NCT06505447 · State University of New York at Buffalo
PICU-related Sleep and Circadian Dysregulation Pilot Study
What this study is about
A single center pilot trial investigating the feasibility of using actigraphy and salivary melatonin levels to measure the sleep and circadian rhythm of critically ill children aged 3 to 6 years old. This study will also measure the feasibility of providing daytime light exposure as well as restricting all provided nutrition to during daytime hours.
View original scientific description
A single center pilot trial investigating the feasibility of using actigraphy and salivary melatonin levels to measure the sleep and circadian rhythm of critically ill children aged 3 to 6 years old. This study will also measure the feasibility of providing daytime light exposure as well as restricting all provided nutrition to during daytime hours.
Interventions
OTHER
Daytime light exposure
Participants will be exposed to a 10,000 lux light source within 3 feet of their face/eyes to promote the natural circadian rhythm for 2-3 hours from 10am to 12/1pm depending on their nap time at home
OTHER
Daytime restricted feeding
Participant's nutrition, parenteral or enteral, will be restricted to the hours when they are normally awake at home.
Primary outcome measures
Feasibility of monitoring the sleep and circadian rhythm of critically ill children
Time frame: PICU Day 1 through 4
The number of days that reliable sleep and CR data are obtained using an actigraph and serial salivary melatonin assays
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
- Child age 3 to 6 years old on the day of PICU admission
- English-speaking parent at the bedside
- Child expected to remain in the PICU over 24 to 48 hours
Exclusion criteria
- Child is in end-of-life care
- The child is receiving neuromuscular blockade for any reason
- Caregiver or parent not at the bedside
Where
- Buffalo, New York
Related conditions & keywords
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 Mar 23, 2026 · Source of record for eligibility and locations