Light Therapy to Treat Depression in Pediatric Stem Cell Therapy Recipients

St. Jude Children's Research Hospital

Status: Not yet enrolling

Conditions: Hematopoietic Stem Cell Transplant

Treatments: Device: Ayo wearable

Study type: Interventional

Funder types: Other

Identifiers

NCT06496477

NCI-2025-03591 (Other Identifier)

SJLIGHT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥8 to <18 years of age at the time of enrollment
• Allogeneic HSCT planned to occur between 7 and 10 days in the future from recruitment
• Patient and/or primary caregiver reads and writes in English or Spanish
• Participant/guardian is willing to sign informed consent
• Optional interview participants must be English speaking
• Baseline self-report of depressive symptoms on the PROMIS® Pediatric Depressive Symptoms v3.0 (PROMIS-PedDepSx) ≥ 55

Exclusion criteria

• Taking photosensitizing medications
• Total blindness / complete lack of light perception bilaterally
• Significant physiological or psychological impairment that interferes with participation
• Any patient that, in the opinion of the primary investigator is not appropriate for the study
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
• Non-English-speaking participants will not be eligible for the optional qualitative interview
• Baseline self-report of depressive symptoms on the PROMIS® Pediatric Depressive Symptoms v3.0 (PROMIS-PedDepSx) < 55

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Group 1-A bright blue-spectrum white light (BL

Active Comparator group

Description:

Participants will receive therapy with bright blue-spectrum white light (BL) for up to thirty minutes each day for 28 days during their HSCT related hospital admission

Treatment:

Device: Ayo wearable

Group 2- A dim blue-spectrum white light control (DL

Active Comparator group

Description:

Participants will receive therapy with dim blue-spectrum white light control (DL) for up to thirty minutes each day for 28 days during their HSCT related hospital admission

Treatment:

Device: Ayo wearable