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Recruiting NCT07384585

Feasibility of Light Therapy in the Pediatric Intensive Care Unit (ICU)

No phase Interventional Circadian Dysregulation Light Exposure Pediatric Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Light Therapy.
Who it may be relevant to
Registry conditions: Circadian Dysregulation, Light Exposure, Pediatric Critical Illness. Basic parameters: 4 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Feasibility of Light Therapy in the Pediatric ICU

Overview

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.

Interventions

  • Other Light Therapy
    Light therapy will be delivered via a light box for a maximum of 5 days in the pediatric ICU. Light therapy will be initiated 1 to 2 hours following participant's typical wake time, and continue for 3 hours. The light box light intensity is 10,000 lux with high blue light content (5,000 Kelvin). The light box blocks ultraviolet rays. The portable light box will be placed in front or to the side of the child at a distance of 2 feet. The light box can be moved with activity and turned off at any t

Primary outcome measures

  • Feasibility of light therapy for children, families, and staff. [Time frame: Maximum of 5 days of light therapy.]
  • Duration of light therapy [Time frame: Maximum of 5 days of light therapy.]
Secondary outcome measures (2)
  • Adverse side effects of light therapy. [Time frame: Maximum of 5 days of light therapy.]
  • Light levels [Time frame: Maximum of 5 days of light therapy.]

Eligibility criteria

Inclusion criteria

  • Anticipated to remain admitted to the study hospital pediatric ICU for additional 48 hours
  • English-speaking parent/legally authorized representative available at the bedside

Exclusion criteria

  • Patients unable to open their eyes to receive light therapy (Glasgow Coma Scale eye opening score of 1 or neuromuscular blockade)
  • Patients with contraindications to light therapy (e.g., migraines, retinal disease, diseases associated with retinal complications, blindness, bipolar disorder, seizure disorder, traumatic brain injury)
  • Suspected/identified neglect/abuse, Child Protective Services involvement, or ward of state
  • Children receiving palliative/end-of-life care
  • Unable to fit light box/cart in patient room

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Nationwide Children's Hospital — Columbus

Identifiers

NCT: NCT07384585 · STUDY00005565

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