Recruiting

Observational Study

Sponsor:

State University of New York at Buffalo

Code:

NCT06505447

Conditions

Circadian Dysrhythmia

Sleep Disturbance

Critical Illness

Children, Only

Eligibility Criteria

Sex: All

Age: 3 - 6

Healthy Volunteers: Not accepted

Interventions

Daytime light exposure

Daytime restricted feeding

Study Details

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.

Conditions

Circadian Dysrhythmia

Sleep Disturbance

Critical Illness

Children, Only

Study ID

NCT06505447

Start date

Dec 6, 2024

Status verified date

Mar, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 6

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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

Daytime restricted feeding

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Amanda B Hassinger, MD

716-323-0158albrooks@buffalo.edu

Haiping Qiao, MS

716-323-0055hqiao@upa.chob.edu

Locations

John R. Oishei Children's Hospital

Recruiting

Buffalo, New York, United States, 14203

Contacts

Amanda B Hassinger, MD, MSc

716-323-0370albrooks@buffalo.edu

Haiping Qiao

716-323-0055hqiao@upa.chob.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • Sleep disruption
  • circadian rhythm
  • critical care
  • pediatrics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-03-23.