Investigating sleep and circadian rhythm in critically ill children
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
This study is testing if giving critically ill children in the PICU more light during the day and limiting their food to daytime hours can help improve their sleep patterns.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 6 Years |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06505447 on ClinicalTrials.gov |
What this trial studies
This pilot trial focuses on critically ill children aged 3 to 6 years in a pediatric intensive care unit (PICU) to assess the feasibility of measuring their sleep and circadian rhythms using actigraphy and salivary melatonin levels. The study will implement two interventions: providing daytime light exposure and restricting nutrition to daytime hours. By evaluating these interventions, the research aims to determine if chronotherapeutic care can be effectively integrated into routine PICU management. The ultimate goal is to improve the understanding of sleep patterns in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 6 years who are admitted to the PICU and are expected to stay for at least 24 to 48 hours.
Not a fit: Patients receiving end-of-life care or those on neuromuscular blockade will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality and circadian regulation in critically ill children, enhancing their recovery process.
How similar studies have performed: While the approach of using light exposure and feeding restrictions is innovative, similar studies have shown promise in improving sleep in critical care settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Buffalo, New York
- John R. Oishei Children's Hospital — Buffalo, New York, United States (Recruiting)
Study contacts
- Study coordinator: Amanda B Hassinger, MD
- Email: albrooks@buffalo.edu
- Phone: 716-323-0158
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.