PICU-related Sleep and Circadian Dysregulation Pilot Study

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT06505447
Status
Recruiting
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Conditions

  • Children, Only
  • Circadian Dysrhythmia
  • Critical Illness
  • Sleep Disturbance

Eligibility Criteria

Sex
ALL
Age
3 Years - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • Daytime light exposure — OTHER
    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
  • Daytime restricted feeding — OTHER
    Participant's nutrition, parenteral or enteral, will be restricted to the hours when they are normally awake at home.

Study Details

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.

Key Dates

Start date
Dec 6, 2024
Status verified
Mar 2026
Primary completion
Dec 30, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • No Intervention: Phase 1: standard of care
    10 children will be enrolled in the first phase related to determining if using actigraphy and timed saliva melatonin samples can be a feasible way to measure the sleep and circadian rhythm of critically ill children aged 3 to 6 years old while they receive routine critical care.
  • Experimental: Phase 2: Daytime light exposure
    10 children will undergo the same sleep monitoring and salivary melatonin sampling as phase 1 while receiving timed exposure to a light box of 10,000 lux within 3 feet of their hospital bed for PICU days #2, 3 and 4.
  • Experimental: Phase 3: Daytime restricted feeding
    10 children will undergo the same sleep monitoring and salivary melatonin sampling as phase 1 while attempting to limit all nutrition (parental or enteral) to being provided during the normal hours that the child is awake at home on PICU days #2, 3, 4.

Primary Outcome Measure

Feasibility of monitoring the sleep and circadian rhythm of critically ill children [ Time Frame: PICU Day 1 through 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
John R. Oishei Children's HospitalBuffaloNew York14203
Amanda B Hassinger, MD, MSc
[email protected]
716-323-0370
Haiping Qiao
[email protected]
716-323-0055

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By research site
John R. Oishei Children's Hospital· Buffalo, NY

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