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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Daytime light exposure
Other interventionParticipants 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
Daytime restricted feeding
Other interventionParticipant's nutrition, parenteral or enteral, will be restricted to the hours when they are normally awake at home.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Phase 1: standard of careNo intervention 0 interventions
Group B: Phase 2: Daytime light exposureExperimental treatment 1 intervention
Group C: Phase 3: Daytime restricted feedingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of monitoring the sleep and circadian rhythm of critically ill children
The number of days that reliable sleep and CR data are obtained using an actigraph and serial salivary melatonin assays
Time frame
PICU Day 1 through 4Secondary outcomes
1
Feasibility of providing daytime light exposure
Feasibility will be defined by the percentage of days when DLE was implemented and the average hours of DLE provided using a bedside DLE log
Time frame
PICU Day 2 through 42
Feasibility of restricting nutrition to daytime hours
. The feasibility of daytime restricted feeding will be determined by the percentage of enteral or parenteral nutrition that was provided on each study day outside of the child's daytime feeding period determined by the Intake and Output records in the EMR
Time frame
PICU Day 2 through 4Sponsors and contacts
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Source ClinicalTrials.gov