MemoryHSRNCT06351098
Longitudinal Investigation of Sleep, Memory, and Brain Development Across the Nap Transition
A study testing nap in people with Memory, run by University of Maryland, College Park at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Memory
- What is being tested?
- nap
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Nov 2023to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 36-60 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)
Who cannot join
- 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)
Show all 9Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Massachusetts
Amherst, Massachusetts, 01003
Rebecca MC Spencer, PhD, (413) 577-6128, rspencer@umass.edu
Postdoctoral Fellow, 413-545-4831, preschoolnapstudy@gmail.com
- Recruiting
University of Maryland
College Park, Maryland, 20742
Tracy Riggins, Ph.D., 301-405-5905, riggins@umd.edu
Postdoctoral Fellow, 301-405-5922, napstudy@umd.edu
About this study
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)
Read the detailed description
Child participants will be recruited from databases maintained at each university (see Human Subjects). Initially, parent-report will determine whether the child qualifies as a habitual napper, which will later be confirmed by actigraphy. In each wave, participants will then complete 3 sessions, 3-7 days apart. The first two sessions will consist of nap or wake promotion (counter-balanced, separated by one week) and memory assessments. The third session will consist of a visit to the university for the MRI scan. All of the participants will also have overnight sleep and overnight sleep-dependent memory consolidation assessed on the evenings following the nap/wake sessions. An Actiwatch watch will be given to the participant at the beginning of the first wave. Instructions will be included describing how to put the watch on the child and that the watch should be worn as often as possible. Nap and wake sessions will begin 30 mins prior to the child's typical nap time (if habitual nappers) or approximately 12:30 pm (non-habitual nappers). First, children will complete the encoding and immediate retrieval phases of the mnemonic similarity task. Subsequently, children will either be nap- or wake-promoted. Polysomnography (PSG) will be applied in the nap condition, but timing will be equated in the wake condition. Thirty-minutes following wake (or approximately 3:30 pm for those in the wake group), children will complete the delayed retrieval phase of the mnemonic similarity task.
Participants at both testing sites will also have overnight sleep and memory assessed after the nap and wake sessions. Experimenters will arrive at the participant's house about 30 mins prior the child's typical bedtime. The child will encode a new set of stimuli and complete the immediate retrieval phase of the mnemonic discrimination task. Subsequently, the child will be fitted with PSG. Parents are given instructions on placement of the PSG amplifier during the night and how to remove in the electrodes in the morning. Experimenters will return in the morning to retrieve the equipment and obtain the delayed retrieval phase of the mnemonic similarity task. Approximately 3-7 days after the second visit, children will complete the MRI session. The researchers will attempt to obtain MRI scans in the morning to avoid confounds with nap status. The Actiwatch will also be collected in this session. Children will then be fitted with the Fitbit to wear as often as possible between testing waves. These procedures will be repeated every 6 months for 2-3 waves.
- Conditions
- Memory
- Being tested
- nap
- Keywords
- Sleep, Brain development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
napBehavioural
Children are nap promoted
| Study group | Role | What they receive |
|---|---|---|
| Nap | Experimental | Children are nap promoted Receives: Behavioral: nap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: across the nap period, approximately 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start5 Nov 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MemoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Amherst
- Responsible party
- Principal investigator, Tracy Riggins, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351098
- Sponsor's protocol ID
- 2024579
- Acronym
- HSR
- Status last verified
- Jun 2026
- First submitted
- 15 Mar 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data collected through the proposed work will be made available to researchers pursuant to the Policies of NIH and the University of Maryland. Access to data will be granted upon request to qualified academic investigators for non-commercial research. Research resources generated with funds from this grant will be freely distributed, as available, to qualified academic investigators for noncommercial research upon request. Finally, following publication, raw MRI and PSG data will also be made available on the National Sleep Research Resource (NSRR), which is supported by the National Heart, Lung, and Blood Institute. The NSRR offers access free-of-charge to collections of de-identified physiological signals and clinical data elements from well-characterized research cohorts and clinical trials. If MRI data prove difficult to upload to NSRR, we will work with NHLBI Program to identify a supplemental or additional repository for the MRI data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Investigation of Sleep, Memory, and Brain Development Across the Nap Transition
- ClinicalTrials.gov ID
- NCT06351098
- Acronym / sponsor ID
- HSR / 2024579
- Conditions
- Memory
- Keywords
- Sleep, Brain development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- University of Massachusetts, Amherst
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Child participants will be recruited from databases maintained at each university (see Human Subjects). Initially, parent-report will determine whether the child qualifies as a habitual napper, which will later be confirmed by actigraphy. In each wave, participants will then complete 3 sessions, 3-7 days apart. The first two sessions will consist of nap or wake promotion (counter-balanced, separated by one week) and memory assessments. The third session will consist of a visit to the university for the MRI scan. All of the participants will also have overnight sleep and overnight sleep-dependent memory consolidation assessed on the evenings following the nap/wake sessions. An Actiwatch watch will be given to the participant at the beginning of the first wave. Instructions will be included describing how to put the watch on the child and that the watch should be worn as often as possible. Nap and wake sessions will begin 30 mins prior to the child's typical nap time (if habitual nappers) or approximately 12:30 pm (non-habitual nappers). First, children will complete the encoding and immediate retrieval phases of the mnemonic similarity task. Subsequently, children will either be nap- or wake-promoted. Polysomnography (PSG) will be applied in the nap condition, but timing will be equated in the wake condition. Thirty-minutes following wake (or approximately 3:30 pm for those in the wake group), children will complete the delayed retrieval phase of the mnemonic similarity task.
Participants at both testing sites will also have overnight sleep and memory assessed after the nap and wake sessions. Experimenters will arrive at the participant's house about 30 mins prior the child's typical bedtime. The child will encode a new set of stimuli and complete the immediate retrieval phase of the mnemonic discrimination task. Subsequently, the child will be fitted with PSG. Parents are given instructions on placement of the PSG amplifier during the night and how to remove in the electrodes in the morning. Experimenters will return in the morning to retrieve the equipment and obtain the delayed retrieval phase of the mnemonic similarity task. Approximately 3-7 days after the second visit, children will complete the MRI session. The researchers will attempt to obtain MRI scans in the morning to avoid confounds with nap status. The Actiwatch will also be collected in this session. Children will then be fitted with the Fitbit to wear as often as possible between testing waves. These procedures will be repeated every 6 months for 2-3 waves.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nap | Experimental | Behavioral: napChildren are nap promoted |
Who may qualify
- Ages
- 36 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 36-60 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| napChildren are nap promoted | Behavioural | Nap |
Primary outcome
Memory
Time frame: across the nap period, approximately 2.5 hours
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified data collected through the proposed work will be made available to researchers pursuant to the Policies of NIH and the University of Maryland. Access to data will be granted upon request to qualified academic investigators for non-commercial research. Research resources generated with funds from this grant will be freely distributed, as available, to qualified academic investigators for noncommercial research upon request. Finally, following publication, raw MRI and PSG data will also be made available on the National Sleep Research Resource (NSRR), which is supported by the National Heart, Lung, and Blood Institute. The NSRR offers access free-of-charge to collections of de-identified physiological signals and clinical data elements from well-characterized research cohorts and clinical trials. If MRI data prove difficult to upload to NSRR, we will work with NHLBI Program to identify a supplemental or additional repository for the MRI data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nap in people with Memory, run by University of Maryland, College Park at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory (time frame: across the nap period, approximately 2.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.