NCT06399939 · University of Massachusetts, Amherst
The Function of Biphasic Sleep in Infants
What this 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Amherst, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2024 · Source of record for eligibility and locations