NCT06351098 Longitudinal Investigation of Sleep, Memory, and Brain Development Across the Nap Transition
| NCT ID | NCT06351098 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, College Park |
| Condition | Memory |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-11-05 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2023-11-05 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
Inclusion 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) Exclusion Criteria: 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).
Frequently Asked Questions
Who can join the NCT06351098 clinical trial?
This trial is open to participants of all sexes, aged 36 Months or older, up to 60 Months, studying Memory. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06351098 currently recruiting?
Yes, NCT06351098 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Maryland, College Park to inquire about joining.
Where is the NCT06351098 trial being conducted?
This trial is being conducted at College Park, United States, Amherst, United States.
Who is sponsoring the NCT06351098 clinical trial?
NCT06351098 is sponsored by University of Maryland, College Park. The trial plans to enroll 180 participants.