PICU-related Sleep and Circadian Dysregulation Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Daytime light exposure, Daytime restricted feeding.
- Who it may be relevant to
- Registry conditions: Circadian Dysrhythmia, Sleep Disturbance, Critical Illness, Children, Only. Basic parameters: 3 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
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.
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.
Interventions
- Other 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 - Other Daytime restricted feeding
Participant's nutrition, parenteral or enteral, will be restricted to the hours when they are normally awake at home.
Primary outcome measures
- Feasibility of monitoring the sleep and circadian rhythm of critically ill children [Time frame: PICU Day 1 through 4]
Secondary outcome measures (2)
- Feasibility of providing daytime light exposure [Time frame: PICU Day 2 through 4]
- Feasibility of restricting nutrition to daytime hours [Time frame: PICU Day 2 through 4]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- John R. Oishei Children's Hospital — Buffalo
Publications
- Traube C, Silver G, Gerber LM, Kaur S, Mauer EA, Kerson A, Joyce C, Greenwald BM. Delirium and Mortality in Critically Ill Children: Epidemiology and Outcomes of Pediatric Delirium. Crit Care Med. 2017 May;45(5):891-898. doi: 10.1097/CCM.0000000000002324. PMID 28288026
- Kamdar BB, Kamdar BB, Needham DM. Bundling sleep promotion with delirium prevention: ready for prime time? Anaesthesia. 2014 Jun;69(6):527-31. doi: 10.1111/anae.12686. No abstract available. PMID 24813131
- Kudchadkar SR, Aljohani OA, Punjabi NM. Sleep of critically ill children in the pediatric intensive care unit: a systematic review. Sleep Med Rev. 2014 Apr;18(2):103-10. doi: 10.1016/j.smrv.2013.02.002. Epub 2013 May 21. PMID 23702219
- Pun BT, Balas MC, Barnes-Daly MA, Thompson JL, Aldrich JM, Barr J, Byrum D, Carson SS, Devlin JW, Engel HJ, Esbrook CL, Hargett KD, Harmon L, Hielsberg C, Jackson JC, Kelly TL, Kumar V, Millner L, Morse A, Perme CS, Posa PJ, Puntillo KA, Schweickert WD, Stollings JL, Tan A, D'Agostino McGowan L, Ely EW. Caring for Critically Ill Patients with the ABCDEF Bundle: Results of the ICU Liberation Collab PMID 30339549
- Berger J, Zaidi M, Halferty I, Kudchadkar SR. Sleep in the Hospitalized Child: A Contemporary Review. Chest. 2021 Sep;160(3):1064-1074. doi: 10.1016/j.chest.2021.04.024. Epub 2021 Apr 22. PMID 33895129
- Hassinger AB, Mody K, Gomez R, Wrotniak BH, Falkowski K, Breuer R, Mennie C, Flagg LK. Validation of the Survey of Sleep Quality in the Pediatric Intensive Care Unit (SSqPICU). J Clin Sleep Med. 2024 Aug 1;20(8):1251-1258. doi: 10.5664/jcsm.11116. PMID 38456806
Identifiers
NCT: NCT06505447 · STUDY ID#00008586