- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04758663
The Role of Naps and Overnight Sleep on Cognitive Learning in Preschoolers
May 12, 2021 updated by: Rebecca Spencer, University of Massachusetts, Amherst
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
40
Phase
- 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 Contact
- Name: Sanna Lokhandwala, MS
- Phone Number: 8323821611
- Email: slokhandwala@umass.edu
Study Contact Backup
- Name: Rebecca M Spencer, PhD
- Phone Number: 413-548-5661
- Email: rspencer@umass.edu
Study Locations
-
-
Massachusetts
-
Amherst, Massachusetts, United States, 01003
- Recruiting
- University of Massachusetts
-
Contact:
- Rebecca M Spencer, PhD
- Phone Number: 413-548-5661
- Email: rspencer@umass.edu
-
-
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
Ages Eligible for Study
2 years to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Declarative memory
Napping v. wake effect on declarative memory in habitual and non-habitual nappers.
|
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.
|
|
Experimental: Overnight Physiology
Napping v. wake effect on overnight physiology in habitual and non-habitual nappers.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
9-11 hours of sleep overnight
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in memory accuracy
Time Frame: 2-3 hours/24 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.
Further, accuracy on the memory task 24hrs later compared to before the nap/wake interval.
|
2-3 hours/24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 12, 2021
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
February 12, 2021
First Submitted That Met QC Criteria
February 12, 2021
First Posted (Actual)
February 17, 2021
Study Record Updates
Last Update Posted (Actual)
May 13, 2021
Last Update Submitted That Met QC Criteria
May 12, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2021-2488
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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