SleepNCT04758663
The Role of Naps and Overnight Sleep on Cognitive Learning in Preschoolers
A study testing Nap/wake conditions on memory and Nap/wake conditions on overnight physiology in people with Sleep, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
The goal of this research is to understand the role of sleep on memory function in early childhood. Specifically, we seek to examine how promoted naps vs. promoted waking in habitual and non-habitual napping children may impact overnight sleep physiology and subsequent memory consolidation. Read more about this study
- Who is it for?
- Ages 33 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Nap/wake conditions on memory and Nap/wake conditions on overnight physiology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2021to 30 Jun 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 33 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Family lives within 30 miles of UMass Amherst
- Is 33-71 months at the time of enrollment
- Meets the definition of a habitual (5+ naps/week) or non-habitual (<2 naps/week) napper
- Normal or corrected-to-normal vision and hearing
- Access to a computer with an internet connection for online sessions with the research team.
Who cannot join
- Diagnosis of any sleep disorder (other than mild parasomnia which is routine at this age) past or present
- Current use of psychotropic or sleep-altering medications
- Traveling beyond 1 time zone within 1 month of participation
- Fever or symptoms of respiratory illness at the time of participation
- Diagnosed developmental disability
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Massachusetts
Amherst, Massachusetts, 01003
Rebecca M Spencer, PhD, 413-548-5661, rspencer@umass.edu
About this study
The goal of this research is to understand the role of sleep on memory function in early childhood. Specifically, we seek to examine how promoted naps vs. promoted waking in habitual and non-habitual napping children may impact overnight sleep physiology and subsequent memory consolidation.
Read the detailed description
With time spent awake, sleepiness increases (i.e., sleep pressure; Borbely, 1982). In young adults, naps following sleep deprivation have significantly elevated slow wave activity (SWA; 1-4 Hz) relative to naps following normal overnight sleep (Werth et al., 1996). Similarly in preschool children, overnight sleep following nap deprivation yields significantly greater SWS relative to when a nap was taken earlier in the day (Lassonde et al., 2016). This impact on subsequent sleep physiology suggests that naps may be an extension of overnight sleep. How napping status (i.e., habitual and non-habitual napping) impacts overnight sleep physiology and subsequent memory consolidation is unknown. Thus, this study aims to investigate how napping vs. staying awake in habitual and non-habitual napping children may impact overnight sleep physiology and subsequent memory consolidation.
- Conditions
- Sleep
- Being tested
- Nap/wake conditions on memory, Nap/wake conditions on overnight physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nap/wake conditions on memoryBehavioural
Habitual and non-habitual napping children will complete a two conditions-a nap condition where they are encouraged to nap in the afternoon and a wake condition where instead of napping, they spend an equal amount of time awake engaging in quiet activities.
Nap/wake conditions on overnight physiologyBehavioural
Habitual and non-habitual napping children will complete a two conditions-a nap condition where they are encouraged to nap in the afternoon and a wake condition where instead of napping, they spend an equal amount of time awake engaging in quiet activities. On the nights of the nap and wake conditions, physiology will be recorded in habitual and non-habitual nappers.
| Study group | Role | What they receive |
|---|---|---|
| Declarative memory | Experimental | Napping v. wake effect on declarative memory in habitual and non-habitual nappers. Receives: Behavioral: Nap/wake conditions on memory |
| Overnight Physiology | Experimental | Napping v. wake effect on overnight physiology in habitual and non-habitual nappers. Receives: Behavioral: Nap/wake conditions on overnight physiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overnight sleep physiology
Amount of slow wave activity and other non-REM sleep features in overnight sleep following a day where a nap was involved compared to when there was no nap earlier in the day.
Measured: 9-11 hours of sleep overnight
Secondary outcomes (1)
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. Further, accuracy on the memory task 24hrs later compared to before the nap/wake interval.
Measured: 2-3 hours/24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start12 Apr 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
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.
