Circadian DysregulationNCT07384585
Feasibility of Light Therapy in the Pediatric Intensive Care Unit (ICU)
A study testing Light Therapy in people with Circadian Dysregulation and Light Exposure, run by Laura Beth Kalvas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Circadian Dysregulation, Light Exposure, Pediatric Critical Illness
- What is being tested?
- Light Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Anticipated to remain admitted to the study hospital pediatric ICU for additional 48 hours
- English-speaking parent/legally authorized representative available at the bedside
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Laura Beth Kalvas, PhD, RN, 614-304-1872, laurabeth.kalvas@nationwidechildrens.org
About this study
Official title: Feasibility of Light Therapy in the Pediatric ICU
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.
- Being tested
- Light Therapy
- Medical subject headings
- Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light TherapyOther
Also called bright light exposure
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.
| Study group | Role | What they receive |
|---|---|---|
| Light Therapy | Experimental | Not described Receives: Other: Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of light therapy for children, families, and staff.
Feasibility of light therapy assessed via feedback surveys from children, families, and clinical staff.
Measured: Maximum of 5 days of light therapy.
Duration of light therapy
Hours of light therapy received per study day.
Measured: Maximum of 5 days of light therapy.
Secondary outcomes (2)
Adverse side effects of light therapy.
For each day of light therapy, presence of commonly reported side effects of light therapy (e.g., headache, eye strain, nausea, agitation) will be monitored and recorded in a daily monitoring form. Unanticipated problems and reportable adverse side effects will be monitored and recorded in an adverse event form. Presence of side effects will be determined from speaking with the bedside nurse, parent/caregiver, and child, review of the electronic medical record, and child/family/staff feedback surveys.
Measured: Maximum of 5 days of light therapy.
Light levels
Continuous bedside monitoring of light levels in lux via a light meter.
Measured: Maximum of 5 days of light therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start26 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian DysregulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laura Beth Kalvas
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Sponsor-investigator, Laura Beth Kalvas, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384585
- Sponsor's protocol ID
- STUDY00005565
- Status last verified
- Mar 2026
- First submitted
- 21 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of this small clinical trial testing feasibility of light therapy in the pediatric ICU will be shared in aggregate via publication at presentations at the study hospital and conferences.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Light Therapy in the Pediatric ICU
- ClinicalTrials.gov ID
- NCT07384585
- Acronym / sponsor ID
- STUDY00005565
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Laura Beth KalvasUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Light Therapy | Experimental | Other: Light Therapy |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Anticipated to remain admitted to the study hospital pediatric ICU for additional 48 hours
- English-speaking parent/legally authorized representative available at the bedside
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light TherapyAlso: bright light exposureLight 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. | Other | Light Therapy |
Primary outcome
Feasibility of light therapy for children, families, and staff.
Time frame: Maximum of 5 days of light therapy.
Feasibility of light therapy assessed via feedback surveys from children, families, and clinical staff.
Duration of light therapy
Time frame: Maximum of 5 days of light therapy.
Hours of light therapy received per study day.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. Results of this small clinical trial testing feasibility of light therapy in the pediatric ICU will be shared in aggregate via publication at presentations at the study hospital and conferences.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Therapy in people with Circadian Dysregulation and Light Exposure, run by Laura Beth Kalvas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Beth Kalvas, PhD, RN (614-304-1872, laurabeth.kalvas@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of light therapy for children, families, and staff. (time frame: Maximum of 5 days of light therapy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.