PICU-related Sleep and Circadian Dysregulation Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorState University of New York at Buffalo
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Child is in end-of-life care
The child is receiving neuromuscular blockade for any reason
Caregiver or parent not at the bedside
Trial design
Treatments tested in this trial
- Daytime light exposure
- Daytime restricted feeding
Treatment groups
30 Participants
are divided into 3 treatment groupsLocations
1John R. Oishei Children's Hospital14203, BuffaloNew York, United States
Sponsors and collaborators
State University of New York at Buffalo
Lead sponsor
Source ClinicalTrials.gov