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PICU-related Sleep and Circadian Dysregulation Pilot Study

PICU-related Sleep and Circadian Dysregulation Pilot Study

Recruiting
3-6 years
All
Phase N/A

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Overview

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.

Description

Several of the identified sleep disruptors in a pediatric intensive care environment may not be modifiable, including restricting feeding to daytime hours and providing normal daytime light exposure. This study aims to measure the feasibility of measuring sleep and circadian patterns in a PICU during routine care and during 2 focused sleep promotion interventions: timed daytime light exposure (DLE) and daytime feeding restriction (DFR). The overall objective of this study is to test the hypothesis that, with multi-disciplinary efforts, providing chronotherapeutic care will be feasible and that reliably measuring sleep patterns and the CR of critically ill children with timed salivary melatonin assays and actigraphy is possible.

Eligibility

Inclusion Criteria:

  1. Child age 3 to 6 years old on the day of PICU admission
  2. English-speaking parent at the bedside
  3. Child expected to remain in the PICU over 24 to 48 hours

Exclusion Criteria:

  1. Child is in end-of-life care
  2. The child is receiving neuromuscular blockade for any reason
  3. Caregiver or parent not at the bedside

Study details
    Circadian Dysrhythmia
    Sleep Disturbance
    Critical Illness
    Children
    Only

NCT06505447

State University of New York at Buffalo

15 October 2025

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