Longitudinal Investigation of Sleep, Memory, and Brain Development Across the Nap Transition

NCT06351098 | Recruiting DMC

• 1 other identifier: 2024579
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

To examine the relations between sleep (nap transitions, sleep physiology), memory, and brain development longitudinally, the researchers will assess n=180 children (in order to acquire n=152 usable data sets) who are 36-54 months of age and habitual nappers at enrollment. In each wave, the researchers will assess memory, memory change over a nap and equivalent waking interval, sleep physiology of the nap, and brain structure and function (using Magnetic Resonance Imagining or MRI). Additionally, overnight sleep physiology will be assessed in all participants. Waves will take place approximately every 6 months. For all children, three waves will be collected. With these data, the researchers will address the following aims:

• Examine neural markers that predict the sleep transition (Aim 1);
• Examine changes in sleep-dependent memory processing (mnemonic discrimination) over both nap and overnight sleep intervals, across the sleep transition (Aim 2);
• Examine changes in sleep microstructure in both nap and overnight sleep across the sleep transition (Aim 3)
• Examine interrelations among brain, memory and sleep microstructure across the sleep transition (Aim 4)

Conditions

Memory

Keywords

Sleep; Brain development

Outcome Measures

Primary Outcomes (1)

• Memory

  Memory will be assessed using the Mnemonic Similarity Task (MST), before and after nap/wake and overnight sleep. The specific variable of interest is the lure discrimination index, which refers to the probability of "Similar" responses to lure items minus the probability of "Similar" responses given to foils.

  across the nap period, approximately 2.5 hours

Study Arms (1)

Nap

EXPERIMENTAL

Children are nap promoted

Behavioral: nap

Interventions

nap BEHAVIORAL

Children are nap promoted

Nap

Eligibility Criteria

• Age: 36 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• months at the time of enrollment
• must be a habitual napper (defined as napping 5 or more days/week on average for the past month)
• must sleep independently (not bedsharing; in order to maintain consistent sleep not interrupted by others)

You may not qualify if:

• diagnosis of any sleep disorder (other than mild parasomnia which is routine at this age) past or present (Child's Sleep Habit Questionnaire)
• current use of psychotropic or sleep-altering medications (Developmental, Health, and Environment Questionnaire)
• traveling beyond 1 time zone within 1 month prior to testing (phone screening)
• fever or symptoms of respiratory illness at the time of testing (phone screening)
• physical handicap which interferes with assessments (vision, hearing impairment; phone screening)
• diagnosed developmental disability (Developmental, Health, and Environment Questionnaire)
• history of neurological injury such as history of seizures, brain tumor, or stroke (phone screening)
• presence of metal in the body (e.g., implant of any form) or other contraindication for MRI (e.g., claustrophobia, which is rare at this age).
• external influences on nap habits (e.g., inability to nap due to school or caregiver schedule or interfering activities during a typical naptime) including if the child will enroll in full-day kindergarten by the end of the study. Caregivers will also be queried for the presence of interfering activities throughout enrollment (e.g., ecological momentary assessment (or EMA), sleep diaries at each wave).

Sponsors & Collaborators

• University of Maryland, College Park: lead
• University of Massachusetts, Amherst: collaborator

Study Sites (2)

University of Maryland

College Park, Maryland, 20742, United States

RECRUITING

University of Massachusetts

Amherst, Massachusetts, 01003, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Memory will be assessed using the Mnemonic Similarity Task (MST), before and after nap/wake and overnight sleep. The specific variable of interest is the lure discrimination index, which refers to the probability of "Similar" responses to lure items minus the probability of "Similar" responses given to foils.

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 8, 2024
• Study Start: November 5, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available following publication.
• Access Criteria: Data will be made available to researchers pursuant to the Policies of NIH and the University of Maryland.

Locations

US (2)