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

NCT07384585 | Recruiting

• 1 other identifier: STUDY00005565
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Circadian Dysregulation; Light Exposure; Pediatric Critical Illness

Outcome Measures

Primary Outcomes (2)

• Feasibility of light therapy for children, families, and staff.

  Feasibility of light therapy assessed via feedback surveys from children, families, and clinical staff.

  Maximum of 5 days of light therapy.

• Duration of light therapy

  Hours of light therapy received per study day.

  Maximum of 5 days of light therapy.

Secondary Outcomes (2)

• Adverse side effects of light therapy.

  Maximum of 5 days of light therapy.

• Light levels

  Maximum of 5 days of light therapy.

Study Arms (1)

Light Therapy

EXPERIMENTAL

Other: Light Therapy

Interventions

Light Therapy OTHER

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 time if requested by the child, family, or staff.

Also known as: bright light exposure

Light Therapy

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laura Beth Kalvas: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

MeSH Terms

Conditions

Chronobiology Disorders

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Laura Beth Kalvas, PhD, RN

CONTACT

614-304-1872; laurabeth.kalvas@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse Scientist

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)