PICU-related Sleep and Circadian Dysregulation Pilot Study

University at Buffalo (UB)

Status: Enrolling

Conditions: Circadian Dysrhythmia; Critical Illness; Children, Only; Sleep Disturbance

Treatments: Other: Daytime light exposure; Other: Daytime restricted feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT06505447

STUDY ID#00008586

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Phase 1: standard of care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Daytime light exposure

Phase 3: Daytime restricted feeding

Experimental group

Description:

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.

Treatment:

Other: Daytime restricted feeding