- 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/overnight and wake/overnight conditions in habitual and non-habitual nappers
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
- NCT04758663
- Sponsor's protocol ID
- 2021-2488
- Status last verified
- May 2021
- First submitted
- 12 Feb 2021
- Last updated
- 13 May 2021
- 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 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Naps and Overnight Sleep on Cognitive Learning in Preschoolers
- ClinicalTrials.gov ID
- NCT04758663
- Acronym / sponsor ID
- 2021-2488
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 17 Feb 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 goal of this research is to understand the role of sleep on memory function in early childhood. Specifically, we seek to examine how promoted naps vs. promoted waking in habitual and non-habitual napping children may impact overnight sleep physiology and subsequent memory consolidation.
Detailed description
With time spent awake, sleepiness increases (i.e., sleep pressure; Borbely, 1982). In young adults, naps following sleep deprivation have significantly elevated slow wave activity (SWA; 1-4 Hz) relative to naps following normal overnight sleep (Werth et al., 1996). Similarly in preschool children, overnight sleep following nap deprivation yields significantly greater SWS relative to when a nap was taken earlier in the day (Lassonde et al., 2016). This impact on subsequent sleep physiology suggests that naps may be an extension of overnight sleep. How napping status (i.e., habitual and non-habitual napping) impacts overnight sleep physiology and subsequent memory consolidation is unknown. Thus, this study aims to investigate how napping vs. staying awake in habitual and non-habitual napping children may impact overnight sleep physiology and subsequent memory consolidation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within subject comparison of nap/overnight and wake/overnight conditions in habitual and non-habitual nappers
| Arm | Type | Receives |
|---|---|---|
| Declarative memory | Experimental | Behavioral: Nap/wake conditions on memoryNapping v. wake effect on declarative memory in habitual and non-habitual nappers. |
| Overnight Physiology | Experimental | Behavioral: Nap/wake conditions on overnight physiologyNapping v. wake effect on overnight physiology in habitual and non-habitual nappers. |
Who may qualify
- Ages
- 33 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Family lives within 30 miles of UMass Amherst
- Is 33-71 months at the time of enrollment
- Meets the definition of a habitual (5+ naps/week) or non-habitual (<2 naps/week) napper
- Normal or corrected-to-normal vision and hearing
- Access to a computer with an internet connection for online sessions with the research team.
Key exclusion criteria (5 listed)
- Diagnosis of any sleep disorder (other than mild parasomnia which is routine at this age) past or present
- Current use of psychotropic or sleep-altering medications
- Traveling beyond 1 time zone within 1 month of participation
- Fever or symptoms of respiratory illness at the time of participation
- Diagnosed developmental disability
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 |
|---|---|---|
| Nap/wake conditions on memoryHabitual and non-habitual napping children will complete a two conditions-a nap condition where they are encouraged to nap in the afternoon and a wake condition where instead of napping, they spend an equal amount of time awake engaging in quiet activities. | Behavioural | Declarative memory |
| Nap/wake conditions on overnight physiologyHabitual and non-habitual napping children will complete a two conditions-a nap condition where they are encouraged to nap in the afternoon and a wake condition where instead of napping, they spend an equal amount of time awake engaging in quiet activities. On the nights of the nap and wake conditions, physiology will be recorded in habitual and non-habitual nappers. | Behavioural | Overnight Physiology |
Primary outcome
Overnight sleep physiology
Time frame: 9-11 hours of sleep overnight
Amount of slow wave activity and other non-REM sleep features in overnight sleep following a day where a nap was involved compared to when there was no nap earlier in the day.
1 secondary outcome
Change in memory accuracy
Time frame: 2-3 hours/24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- 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 Nap/wake conditions on memory and Nap/wake conditions on overnight physiology 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanna Lokhandwala, MS (8323821611, slokhandwala@umass.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overnight sleep physiology (time frame: 9-11 hours of sleep overnight). 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 13 May 2021.