NCT06496477

Light Therapy to Treat Depression in Pediatric Stem Cell Therapy Recipients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The participants are being asked to be in this clinical trial, a type of research study, because the participants are going to have a hematopoietic stem cell transplant (HSCT) in the near future. Participants that get HSCT's often get depression and/or suffer from depressive symptoms, tiredness, and sleep disturbances. Primary Objective To evaluate the efficacy of BL therapy for the treatment of depression in children and adolescents undergoing hematopoietic stem cell transplant. Secondary Objectives * To evaluate the temporal effect and magnitude of BL vs. DL therapy on depression in pediatric patients undergoing HSCT. * To evaluate the efficacy of BL therapy for the treatment of fatigue in children and adolescents undergoing hematopoietic stem cell transplant. * To evaluate the response of BL therapy versus DL on sleep quality. Exploratory Objectives * To compare incidence of positive delirium screenings between those receiving BL therapy versus DL * To evaluate participant and caregiver perceptions of the acceptability, ease of use, and risks/benefits of the use of Light Therapy Glasses during HSCT utilizing qualitative interviews.

Detailed description

If you decide to be in this study, you will be asked to: * Complete some surveys before the study begins * Take more surveys for about 4 weeks * Wear light therapy glasses for about 30 minutes each day for about 4 weeks * Wear a wrist monitor every day and night for the 1st and last week of the study to record your motion and sleeping habits. * Keep a ''sleep diary" where you will mark the times that you sleep while wearing the wrist monitor. * Complete an optional interview at the end of the study.

Conditions

• Hematopoietic Stem Cell Transplant

Interventions

Type	Name	Description
DEVICE	Ayo wearable	Primary study device - the Ayo wearable which are glasses that emit either bright blue-spectrum white light or dim blue-spectrum white light or Mini motion logger AAM-32 - an actigraphy device work during the first and last week of the study on the participants wrist throughout most of the day, measuring activity. This will be used as an indicator of sleep.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2024-07-11
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study