RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2023-11-05

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06351098

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.

Ages Eligible for Study:36 Months to 60 Months

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. 36-60 months at the time of enrollment 2. must be a habitual napper (defined as napping 5 or more days/week on average for the past month) 3. must sleep independently (not bedsharing; in order to maintain consistent sleep not interrupted by others)	1. diagnosis of any sleep disorder (other than mild parasomnia which is routine at this age) past or present (Child's Sleep Habit Questionnaire) 2. current use of psychotropic or sleep-altering medications (Developmental, Health, and Environment Questionnaire) 3. traveling beyond 1 time zone within 1 month prior to testing (phone screening) 4. fever or symptoms of respiratory illness at the time of testing (phone screening) 5. physical handicap which interferes with assessments (vision, hearing impairment; phone screening) 6. diagnosed developmental disability (Developmental, Health, and Environment Questionnaire) 7. history of neurological injury such as history of seizures, brain tumor, or stroke (phone screening) 8. 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). 9. 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).

Inclusion Criteria

Exclusion Criteria

1. 36-60 months at the time of enrollment
2. must be a habitual napper (defined as napping 5 or more days/week on average for the past month)
3. must sleep independently (not bedsharing; in order to maintain consistent sleep not interrupted by others)

1. diagnosis of any sleep disorder (other than mild parasomnia which is routine at this age) past or present (Child's Sleep Habit Questionnaire)
2. current use of psychotropic or sleep-altering medications (Developmental, Health, and Environment Questionnaire)
3. traveling beyond 1 time zone within 1 month prior to testing (phone screening)
4. fever or symptoms of respiratory illness at the time of testing (phone screening)
5. physical handicap which interferes with assessments (vision, hearing impairment; phone screening)
6. diagnosed developmental disability (Developmental, Health, and Environment Questionnaire)
7. history of neurological injury such as history of seizures, brain tumor, or stroke (phone screening)
8. 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).
9. 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).

Contacts and Locations

Study Locations (Sites)

University of Maryland

College Park, Maryland, 20742

United States

University of Massachusetts

Amherst, Massachusetts, 01003

United States

Collaborators and Investigators

Sponsor: University of Maryland, College Park

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 Registration Dates

Study Start Date2023-11-05

Study Completion Date2028-06

Study Record Updates

Study Start Date2023-11-05

Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

Sleep
Brain development

Additional Relevant MeSH Terms

Memory