NCT04758663

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 12, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

February 12, 2021

Last Update Submit

May 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    9-11 hours of sleep overnight

Secondary Outcomes (1)

  • Change in memory accuracy

    2-3 hours/24 hours

Study Arms (2)

Declarative memory

EXPERIMENTAL

Napping v. wake effect on declarative memory in habitual and non-habitual nappers.

Behavioral: Nap/wake conditions on memory

Overnight Physiology

EXPERIMENTAL

Napping v. wake effect on overnight physiology in habitual and non-habitual nappers.

Behavioral: Nap/wake conditions on overnight physiology

Interventions

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.

Declarative memory

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.

Overnight Physiology

Eligibility Criteria

Age33 Months - 71 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts

Amherst, Massachusetts, 01003, United States

RECRUITING

Study Officials

  • Rebecca M Spencer, PhD

    University of Massachusetts, Amherst

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanna Lokhandwala, MS

CONTACT

Rebecca M Spencer, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Within-subject; participants/experimenters are aware of conditions
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Within subject comparison of nap/overnight and wake/overnight conditions in habitual and non-habitual nappers
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychological and Brain Sciences

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 17, 2021

Study Start

April 12, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2023

Last Updated

May 13, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations