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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Daytime light exposure and Daytime restricted feeding for insomnia in critically ill children?

Research suggests that light therapy can help maintain and reset the body's internal clock, which may improve sleep patterns. Additionally, strategies to improve sleep in intensive care settings have shown benefits in adults, such as reduced delirium and better recovery, which could be relevant for children as well. ^{1 2 3 4 5}

Is daytime light exposure safe for humans?

Daytime light exposure is generally considered safe for humans and has been used to help maintain and resynchronize circadian rhythms (the body's internal clock) in various settings, including intensive care units. However, more research with clearly defined interventions and objective outcome measures is needed to fully understand its effects. ^{1 2 4 5 6}

How does the treatment of daytime light exposure and restricted feeding differ from other treatments for insomnia in critically ill children?

This treatment is unique because it focuses on using natural light exposure during the day and restricting feeding to daytime hours to help regulate the child's internal clock (circadian rhythm), which is often disrupted in the intensive care environment. Unlike traditional treatments that may rely on medications, this approach aims to restore natural sleep patterns through environmental and behavioral changes. ^{2 3 4 5 7}

Eligibility Criteria

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.

I have an English-speaking parent with me.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Pediatric Intensive Care Unit related Sleep and Circadian Dysregulation: a focused review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Netherlands 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). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Sleep disruption and delirium in critically ill children: Study protocol feasibility. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Light Levels in ICU Patient Rooms: Dimming of Daytime Light in Occupied Rooms. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Sleep of critically ill children in the pediatric intensive care unit: a systematic review. [2021]