Light Therapy for Sleep Disorders in Critically Ill Children

LB
Overseen ByLaura Beth Kalvas, PhD, RN
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Laura Beth Kalvas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well critically ill children in the pediatric ICU respond to light therapy for sleep disorders. Each morning, a light box will be placed by their bedside, and a small device will measure the light levels. Feedback from the children, their families, and the staff will help assess the therapy’s impact. Children who have been in the ICU for less than 48 hours and are expected to stay for at least two more days may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding how light therapy can improve sleep in critically ill children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that light therapy is safe for critically ill children?

Research has shown that light therapy can improve sleep in seriously ill children. Studies have found that exposure to sufficient daylight can reset their internal body clocks, leading to better sleep. No major safety issues have been reported with this therapy so far. Light therapy is generally easy for children to handle without problems. During the trial, a light box will be placed next to the child's bed, and both the children and their families will share their experiences. This feedback ensures the therapy remains comfortable and safe to use in the ICU.12345

Why are researchers excited about this trial?

Light therapy is unique because it offers a non-invasive way to help critically ill children with sleep disorders. Unlike medications that may come with side effects or take time to show results, light therapy works by adjusting the body's internal clock, potentially leading to quicker improvements in sleep patterns. Researchers are excited about this approach because it targets the root of sleep disturbances by influencing natural circadian rhythms, offering a promising alternative to traditional drug-based treatments.

What evidence suggests that light therapy might be an effective treatment for sleep disorders?

This trial will investigate the effects of light therapy on sleep disorders in critically ill children. Research has shown that daylight can improve sleep in seriously ill children by resetting their internal body clocks. This is particularly beneficial in environments like the pediatric ICU, where natural light may be limited. A study on bright light therapy found it improved sleep problems in children with autism, suggesting potential benefits for others. Additional research indicates that low-level light therapy can reduce insomnia and related psychological symptoms in hospitals. While these findings are promising, the strength of the evidence varies, and further studies are needed to confirm the full benefits for critically ill children.13678

Are You a Good Fit for This Trial?

This trial is for critically ill children aged 4-17 in the pediatric ICU with conditions like disrupted sleep-wake cycles or sleep disorders. The study aims to assess how feasible light therapy is for these patients over a maximum of 5 days.

Inclusion Criteria

I have an English-speaking guardian with me.
Within 48 hours of pediatric ICU admission at study hospital
Anticipated to remain admitted to the study hospital pediatric ICU for additional 48 hours

Exclusion Criteria

Patients unable to open their eyes to receive light therapy (Glasgow Coma Scale eye opening score of 1)
I do not have conditions like migraines or retinal disease that make light therapy unsafe for me.
Suspected/identified neglect/abuse, Child Protective Services involvement, or ward of state
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive light therapy in the pediatric ICU with continuous monitoring of light levels and feedback surveys

5 days
Daily bedside visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Light Therapy

Trial Overview

The intervention being studied is light therapy, which involves placing a light box at the bedside each morning and measuring light levels. Feedback from children, families, and staff will be collected to evaluate the process.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Light TherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Laura Beth Kalvas

Lead Sponsor

Nationwide Children's Hospital

Collaborator

Trials
354
Recruited
5,228,000+

Citations

Sleep of Critically Ill Children in the Pediatric Intensive Care Unit

Results from the control nights demonstrated a mean number of awakenings was 24.9 events/hr (SD: 10.3), with an average total sleep time of 4.2 hours (SD: 0.2 ...

Daytime Light Exposure 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 ...

Umbrella Review and Meta-Analysis: The Efficacy of ...

For those with autism, sleep disturbance improved (mean SMD = 0.70). However, all findings were of low to very low certainty of evidence. Conclusion. Among ...

Bright Light Therapy as Add-On to Inpatient Treatment in ...

This randomized clinical trial evaluates bright light therapy vs treatment as usual for youth with depression.

The Effectiveness of Using Low-level Light Therapy to ...

The purpose of this study is to explore the treatment of Low Level Light Therapy(LLLT) mitigate possible insomnia and psychological symptoms, when nurses have ...

Sleep quality and factors that disturb sleep among infants ...

This study aimed to investigate children's sleep quality in the pediatric intensive care unit and factors that disturb their sleep.

Sleep disorders in children - PMC - NIH

In this systematic review we present information relating to the effectiveness and safety of the following interventions: antihistamines; behavioural therapy ...

Improve sleep in critically ill patients - Research journals - PLOS

In critically ill patients, sleep and circadian rhythms are greatly altered. These disturbances have been associated with adverse consequences, ...