Light Therapy to Treat Depression in Pediatric Stem Cell Therapy Recipients

Not Applicable

Not yet recruiting

• Conditions: Hematopoietic Stem Cell Transplant
• Interventions: Device: Ayo wearable

• Registration Number: NCT06496477
• Lead Sponsor: St. Jude Children's Research Hospital

Brief 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
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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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2024-07-03
• Study First Posted: 2024-07-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16
• Study Start: 2024-12
• Primary Completion: 2027-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 98

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1-A bright blue-spectrum white light (BL	Ayo wearable	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
Group 2- A dim blue-spectrum white light control (DL	Ayo wearable	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

Primary Outcome Measures

Name	Time	Method
Depression Efficacy	Baseline	Depressive symptoms will be assessed using the PROMIS Ped CAT v2.0 - Depressive Symptoms (Patient and Parent Proxy, though Patient report will be used for stratification and is the primary outcome measure and basis for stratification). Participants meet all eligibility criteria including baseline PROMIS scores of 55 or above will be stratified by these score...

Secondary Outcome Measures

Name	Time	Method
Fatigue Efficacy" (though we will also have data for magnitude and temporality given data collection is identical to the primary objective)	Baseline	PROMIS Ped CAT v2.0 - Fatigue (Patient and Parent Proxy)
Magnitude and Temporality of Effect in Depression	Baseline	Depressive symptoms will be assessed using the PROMIS Ped CAT v2.0 - Depressive Symptoms (Patient and Parent Proxy, though Patient report will be used for stratification and is the primary outcome measure and basis for stratification). Participants meet all eligibility criteria including baseline PROMIS scores of 55 or above will be stratified by these score...
Impact on Sleep Quality"	Actigraphy devices will be worn for at least 3 days from day 0 - day 7 ± 3 days post-transplant and at least 3 days from day 21 - 28 ± 3 days post-transplant	Participants will wear actigraphy devices (the Mini Motion Logger AAM-32) for at least 3 days from day 0 - day 7 ± 3 days post-transplant (baseline sleep measures) and at least 3 days from day 21 - 28 ± 3 days post-transplant. Actigraphy devices will be distributed at day 0 and 21 ± 3 days post-transplant and collected on day 7 and 28 ± 3 days post-transplan...

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States