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PICU-related Sleep and Circadian Dysregulation Pilot Study

NCT06505447 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-23

No results posted yet for this study

Summary

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.

Conditions

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

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.

Sponsors & Collaborators

  • State University of New York at Buffalo

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-06
Primary Completion
2026-12-30
Completion
2027-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06505447 on ClinicalTrials.gov