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NCT Number: NCT06505447

PICU-related Sleep and Circadian Dysregulation Pilot Study

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.

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Key information

Conditions

Circadian Dysrhythmia Children, Only Critical Illness Disease Attributes Mental Disorders Nervous System Diseases Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

Other names: Light therapy

Daytime restricted feeding

Other

Participant's nutrition, parenteral or enteral, will be restricted to the hours when they are normally awake at home.

Primary outcomes

  1. Feasibility of monitoring the sleep and circadian rhythm of critically ill children

    Time frame: 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 outcomes

  1. Feasibility of providing daytime light exposure

    Time frame: 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

  2. Feasibility of restricting nutrition to daytime hours

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda B Hassinger, MD

CONTACT

[email protected]

716-323-0158

Haiping Qiao, MS

CONTACT

[email protected]

716-323-0055

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

A Three-phase Pilot Study of the Feasibility of the Measurement and Promotion of Sleep and the Circadian Rhythm in a Pediatric Intensive Care Unit

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 17, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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