PICU-related Sleep and Circadian Dysregulation Pilot Study

Not Applicable

Recruiting

• Conditions: Sleep Disturbance; Children, Only; Circadian Dysrhythmia; Critical Illness
• Interventions: Other: Daytime light exposure; Other: Daytime restricted feeding

• Registration Number: NCT06505447
• Lead Sponsor: State University of New York at Buffalo

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-17
• Status Verified: 2024-12
• Study Start: 2024-12-06
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30
• Primary Completion: 2025-04-30
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 2: Daytime light exposure	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.
Phase 3: Daytime restricted feeding	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 Measures

Name	Time	Method
Feasibility of monitoring the sleep and circadian rhythm of critically ill children	PICU Day 1 through 4	The number of days that reliable sleep and CR data are obtained using an actigraph and serial salivary melatonin assays

Secondary Outcome Measures

Name	Time	Method
Feasibility of providing daytime light exposure	PICU Day 2 through 4	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
Feasibility of restricting nutrition to daytime hours	PICU Day 2 through 4	. 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

Trial Locations

Locations (1)

John R. Oishei Children's Hospital; 🇺🇸 Buffalo, New York, United States