Receives: Behavioral: Napping |
| Procedural memory | Experimental | Napping v. wake effect on a procedural memory task (motor sequence learning or mirror tracing) Receives: Behavioral: Napping |
| Emotional memory | Experimental | Napping v. wake effect on an emotional memory task (emotional faces or storybook) Receives: Behavioral: Napping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in memory accuracy
Accuracy on the memory task following the nap compared to before the nap relative to the same memory change measured over an interval spent awake
Measured: 4-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start1 Sep 2017
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: The pandemic halted the study protocol temporarily. We continued to collect what we could but the study ran out of time/funds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Within subject comparison of nap and wake conditions
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Spencer, University of Massachusetts, Amherst
- Investigators
- Rebecca M Spencer, PhD, Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285880
- Sponsor's protocol ID
- R01HL111695
- Status last verified
- Nov 2022
- First submitted
- 14 Sep 2017
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurdziel L, Duclos K, Spencer RM. Sleep spindles in midday naps enhance learning in preschool children. Proc Natl Acad Sci U S A. 2013 Oct 22;110(43):17267-72. doi: 10.1073/pnas.1306418110. Epub 2013 Sep 23.
PubMed 24062429Desrochers PC, Kurdziel LB, Spencer RM. Delayed benefit of naps on motor learning in preschool children. Exp Brain Res. 2016 Mar;234(3):763-72. doi: 10.1007/s00221-015-4506-3. Epub 2015 Dec 8.
PubMed 26645305St Laurent CW, Rasmussen CL, Holmes JF, Cremone-Caira A, Kurdziel LBF, Desrochers PC, Spencer RMC. Associations of activity, sedentary, and sleep behaviors with cognitive and social-emotional health in early childhood. J Act Sedentary Sleep Behav. 2023;2(1):7. doi: 10.1186/s44167-023-00016-6. Epub 2023 Apr 3.
PubMed 38798902
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Naps on Cognitive, Emotional, and Motor Learning in Preschoolers
- ClinicalTrials.gov ID
- NCT03285880
- Acronym / sponsor ID
- R01HL111695
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The pandemic halted the study protocol temporarily. We continued to collect what we could but the study ran out of time/funds.
- Enrolment
- 361 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Sep 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.
The specific objective of the proposed research is to examine whether naps contribute to immediate and delayed benefits on multiple forms of learning in young children (3-5 yrs). By probing recall prior to and following mid-day nap or wake intervals, the overarching hypothesis is that recent memories are actively processed (as opposed to passively protected) by a nap, conferring immediate or delayed (24-hrs) benefits on declarative (Aim 1), procedural (Aim 2), and emotional (Aim 3) memories. In two conditions, children will either be nap-promoted or wake-promoted midday. Subsequently, performance will be reassessed that day as well as the following day.
Detailed description
The proposed research examines whether naps contribute to immediate and delayed benefits on multiple forms of learning in preschool-aged children (3-5 yrs). By probing recall prior to and following mid-day nap or wake intervals, we will examine immediate memory performance and how it is changed by an interval with a nap compared to if that interval was spent awake. There are three arm, separately assessing declarative (using a storybook learning task), procedural (using a mirror tracing task), and emotional (using an emotional storybook task). All children will participate in a nap and wake condition. On the experimental day, children will learn the task, then be nap or wake promoted (within subject, conditions counterbalanced and separated by 1 week). Subsequently, performance will be reassessed that day as well as the following day. Children will wear an actigraph watch for a 16-day interval surrounding the experimental days in order to access habitual sleep patterns (e.g., nap frequency). A subset of children will complete the experimental days in the sleep laboratory. For these children, sleep will be measured using polysomnography, a montage of electroencepholography, electromyography, and electrooculography electrodes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Within subject comparison of nap and wake conditions
| Arm | Type | Receives |
|---|---|---|
| Declarative memory | Experimental | Behavioral: NappingNapping v. wake effect on a declarative memory task (storybook) |
| Procedural memory | Experimental | Behavioral: NappingNapping v. wake effect on a procedural memory task (motor sequence learning or mirror tracing) |
| Emotional memory | Experimental | Behavioral: NappingNapping v. wake effect on an emotional memory task (emotional faces or storybook) |
Who may qualify
- Ages
- 33 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- be enrolled in a preschool testing site or available to come into the lab
Key exclusion criteria (6 listed)
- Diagnosis of any sleep disorder(other than mild parasomnia) past or present
- Current use of psychotropic or sleep-altering medications
- traveling beyond 1 time zone within 1 month of testing
- fever or symptoms of respiratory illness at the time of testing
- physical handicap which interferes with assessments (vision, hearing impairment)
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 |
|---|---|---|
| NappingChildren nap during the nap opportunity | Behavioural | Declarative memory, Emotional memory, Procedural memory |
Primary outcome
Change in memory accuracy
Time frame: 4-5 hours
Accuracy on the memory task following the nap compared to before the nap relative to the same memory change measured over an interval spent awake
Results and safety
The study was stopped early (reason given: The pandemic halted the study protocol temporarily. We continued to collect what we could but the study ran out of time/funds.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Background: PubMed 24062429Kurdziel L, Duclos K, Spencer RM. Sleep spindles in midday naps enhance learning in preschool children. Proc Natl Acad Sci U S A. 2013 Oct 22;110(43):17267-72. doi: 10.1073/pnas.1306418110. Epub 2013 Sep 23.
- Background: PubMed 26645305Desrochers PC, Kurdziel LB, Spencer RM. Delayed benefit of naps on motor learning in preschool children. Exp Brain Res. 2016 Mar;234(3):763-72. doi: 10.1007/s00221-015-4506-3. Epub 2015 Dec 8.
- Derived from this study: PubMed 38798902St Laurent CW, Rasmussen CL, Holmes JF, Cremone-Caira A, Kurdziel LBF, Desrochers PC, Spencer RMC. Associations of activity, sedentary, and sleep behaviors with cognitive and social-emotional health in early childhood. J Act Sedentary Sleep Behav. 2023;2(1):7. doi: 10.1186/s44167-023-00016-6. Epub 2023 Apr 3.
- Lab websiteLink provided by the sponsor.
- 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.
Rebecca M Spencer, PhD principal investigator
University of Massachusetts, Amherst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Napping in people with Sleep, run by University of Massachusetts, Amherst 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 6 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: stopped early, as of the sponsor's last update on 5 Dec 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 was stopped early (reason given: The pandemic halted the study protocol temporarily. We continued to collect what we could but the study ran out of time/funds.). Results are not available in the source record.
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 memory accuracy (time frame: 4-5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03285880, which also lists 3 linked publications.
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 5 Dec 2022.