Daytime Light Exposure for Insomnia in Critically Ill Children

Overseen By Haiping Qiao, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: End-of-life care, Neuromuscular blockade, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new methods to help critically ill children aged 3 to 6 sleep better in the hospital. Researchers will examine whether exposing children to bright light during the day (daytime light exposure) and providing food only during typical waking hours (daytime restricted feeding) can enhance their sleep and body clock rhythms. The trial will test these methods by first monitoring current sleep patterns and then implementing the light exposure and feeding schedule in different groups. Children admitted to the pediatric intensive care unit (PICU) and expected to stay for more than a day may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve hospital care for children.

Do I need to stop my child's current medications for the trial?

The trial information does not specify whether your child needs to stop taking current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that daytime light exposure and daytime restricted feeding are safe for critically ill children?

Research has shown that exposure to daylight during the day is generally safe and can improve sleep quality. For example, one study found that office workers who received more daylight felt better and slept better. Although little information exists on how daylight affects children in hospitals, no harm has been reported in these settings.

Regarding eating only during the day, the evidence remains unclear. Some studies suggest it might aid metabolism and improve how sick children handle food. However, concerns exist about its impact on nutrition. While no strong evidence of harm has emerged, more research is necessary.

Overall, both treatments appear well-tolerated, but information is limited, particularly concerning restricted feeding in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative non-pharmacological approaches to manage insomnia in critically ill children. Unlike standard care options, which often involve medications to aid sleep, this trial investigates the effects of daytime light exposure and restricted feeding schedules. Daytime light exposure uses a light box to potentially reset the circadian rhythm, while restricted feeding aligns nutritional intake with the child's natural wake hours to support better sleep patterns. These methods could offer safer, drug-free alternatives to improve sleep in young patients, which is why researchers are eager to see the outcomes.

What evidence suggests that this trial's treatments could be effective for insomnia in critically ill children?

Research shows that enough daylight can improve sleep in seriously ill children by adjusting their body clocks. In this trial, one group of children will receive daytime light exposure, with bright light during the day. Studies have found this can lead to less disrupted sleep and better sleep quality, which has been linked to improved brain function in children.

Another group will undergo daytime restricted feeding. Studies suggest that regular meals when children are naturally awake can support better body rhythms, potentially improving sleep. Research indicates that eating at set times might stabilize blood sugar levels and lower infection risk in seriously ill patients. Both treatments in this trial aim to enhance sleep and overall health in children during serious illness. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for critically ill children aged 3 to 6 who are admitted to the Pediatric Intensive Care Unit (PICU) and expected to stay at least 24-48 hours. A parent who speaks English must be present. It's not specified who can't join, but typically those with conditions affecting sleep or circadian rhythms might be excluded.

Inclusion Criteria

My child is between 3 to 6 years old and was admitted to the PICU.

My child is expected to stay in the intensive care unit for 1-2 days.

I have an English-speaking parent with me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Standard of Care

Participants receive routine critical care while feasibility of sleep and circadian rhythm measurement is assessed using actigraphy and salivary melatonin samples

4 days

Inpatient stay

Daytime Light Exposure

Participants receive timed exposure to a light box of 10,000 lux for PICU days #2, 3, and 4 while undergoing sleep monitoring and salivary melatonin sampling

3 days

Inpatient stay

Daytime Restricted Feeding

Participants have all nutrition restricted to daytime hours for PICU days #2, 3, and 4 while undergoing sleep monitoring and salivary melatonin sampling

3 days

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after interventions

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Daytime light exposure
• Daytime restricted feeding

Trial Overview

The study is testing if it's possible to measure sleep patterns and body clock rhythms using activity trackers and saliva tests for melatonin in these young patients. It also looks at whether exposing them to light during the day and only feeding them during daylight hours could help regulate their sleep-wake cycles.

How Is the Trial Designed?

Group I: Phase 3: Daytime restricted feeding Experimental Treatment 1 Intervention

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.

