Clinical trial NCT06505447: PICU-related Sleep and Circadian Dysregulation Pilot Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Circadian Dysrhythmia
Sleep Disturbance
Critical Illness
Children, Only
Keywords: Sleep disruption
circadian rhythm
critical care
pediatrics
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Three phase single center pilot study
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of monitoring the sleep and circadian rhythm of critically ill children
timeFrame: PICU Day 1 through 4
Secondary outcomes:
measure: Feasibility of providing daytime light exposure
timeFrame: PICU Day 2 through 4
measure: Feasibility of restricting nutrition to daytime hours
timeFrame: PICU Day 2 through 4
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: John R. Oishei Children's Hospital
state: New York
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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 Collaborative in Over 15,000 Adults. Crit Care Med. 2019 Jan;47(1):3-14. doi: 10.1097/CCM.0000000000003482.
citation: 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.
citation: 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.