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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
Disqualifiers: Migraines, Retinal disease, Bipolar, others
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?

The goal of this clinical trial is to understand how easy or difficult it is for critically ill children (4-17 years old) to have light therapy while in the pediatric ICU. Participants will have a light meter at their bedside to measure light levels. Each morning, a light box will be placed at their bedside. Children, family, and staff will be asked to completed feedback surveys regarding the light therapy. Study participation will continue for a maximum of 5 days.

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+

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