The Function of Biphasic Sleep in Infants
University of Massachusetts, Amherst · with University of Maryland, College Park · NCT06399939
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 10 mo–1 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- September 1, 2023
- Record last updated
- May 8, 2024
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
This study is designed to investigate developmental changes in naps and nap function on memory from 9 to 15 months of age. Memory is measured by a task in which the experimenter interacts with a toy and the measure of memory is whether the child imitates that action when given the toy. Sleep is assessed with a watch that detects motion which provides an estimate of sleep and a set of electrodes placed on the head that measures brain activity during sleep. Infants are recruited at 9 months and sleep and memory are measured again 3- and 6-months later. At each visit, memory is tested before and after a nap (either the morning or afternoon nap) and naps are recorded with the sleep electrodes.
Being studied: Nap; Wake
Conditions: Sleep Deprivation
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 9 months at the time of enrollment
- normal birthweight (5.5 to 10 lbs) and gestational length (36-41 weeks)
- must be willing and able to return for testing in 3 and 6 months (e.g., no plans to move out of the area)
Exclusion Criteria
- born premature (\<36 weeks gestational age)
- receiving services due to developmental delays
- visual or motor disability
- score \<85 on cognitive and language composite scales and/or \<80 on the average of the two composites of the Bayley Scales of Infant Development Fourth Edition (BSID-IV) administered at the first session.
- Infants' motor development (gross and fine motor) will also be assessed using the BSID-IV, and an adjusted cutoff of 73 will be used to exclude infants with significant motor delays (given the motoric nature of the task).
- traveling beyond 1 time zone within 2 weeks prior to testing (phone screening)
- fever or symptoms of respiratory illness at the time of testing (phone screening)
- physical handicap that interferes with assessments (vision, hearing impairment; phone screening)
- history of neurological injury such as history of seizures, brain tumor, or stroke (phone screening) Parents/guardians of potential participants will be contacted via phone and/or email, at which time the details of the study will be specified and inclusion/exclusion criteria will be reviewed.
Recruiting US locations
University of Massachusetts, Amherst
Amherst, MA 01003
Site contact: Rebecca Spencer, PhD · 413-577-6128 · rspencer@umass.edu
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