Recruiting

Light Therapy

Sponsor:

Laura Beth Kalvas

Code:

NCT07384585

Conditions

Circadian Dysregulation

Light Exposure

Pediatric Critical Illness

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Interventions

Light Therapy

Study Details

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

Study ID

NCT07384585

Start date

Mar 26, 2026

Status verified date

Mar, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Light Therapy

Interventions

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

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Laura Beth Kalvas, PhD, RN

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

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Laura Beth Kalvas, PhD, RN

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

More Information

Sponsor

Laura Beth Kalvas

Last update posted

May 22, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laura Beth Kalvas on 2026-05-22.