Group II: Phase 2: Daytime light exposure Experimental Treatment 1 Intervention

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.

Group III: Phase 1: standard of care Active Control 1 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.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Published Research Related to This Trial

The RESTORE Resilience (R2) program aims to improve circadian rhythms in critically ill children by implementing a comprehensive care bundle, including routines, lighting adjustments, and early mobility, in a study involving 60 pediatric patients requiring mechanical ventilation.

The primary goal is to achieve a better circadian activity ratio post-extubation, with additional outcomes measuring melatonin levels, EEG activity, and overall patient comfort, highlighting the importance of a healing environment in pediatric intensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a two-center test of a nurse-implemented chronotherapeutic restoring bundle in critically ill children: RESTORE Resilience (R2). Perry, MA., Dawkins-Henry, OS., Awojoodu, RE., et al.[2023]

One-third of patients experience sleep disruption due to overnight light exposure, which not only disturbs immediate sleep but also affects circadian rhythms essential for quality sleep.

A longitudinal study in ICU rooms revealed that light levels were highly variable, with dim daytime light and reduced natural sunlight, indicating that these noncircadian light patterns could significantly impact sleep quality and should be addressed to improve patient rest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light Levels in ICU Patient Rooms: Dimming of Daytime Light in Occupied Rooms. Lusczek, ER., Knauert, MP.[2021]

Children aged 1 to 2 years in the pediatric intensive care unit (PICU) experienced significant sleep disturbances, including reduced total sleep time and frequent awakenings, compared to their pre-illness sleep patterns.

Environmental factors such as light, noise, and caregiver activity negatively impacted sleep quality, and changes in sleep patterns persisted even after discharge from the hospital, indicating a need for improved sleep management in intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep of 1- and 2-year-old children in intensive care. Corser, NC.[2019]

Children in the pediatric intensive care unit (PICU) experience disrupted and fragmented sleep, which is crucial for their growth and healing, highlighting the need for improved sleep strategies similar to those used for adults in ICUs.

Current research on sleep in critically ill children is limited and inconsistent, with a call for future studies to use standardized measurements and definitions to better understand and address sleep issues in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Intensive Care Unit related Sleep and Circadian Dysregulation: a focused review. Hassinger, AB., Afzal, S., Rauth, M., et al.[2023]

Critically ill patients in ICUs often experience disturbed sleep-wake patterns, which can negatively impact their brain function and overall outcomes, highlighting the need for effective interventions.

This systematic review of 10 studies involving 1,278 patients suggests that light therapy may help improve sleep quality and clinical outcomes in ICU patients, but further research with standardized methods is necessary to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure to light and darkness and its influence on physiological measures of intensive care unit patients-a systematic literature review. Weiss, B., Spies, C., Piazena, H., et al.[2018]

This pilot study aims to explore the relationship between environmental factors (light and sound exposure), caregiving patterns, and sleep disruption in 10 critically ill children aged 1-4 years in the pediatric intensive care unit (PICU), addressing a gap in understanding how these factors contribute to delirium.

The study employs innovative methods such as bedside sensors for light and sound, video recordings for caregiving, and actigraphy for sleep measurement, which could lead to improved interventions for sleep promotion in critically ill pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disruption and delirium in critically ill children: Study protocol feasibility. Kalvas, LB., Harrison, TM., Solove, S., et al.[2023]

Critically ill children in the pediatric intensive care unit (PICU) often experience significant sleep disruption due to the effects of sedative and analgesic medications, which can negatively impact both short-term recovery and long-term neurocognitive outcomes.

Increased doses of sedatives intended to improve sleep quality can paradoxically lead to more agitation and poorer sleep, highlighting the need for careful management of sedation in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep of critically ill children in the pediatric intensive care unit: a systematic review. Kudchadkar, SR., Aljohani, OA., Punjabi, NM.[2021]

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