PICU-related Sleep and Circadian Dysregulation Pilot Study

NCT06505447 | Recruiting

• 1 other identifier: STUDY ID#00008586
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Sleep disruption; circadian rhythm; critical care; pediatrics

Outcome Measures

Primary Outcomes (1)

• Feasibility of monitoring the sleep and circadian rhythm of critically ill children

  The number of days that reliable sleep and CR data are obtained using an actigraph and serial salivary melatonin assays

  PICU Day 1 through 4

Secondary Outcomes (2)

• Feasibility of providing daytime light exposure

  PICU Day 2 through 4

• Feasibility of restricting nutrition to daytime hours

  PICU Day 2 through 4

Study Arms (3)

Phase 1: standard of care

NO INTERVENTION

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.

Phase 2: Daytime light exposure

EXPERIMENTAL

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.

Other: Daytime light exposure

Phase 3: Daytime restricted feeding

EXPERIMENTAL

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.

Other: Daytime restricted feeding

Interventions

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

Also known as: Light therapy

Phase 2: Daytime light exposure

Daytime restricted feeding OTHER

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

Phase 3: Daytime restricted feeding

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

John R. Oishei Children's Hospital

Buffalo, New York, 14203, United States

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 30339549 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Parasomnias; Critical Illness

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Amanda B Hassinger, MD

CONTACT

716-323-0158; albrooks@buffalo.edu

Haiping Qiao, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Pediatric Sleep Medicine

Model Details: Three phase single center pilot study

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)